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Assessment of noninvasive predictors of bladder outlet obstruction and acute urinary retention secondary to benign prostatic enlargement

Osama Abdel-Wahab et al
Abstract Purpose: To prospectively compare the diagnostic accuracy of intravesical prostatic protrusion (IPP), detrusor wall thickness (DWT), prostate volume (PV) and serum prostate specific antigen (PSA) levels for detecting bladder outlet obstruction (BOO) and predicting acute urinary retention (AUR) secondary to benign prostatic obstruction. Patients and methods: In all, 135 men who presented with lower urinary tract symptoms due to benign prostatic enlargement were enrolled in the study; among them, 50 presented with AUR. Thirty normal men in the same age group were included and represented a control group for normative data. Their evaluation included a digital rectal examination, International Prostate Symptom Score and quality-of-life question, uroflowmetry and serum total PSA assay. Transabdominal ultrasonography was used to measure the PV, IPP DWT and post-void residual urine volume. Pressure-flow urodynamic studies were used as the reference standard test for BOO, differentiating obstructed from unobstructed bladders. DWT, IPP, PV and total PSA level served as index tests. To compare the usefulness of the various indices, the area under the curve (AUC) of receiver-operator characteristic curves was calculated for each index.
Results: According to presentation and urodynamic studies, patients were classified into three groups: Group 1 (no BOO), 50 patients with a BOO index (BOOI) of <40; group 2 (BOO), 35 with a BOOI of >40; and group 3 (AUR), 50 who presented with AUR. The IPP, DWT, PV and PSA levels differed significantly between obstructed and unobstructed patients, with a significant correlation with the BOOI. The AUC for IPP, DWT, PSA and PV were 0.885, 0.783, 0.745 and 0.678, respectively. The IPP threshold at 8 mm provided the best diagnostic accuracy (80%) for detecting BOO, followed by combined DWT and IPP (77.6%). Between patients with and without AUR, there was a highly significant difference in IPP, DWT and PSA; a combined IPP threshold of >8 mm and DWT >2 mm detected AUR in 45 of 50 patients (90%). Conclusion: All four noninvasive indices were correlated significantly with BOOI. The IPP as a single variable and combined with DWT predicted BOO and AUR better than PSA or PV. ª 2011 Arab Association of Urology. Production and hosting by Elsevier B.V. All rights reserved .
Introduction
BPH is a pathological process that contributes to, but is not the sole cause of, LUTS in ageing men [1]. BOO is obstruction during voiding and is characterized by increased detrusor pressure and a reduced urinary flow rate [2]. The standard for diagnosing
BOO is pressure-flow studies (PFS) that offer information regarding the degree of BOO through measuring the BOO index (BOOI) [3]. However, the routine use of PFS in clinical application at most centres is limited, because they are invasive and have potential complications [4], beside being time-consuming and using personal and financial resources. Thus, a noninvasive, quick, unexpensive and easily available diagnostic tool with a high specificity and sensitivity for determining BOO would be ideal. Recent studies suggested that assessing of detrusor wall thickness (DWT) [5–7] and intravesical prostatic protrusion (IPP) [7–10] by transabdominal ultrasonography (TAUS)
might be useful for diagnosing BOO. Also, it was reported that the grade of IPP can predict the success rate of avoiding trial without catheterization after an episode of acute urinary retention (AUR) and be helpful in clinical decision-making [9]. Therefore, the aim of the present study was to prospectively evaluate the clinical utility of DWT, IPP, prostate volume (PV), and PSA measurements as noninvasive predictors of
BOO and AUR in patients with symptomatic BPH. Patients and methods From September 2008 to October 2010, 155 consecutive men aged >50 years, presenting with LUTS suggestive of benign prostatic enlargement (BPE), were recruited. Exclusion criteria
included prostate cancer, previous prostate surgery, neurogenic bladder, diabetes mellitus, vesical stones, UTI, urethral strictures and chronic urinary retention. Patients on current a-blockers or on 5a-reductase inhibitors were also excluded. Twenty cases were excluded, 12 according to exclusion criteria (vesical calculi in four, chronic retention in three, neurogenic bladder in two, urethral stricture in two and cancer of the prostate in one), and eight due to an incomplete data set. Thus 135 patients fulfilled the inclusion and exclusion criteria, and had a complete data set, comprised the study population. Among them, 50 patients presented with AUR and failed at least one trial of voiding without catheterisation. Thirty normal volunteers were included as a control group in the noninvasive part of the study, to obtain normative data. The evaluation included a DRE, IPSS with the quality-of-life (QoL) question,
and serum PSA measurement. The patients with AUR were asked to record their symptoms for 1 month before the onset
of retention. The study was approved by the local ethical committee and all men gave written informed consent.
For TAUS, we used a Model SSA-350 A machine (Toshiba Inc., Tokyo, Japan) with a 3.5-MHz convex probe and a 7.5-MHz linear probe scan administered by one operator (H.F.)
to measure the IPP, PV, postvoid residual urine volume (PVR) and DWT. At a bladder volume of 150–200 mL the
PV and IPP were evaluated, with PV calculated using the ellip soid formula, p/6 · prostate width · height · depth.
The IPP was assessed using a 3.5-MHz probe in the mid-sagittal plane, and defined as the vertical distance from the tip of the prostatic protrusion to the bladder circumference at the prostate base (Fig. 1). The IPP grade was determined as: grade I, <5 mm; grade II, 5–10 mm; and grade III, >10 mm [9]. DWT was measured using the 7.5-MHz linear probe in the horizontal direction at maximum magnification, when the bladder volume was 200 mL, by natural filling in patients without retention, or by infusion through the indwelling catheter in patients with AUR (Fig. 2). The outer and inner detrusor muscle surfaces were identified by hyperechogenic lines corresponding to subserosal tissue and to bladder mucosa plus submucosal tissue, respectively. The hypoechogenic layer in between corresponding to the detrusor wall was measured at three points of the anterior bladder wall, 1 cm apart, and a mean value was recorded for further calculation [5]. PFS were conducted in patients presenting with LUTS sug gestive of benign prostatic obstruction (BPO). According to the ICS recommendations [11] using a urodynamic unit (Ellipse 4, Andromeda Medizinische System, Germany), the extent of BOO was calculated as the BOOI, also known as the Abrams–Griffith score. A BOOI of >40 indicates definite obstruction, 20–40 is equivocal and <20 indicates no obstruc tion [2]. The investigator responsible for urodynamics was una ware of the TAUS results. Obstructed and unobstructed bladders were divided on the basis of the PFS analysis, which served as the reference standard test for BOO. The TAUS mea sured DWT, IPP, PV, and total PSA level, served as index tests. The data distribution was not normal and nonparametric tests were used. Differences in clinical and urodynamic characteristics among the groups were evaluated by the nonparametric Kruskal–Wallis test and Mann–Whitney U-test for pair-wise comparison of continuous data, as appropriate. Obstructed and unobstructed patients were compared using the chi-square and Fisher’s exact test with risk estimates as appropriate. Correlations were quantified using the nonparametric Spearman’s rank correlation (rho) to detect correlations between BOOI and other variables. Receiver operator characteristic (ROC) curves were produced to evaluate the area under the curve (AUC) and the diagnostic performance of IPP, DWT, PV and PSA for BOO. The AUC was calculated to determine the strength of association, considering an AUC of 0.5 to be no association and an AUC of 1.0 to be the best possible association. The diagnostic accuracy for BOO was calculated for IPP, DWT, PV and PSA. Data are shown as the mean (SD) and P < 0.05 was considered to indicate statistical significance.
Results Patients without AUR were assigned into two groups accord ing to BOOI. Group 1 (no BOO) included 50 patients, of
whom 17 had a mean (SD, range) BOOI of 12.7 (4.4, 3–17) and 33 had equivocal BOOI, with a mean (SD, range) BOOI
of 28.2 (4.6, 20–36). There was no significant difference between patients with unobstructed and equivocal BOOI for
the other variables of age, IPSS, QoL, PV, PSA, PVR, maximum urinary flow rate (Qmax), DWT and IPP, hence they were
considered as one group. Group 2 (BOO) included 35 men with a BOOI of >40. The 50 men who presented with AUR
were classified as group 3. There was a significant difference between normal men and patients with symptomatic BPE
(group 1 and 2) in all variables except for IPP, where it was insignificant between the control and group 1. The difference
between obstructed and unobstructed patients was significant for IPP, DWT, Qmax, PSA, PV, IPSS and QoL (Table 1).
Spearman’s rho between the variables in group 1 and group 2 and BOOI showed significant positive correlations with IPP
(correlation coefficient 0.595, P < 0.001), DWT (0.422, P < 0.001), PSA (0.341, P = 0.001) and a modest correlation
with PV (0.241, P = 0.02).
A ROC curve was produced in patients confirmed to be obstructed or not, and the AUC computed for the prognostic
value of IPP, DWT, PSA and PV to diagnose BOO (Fig. 3).
The AUC (95% CI) for IPP was 0.885 (0.806–0.963), for DWT was 0.783 (682–0.885), for PSA was 0.745 (0.638–0.851), and for PV was 0.678 (0.562–0.794). The best threshold value for IPP was 8 mm, for DWT was 2 mm, for PSA was
2.5 ng/mL and for PV was 45 mL. Detrusor overactivity (DO) was significantly associated
with obstruction, being detected in seven of 35 (20%) obstructed patients, but in two of 50 (4%) unobstructed men
(P = 0.01, odds ratio 0.474, 95% CI 0.3–0.748). An interesting finding in patients with DO was a significantly higher mean
IPP of 9.9 (3.9) mm vs. 6.1 (4.8) mm (P = 0.03) in patients without DO. The mean DWT was 2.5 (0.1) mm in patients
with DO and 1.9 (0.5) mm in patients without (P = 0.001;data not shown).
The performance of thresholds for different indices in detecting BOO is shown in Table 2. At a threshold of 8 mm
the IPP had a positive predictive value (PPV) of 73.7%. Table 3 shows a comparison of clinical variables in patients
with and without AUR. There was a highly significant difference in IPP (P < 0.001), followed by DWT (P = 0.001).
A combined IPP of >8 mm and DWT of >2 mm detected AUR in 45 of the 50 patients (90%).
Discussion BPO is the most frequent pathophysiological process causing
LUTS in elderly men. PFS is considered the standard method for diagnosing BOO, although its routine use is questioned and
is associated with morbidity as it is an invasive procedure [4].
The urinary flow rate is recommended as a noninvasive test, but it is considered inaccurate for the precise diagnosis of
BOO [12] and most patients with BPH present with a higher IPSS, lower Qmax and higher PVR [7].
The IPP, as measured by TAUS, is caused by the enlarging lateral lobes and the median lobe inside the bladder causing
BOO by a ball-valve mechanism [9] disrupting the funnelling effect of the bladder neck and causing dyskinetic movement
of the bladder during voiding [13]. Hence measuring the IPP gives some idea of the obstruction as a causal relationship.
The mean IPP differed significantly between normal men and patients with LUTS, either unobstructed (group 1) or obstructed (group 2). The mean (range) IPP was 3.99 (0–11.6) mm in unobstructed men, 10 (0–21) mm and 12.7 (0–33.5) mm in obstructed men and those who presented with AUR, respectively. In normal men the mean (SD, range) IPP
was 2.7 (1.8, 0–8.7) mm (Tables 1 and 3).
The best threshold for IPP was 8 mm, for DWT 2 mm, for PSA 2.5 ng/mL and for PV 45 mL, giving the highest sensitivity and specificity at the same time in the ROC curve.
An IPP of >8 mm was found in 28/35 (80%) of obstructed men and in 10/50 (20%) of those without BOO (P < 0.001,
odds ratio 0.202, 95% CI 0.099–0.411). Using the same thresholds in patients who presented with AUR, 40 of the 50 (80%)
had an IPP of >8 mm with a significant association, as shown by the odds ratio and 95% CI (Table 4). These results agree with those reported in earlier studies [8–10], where IPP grade III (>10 mm) was found in 76% of obstructed cases, with a
PPV of 94% and negative predictive value (NPV) of 74%. IPP grade III was found in 67% of patients who presented
with AUR in the study of Tan and Foo [10], and 71% in the study of Lim et al. In the present study, the AUC of the ROC curve for IPP was
0.885 (95% CI 0.806–0.963) and at a threshold of 8 mm, the sensitivity was 80%, the specificity was 80%, the PPV 73.7%, the
NPV 85.1%. The IPP had a positive correlation with the severity of obstruction as defined by the higher BOOI (correlation
coefficient 0.595, P < 0.001). A significant correlation was reported by Chia et al. , with a PPV of 94% and NPV of
79%. The AUC for IPP was 0.772 in the study of Lim et al.
; the AUC for IPP was 0.835 at a threshold of 12 mm. Francoet al. reported a sensitivity of 0.65 and specificity of 0.77, with an 88% PPV, but a higher threshold was used in that study than in the present study. DWT is a new method to diagnose BOO that is based on the findings of thickened detrusor and increased bladder weight after inducing BOO in experimental animals , and that can
be visualized and measured with ultrasonography [5,15] using high-frequency ultrasound arrays (Ph7.5 MHz) and magnification. In the present study the mean DWT in unobstructed patients was 1.7 mm, while it was 2.2 mm in patients with
obstruction, and 2.3 mm in patients with AUR. DWT was significantly correlated with BOOI (correlation coefficient
0.422, P < 0.001). These findings agree with those of Oelke et al. , who found a mean DWT of 2.4 mm in 33 obstructed
patients, and the median DWT was 1.7 mm in a recent study of 75 obstructed patients [6]. Our results for DWT were different from those of Franco et al. , in which they reported a mean DWT of 7.1 mm, possibly due to a different method of
measurement, as we measured only the hypoechogenic portion of the detrusor wall between the two hyperechogenic lines corresponding to the inner and outer layers of the bladder wall .
The AUC of the ROC curve for DWT was 0.783, and at a 2-mm threshold the sensitivity was 65.7% and the specificity 76%. Also, a DWT of >2 mm was significantly associated with 80% of patients with AUR (Table 4). These findings agree
with those of Oelke et al. who found an AUC of 0.882. Our results showed that DWT was significantly correlated with
BOOI, with a PPV of 65.7% and NPV of 76%. In this study the DWT threshold was similar to that in the study of Oelke
et al. , who were investigating the accuracy of DWT as a
noninvasive method to predict BOO. The threshold in the study of Manieri et al. was 5 mm for bladder wall thickness, and in a more recent study it was 6 The AUC for DWT was 0.845, and at a 6-mm threshold Franco et al. reported a sensitivity of 0.73 and specificity 0.82, showing that patients with a DWT of P5 mm had an 88% risk of obstruction on PFS [15]. These findings agree with the results of the present study, despite the different methods used to assess DWT in those studies. US measurement of the detrusor thickness identified as the middle hypoechogenic layer seems to be more appropriate than assessment of the entire bladder wall
, as in the previously mentioned study . At a threshold of 2 mm Kessler et al. [16] found a sensitivity of 92%, specificity of 68%, PPV of 81% and NPV of 85%, while a smaller threshold of 1.5 mm improved the sensitivity to 100% but reduced the specificity to 41%. Also in the recent study of Oelke et al. , at a threshold of 2 mm for DWT, the sensitivity was 83%, specificity 95%, PPV 94% and NPV 86%.
PSA and PV have been extensively studied as predictors of BOO . In the present study PSA and PV had significant
positive correlations with BOOI. The AUC (95% CI) for PSA was 0.745 (0.638–0.851) and at a 2.5 ng/mL threshold the sensitivity was 74.3%, specificity 50%, PPV 51% and NPV 73.5%. A PSA level of >2.5 ng/mL was significantly associated with 84% of patients with AUR.
The AUC of the ROC for PV was 0.678 (0.562–0.794) and at a threshold of 45 mL the sensitivity was 85.7% and specificity 26%, PPV 48.6% and NPV 72.2%, i.e. PV had a lower specificity for detecting obstruction. These results had some
differences from those reported by Lim et al. In that study, the AUC for PV was 0.637 and the sensitivity was 51%, specificity 38%, PPV 65% and NPV 42%, possibly because of the lower threshold (40 mL) used in that study, where the AUC
was 0.703 for PSA, with a sensitivity of 30%, specificity 70%, PPV 68% and NPV 38% at a threshold of 4 ng/mL.
At a threshold of 25 mL for PV in another study [6], the sensitivity was 85%, specificity 27%, PPV 51% and NPV 67%,
at a lower threshold than in the present study.
In the developing array of noninvasive clinical predictors of BOO and AUR, IPP and DWT compare well with serum PSA
level and PV. US measurement of IPP and DWT can be easily obtained with the TAUS in the outpatient setting, with no
need for a rectal probe or sophisticated urodynamic study.
In conclusion, this study shows that US measurements of IPP and DWT are accurate noninvasive alternatives to PFS
for assessing the presence of BOO due to BPE. The combination of IPP and DWT had a higher sensitivity and specificity at
same time, and higher accuracy than when individually measured. The significant association of higher IPP and DWT with
an increased risk of AUR suggests that these measures would be promising as noninvasive variables capable of identifying
patients at increased risk of AUR.

Bipolar vaporization of the prostate may cause higher complication rates compared to bipolar loop resection: a randomized prospective trial

Osama Abdelwahab1 et al
Abstract Introduction Transurethral resection of the prostate (TURP) by resection loop or vaporization button is becoming a standard of care due to its better safety profle (less bleeding and less incidence of TUR syndrome). However, there are published data showing bipolar vaporization may be associated with increased late complications. In this study, we compared results of bipolar TURP using the resection loop versus vaporization button for treatment of benign prostatic hyperplasia (BPH) to determine the relative safety profle. Patients and methods Between January 2013 and March 2014, 89 patients with BPH were randomized to surgical intervention either by Olympus (Gyrus) Bipolar loop TURP or Olympus (Gyrus) Bipolar button vaporization. Inclusion criteria were; BPH with Q-max<10 ml/s, IPSS >18 and prostate volume>40 g. All patients were evaluated preoperatively and at 1, 3 and 9 months. Evaluation included IPSS, urofowmetry, prostate volume by ultrasound. Clavien complications and operative time were recorded. Statistical analysis was done using Statistical Package of Social Science (SPSS) version 17 software. Results 44 patients were included in bipolar TURP and 45 patients in vaporization arm. Preoperative mean prostate volume (59 g versus 58 g, p=0.52) and mean IPSS (19 versus 20, p=0.38) were equivalent in both groups. Vaporization was associated with a signifcant increase in operative time (mean of 81±15 min range 40–110 versus 55±10 min range 30–70 min, p<0.001), less blood loss (0.8% versus 2.0% drop in hemoglobin, p<0.001) but increased postoperative urinary frequency (80% versus 50%, p<0.001), hematuria with clots up to 4 weeks post surgery (20% versus 2%, p<0.001) and postoperative urethral stricture (11% versus 0%, p<0.001). Both techniques improved urine fow with Q-max (17 ml/s versus 18 ml/s p=0.22). Prostate volume (32 g versus 31 g, p=0.31) and IPSS (6 versus 5, p=0.22), were comparable in both treatment arms. Conclusions Bipolar vaporization of the prostate, despite being a technically robust, speedy and with less intraoperative bleeding, appears to be associated with increased postoperative irritative symptoms, increased late-onset postoperative bleeding and high urethral stricture rates. Keywords Bipolar vaporization · Prostate · Bipolar loop resection · Prospective trial Introduction Benign prostatic enlargement (BPE) is a progressive disease afecting older males and represents a common problem for aging men . It can lead to lower urinary tract symptoms (LUTS) and afects quality of life [2]. Although 
monopolar transurethral resection of the prostate (TURP) is considered the endoscopic gold standard for the surgical 
removal of symptomatic BPE, newer technologies including bipolar resection and bipolar electro-vaporization techniques are increasingly used [3–10]. These bipolar TURP procedures have similar or superior performance characteristics to monopolar TURP [10–13] and adding the benefts of fewer perioperative complications (less blood loss, earlier removal of the catheter and saline irrigation allows more time for removal of large adenoma with negligible 
risk of TUR syndrome) .
Bipolar transurethral resection of prostate technology uses high frequency energy to create a vapor layer
of plasma which contains energy-charged particles that induce tissue disintegration through molecular dissociation. As the active and return electrodes are placed on the same axis of the resectoscope, high current densities are 
achieved locally and distant negative efects reduced .
This technology provides an advantage over the monopolar system in which the energy current passes through the patient’s body, from the active electrode, placed on the resectoscope, toward the return plate placed on the 
patient’s leg, with several disadvantages such as heating of deeper tissue, nerve or muscle stimulation, and possible 
malfunction of the cardiac pacemaker  . Although these are commonly performed procedures, there is little data reporting the relative performance characteristics of bipolar loop resection compared to bipolar vaporization. While bipolar vaporization seems to be slightly less speedy than bipolar resection, vaporization technique is associated with almost no intraoperative bleeding. We endeavored to compare these two approaches, hypothesizing that they would have equivalent performance characteristics.
underwent bipolar plasma vaporization using Olympus Gyrus Button Vaporization system. Inclusion criteria were: BPH with
Q-max < 10 ml/s, IPSS > 18 and prostate volume>40 g. Exclusion criteria were active urinary tract infection, coagulopathy, neurogenic bladder, prostate volume above 80 g, PSA above 4 ng/ml or abnormal DRE, previous urethral stricture or urethral surgery, presence 
of bladder stones or renal impairment. All patients were evaluated preoperatively by history, IPSS and quality of 
life (QoL) questionnaire, physical examination, laboratory investigations, urofowmetry test with residual urine (RU), 
transrectal ultrasound (TRUS) and pelvi-abdominal ultrasound. All patients were followed up at 1, 3, and 9 months
postoperatively by IPSS, urofowmetry and TRUS. Operative time was recorded. All complications in perioperative
period were recorded and classifed according to modifed Clavien system .
Informed written consent was taken from all participants and study protocol was approved from Local ethical committee. All procedures were performed by single surgeon under spinal anesthesia. Surgical protocol starts with urethral dilation up to size 26 French before insertion of the resectoscope. 24 French resectoscope was used in both groups. The procedure was performed via continuous irrigation system using normal saline. The Olympus bipolar generator was set to coagulation at 150 W and cutting at 270 W, doing the standard technique of bipolar resection and vaporization in both groups. At the end of the procedure triple way Foley’s 
catheter, 20 French was placed for 24–48 h postoperatively in all patients, and irrigation with saline was continued till 
urine became clear. Data were collected, tabulated and statistically analyzed using Statistical Package of Social Science
(SPSS) version 17 software. Suitable statistical techniques were computed (frequencies, mean, standard deviation and range).
Results
The study included 44 patients in bipolar TURP group, and 45 in bipolar vaporization group (Table  1). No patient has history of urine retention requiring indwelling catheterization preoperatively. There was no significant age diference in both groups [mean age in group-1 (52.2) and in group-2 (51.7), p = 0.25]. Preoperative prostate volume was similar in both groups (59 g versus 58 g, p = 0.52), and similarly IPSS showed insignifcant difference (19 versus 20, p = 0.38). Vaporization was associated with significant increase in operative time [81.4±15.3 min, range (40–110), versus 55.5±9.8 min, range (30–70), p<0.001], less blood loss (0.8% compared 
to 2% drop in hemoglobin, p<0.001) but increased postoperative urinary frequency (80% versus 50%, p<0.001), hematuria with clots as long as 4 weeks after surgery (20% versus 2%, p<0.001) and postoperative urethral stricture (11% versus 0%, p = <0.001) (Table 1). Postoperatively both techniques improved Q-max (17 ml/s versus 18 ml/s, p = 0.22), postoperative prostate volume measured by 
TRUS (32 g versus 31 g, p=0.31) and IPSS (6 versus 5, p=0.22) equivalently. There was no signifcant diference 
between the two groups regarding improvement in postoperative IPSS, Q-max and prostate volume. Postoperative irritative symptoms (frequency, urgency, and nocturia) were more in vaporization group and improved gradually with
time (80%, 47%, 29%) at 1, 3, and 9 months, respectively (Clavien1). After 6 months postoperatively, fve patients (11%) developed urethral stricture and all were in the vaporization group (three were at bulbomembranous urethra and two at glandular urethra-Clavien3a) (Table 2).
There was no signifcant diference regarding hospital stay (1.3 days versus 1.8 days, p=0.25) or catheterization period (1.5 days versus 1.9 days, p=0.22).

Combined intracavernous vasoactive drugs and sildenafil citrate in treatment of severe erectile
dysfunction not responding to on-demand monotherapy

Osama Abdel-Wahab et al
Abstract Objective: To investigate the effect of chronic use of sildenafil and intracavernous injection (ICI) with trimix in men not responding to on-demand monotherapy with sildenafil or ICI with
prostaglandin-E1 (PGE1).
Patients and methods: The studyincluded 40 patients with erectile dysfunction (ED), with a mean (SD)
age of 50.7 (11.3) years and unresponsive to on-demand sildenafil or ICI with PGE1 as monotherapy.
They were assessed using the Sexual Health in Men (SHIM)-5 score for ED severity, penile colour
Doppler ultrasonography (CDUS) for peak systolic velocity (PSV), end-diastolic velocity (EDV) and
resistance index (RI) with an ICI test using 0.25 mL of trimix of papaverine, PGE1 and phentolamine.
Testosterone, prolactin and cholesterol levels were assessed. Patients received 25 mg sildenafil daily for 8
weeks, combined with twice weekly ICI with 0.25 mL of trimix. After treatment, the Erection Hardness
Score (EHS), penile CDUS with ICI and ED Inventory of Treatment Satisfaction were assessed.
Results: The mean (SD) SHIM-5 score before treatment was 8.3 (0.5) in 15 of the 40 men and 6.3 (0.4)
in 25. Penile haemodynamics were normal in five (13%), showed arterial insufficiency in five (13%),
venous occlusive disease in 26 (65%) and mixed vascular in four (10%). There was an improved
SHIM-5 score in 28 (70%) patients, as shown by their haemodynamic values, duration of erection
and EHS with therapy, and 66% satisfaction with treatment. Adverse effects (penile pain, headache,
facial flushing, dyspepsia, nasal congestion, dizziness) were reported in 17 patients (43%).
Conclusion: Chronic use of trimix plus daily low-dose sildenafil improved penile haemodynamics in
these patients with ED not responding to on-demand phosphodiesterase-5 inhibitors or ICI with
PGE1 monotherapy.
Introduction
The definition of erectile dysfunction (ED) is the persistent
inability to attain and maintain an erection sufficient to permit
satisfactory sexual performance [1]. ED reduces sexual satisfaction and affects partner relationships [2]. A treatment goal
should focus on restoring full sexual functioning, not only improving erection . Erection hardness (EH) is a fundamental component of erectile function and could best define the response to treatment for ED, and can be considered a suitable
assessment . Phosphodiesterase type 5 (PDE-5) inhibitors maintain an erection by inhibiting the catabolism of cGMP,
hence facilitating erection after oral intake, with sexual stimulation required to activate the nitric oxide (NO)-cGMP pathway . In practice, some patients had no or a suboptimal response to PDE-5 inhibitors, and to intracavernous injection
(ICI) of prostaglandin (PG) E1. McMahon et al used the combined therapy of sildenafil plus ICI with triple agents as
salvage therapy for these patients; they used sildenafil up to 100 mg at 1 h before and triple-agent ICI 10 min before
planned sexual intercourse. Park et al evaluated the clinical response and the haemodynamic changes in the cavernous
arteries, and found that combined oral sildenafil and ICI with trimix (papaverine, PGE1 and phentolamine) is the best combination for a pharmacological erection test .Combined therapy with a PDE-5 inhibitor and a second agent that targets another vascular, endocrine or neuronal pathway might provide a possible treatment for patients with
a suboptimal response to ICI with PGE1, or those not responding to on-demand PDE-5 inhibitors. Our treatment goal was based on satisfaction with the quality of erection, by assessing the efficacy of combined chronic therapy with daily low-dose sildenafil citrate and the booster effect of ICI with trimix twice weekly in this selected group of patients with ED .
Patients and methods The study included 23 patients with ED who did not respond to PDE-5 inhibitors, and 17 dissatisfied with their EH after ICI with PGE1, who presented to our sexual dysfunction clinic, referred by other physicians or presented for further evaluation during the period from May 2008 to August 2010. Inclusion criteria comprised patients with ED for P6 months and not responding to previous treatment with PDE-5 inhibitors at maximum dose and ICI with PGE1. Exclusion criteria included hypotension (blood pressure <90/50 mmHg) or uncontrolled hypertension (blood pressure >170/110 mmHg); clinically significant cardiovascular disease in the last 3 months; current or anticipated use of nitrates or NO donors, and known hypersensitivity to or previous severe side-effects from sildenafil. Patients with poor manual dexterity, poor visual acuity, morbid obesity, serious psychiatric and patients with Peyronie’s disease or idiopathic priapism were excluded from study. After a complete history and a physical examination, informed consent for participation was obtained from all patients, and possible risks explained thoroughly according to the Declaration of Helsinki. The option to participate or to abstain from participation was given to the patients; in all, 40 patients agreed to participate in this study. To evaluate their baseline ED, the Sexual Health Inventory for Men (SHIM-5) questionnaire was used at the baseline visit and after 2 months, with threshold scores set as no ED > 22, mild 17–21, moderate 8–16, and severe ED < 7 [9,10]. The questions were preceded by ‘over the past 4 weeks’ and not ‘over the past 6 months’ as in the original version. Laboratory tests included serum testosterone, blood glucose and total cholesterol levels, and a complete blood count. The penile haemodynamics of pharmacologically induced erection in all patients with ED was evaluated with colour Doppler ultrasonography (CDUS), using a Model SSA-350 A system (Toshiba Inc., Tokyo, Japan) at the beginning and repeated after 8 weeks, with measurements of the peak systolic velocity (PSV), end-diastolic velocity (EDV) and resistance index (RI), calculated as (PSV–EDV)/PSV, from the both cavernosal arteries before and after ICI with 0.25 mL of trimix solution (1 mL of the solution contained 18.7 mg papaverine, 6.25 lg PGE1 and 0.62 mg phentolamine) [11]. Readings were registered from the best artery at any time for analysis starting 2–3 min after ICI. Priapism after trimix injection was considered an exclusion criterion from the study. Patients with a normal PSV (P30 cm/s) and normal EDV (P5 cm/s) were classified as having a normal penile blood flow study. ED caused by arterial insufficiency was defined as a PSV of <30 cm/s with normal EDV (P5 cm/s). The diagnosis of veno-occlusive dysfunction (VOD) was defined as a normal PSV (P30 cm/s) with an abnormal EDV (>5 cm/s). Patients who could not be classified into the above categories were defined as having mixed-type ED [12,13]. If there was a successful response after ICI in the clinic, the patient was taught the technique of self-injection and supplied with drugs for home use, but those who had subsequently failed to attend follow-up appointments were excluded. Any other treatments for ED were to be terminated before the study and after a 2-week washout patients received 25 mg sildenafil citrate (Viagra, Pfizer, NY, USA) to be taken not more than once daily for 8 weeks, and ICI with 0.25 mL trimix to be used twice per week. The following drugs were used to constitute the stock solution: Vasorine (each 1 mL containing 30 mg papaverine HCl, Memphis Co., Cairo, Egypt), prostin VR 1 mL containing 500 lg PGE1, (Alprostadil, Pharmacia & Upjohn, USA) and Regitine (1 mL containing 10 mg phentolamine, Novartis Pharma AG, Basel, Switzerland). The ratio of ingredients was 30 mg papaverine: 10 lg PGE1:1 mg phentolamine [11]. Normal saline was used to constitute the doses and the solution was kept at 4 C in a glass container (discarded if not consumed within 30 days). Patients were instructed to attempt sexual activity at least twice each week and to complete an event-log worksheet, and to document compliance the event logs were compared with unused study medication. EH was evaluated subjectively using the EH Score (EHS), a 5-point response score denoting how the patient would rate his erection, with scores of 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not hard enough for penetration), 3 (penis is hard enough for penetration but not completely hard) and 4 (penis is completely hard and fully rigid) [4]. At visit 2 (month 2), satisfaction was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) [14], using the patient version of the EDITS, which includes 11 questions, each scored on a 0–4-point scale, with a higher score indicating greater satisfaction. The mean score of all 11 questions is multiplied by 25 to obtain the EDITS index, resulting in a treatment satisfaction ranging from 0 (lowest satisfaction) to 100 (highest satisfaction). The scores define four levels of satisfaction (i.e. 0–24, not satisfied; 25–49, dissatisfied; 50–74, satisfied; and 75–100, very satisfied). EDITS
scores of >50 indicate satisfaction with treatment [14]. An Arabic translation of the questionnaires (SHIM-5, the EHS
and EDITS) was adopted using the back-translated technique ensuring a functionally equivalent translation and better
understanding of responses to the original versions.
The data were analysed using standard statistical methods, with a one-way anova used to detect variance in variables of
vascular diagnosis, and the Dunnett t (two-sided) post hoc test used to detect differences between patients with arterial insufficiency, VOD and mixed disease vs. normal responders. The Kruskal–Wallis test was used to detect differences between groups in the rigidity response grade 3 and 4. Student’s t-test for paired and unpaired samples was used as appropriate.
For all tests, P < 0.05 was considered to indicate statistical significance and all statistical tests were two-sided.

TUBELESS PERCUTANEOUS NEPHROLITHOTOMY IN SELECTED CASES

Osama Abdel wahab, M.D.,, et al
Abstract:
Objective: To evaluate safety, feasibility and efficacy of tubeless PCNL in supine position in selected cases with renal stones. Material and Methods: This descriptive study enrolled 120 patients presented to urology department Benha faculty of medicine with renal stones from June 2009 to June 2010. All patients were evaluated by history, physical examination, KUB, pelviabdominal U/S, spiral CT abdomen & pelvis without contrast or IVP in selected cases. Patients were followed up for post operative pain, leakage, fever, perinephric collection with U/S, Hb% & hematocrit were done after 12 hours. Results: No significant difference was found in age or stone size. The access to stone was done through lower calyx (70.8%) and middle calyx (29.2%) with stone clearance 100%, there was no need for 2nd session.            Mean operative time was (67.1 ± 19.2), mean hospital stay was (3.4± 1.7). Three cases had perinephric collection < 100cc which were managed conservatively and resolved within one week. Prolonged leakage occurred in three cases and also resolved spontaneously within five days. Three cases need one unit blood transfusion postoperative.Stone free status was achieved in all cases through either lower or middle calyx in supine position. Single dose of NSAID was need in 30 cases as postoperative analgesia Conclusion: Tubeless PCNL with the patients in supine position can be used in selected cases with a favourable outcome and minimal morbidity with the potential advantage of deceased postoperative pain, analgesia requirements and hospital stay. Key words:  Tubeless PCNL, percutaneous nephrostomy, renal stones, percutaneous nephrolithotomy Abbreviations
PCNL: Percutoneous nephrolithotomy.
NSAID: non steroidal anti-inflammatory drugs.
INTRODUCTION
Percutoneous nephrolithotomy (PCNL) is a well – established technique for the treatment of renal stons. Percutaneous nephrolithotomy has replaced open stone surgery for large renal calculi because it is a less minimally invasive tech­nique. The last stage after completion of PCNL is the placement of the nephrostomy tube. The purpose of the nephrostomy tube is to provide hemostasis along the tract, avoid urinary extravasation and maintain adequate drainage of the kidney.1 Placement of a nephrostomy tube after PCNL is considered the standard procedure.2 Several modifications of PCNL have been tried to decrease pain, hospital stay and morbidity. It has been shown that using small caliber nephrostomy tube, miniperc, external stent, tubeless PCNL decreases postoperative pain hospital stay.3 The term tubeless percutaneaus nephrolithotomy was first used by Bellman et al.4 In this study we evaluated safety, feasibility and efficacy of tubeless PCNL in supine position in selected cases. 
METHODS:-
This study included 120 patients presented to urology department Benha faculty of medicine with renal stones from June 2009 to June 2010. Informed written consent was taken from all participants and the study protocol was approved from the research ethical committee of Faculty of Medicine, Benha University. Inclusion criteria were patients with renal stones; stones were removed without residual fragments, no perforation in pelvicalyceal system during PCNL patients with single access. Exclusion critena were patents with stagehorn & complex renal stons, multiple percutaneous tracts (>1), pelvicalyceal system perforation, significant bleeding and/or clinically significant residual fragment at the end of the procedure and bilateral PCNL or PCNL in solitary kidney. All patients were evaluated by history, physical examination, KUB, pelviabd ominal U/S, spiral CT abdomen & pelvis without contrast or IVP in selected cases.
Technique:-  
General anesthesia was used. Retrograde 6 Fr. ureteric catheter was done in ipsilateral side. Patient was positioned in supine position for supine PCNL. All PCNL cases were done in supine position under fluoroscopy. The target calyx entered by puncture needle using Alkan system of dilators till 30Fr. All cases were done through single puncture.  26Fr rigid Nephroscope was used. Fragmentation of the stone was done when needed by pneumatic lithoclast. Finally antigrade pyelography was done in all cases to check the integrity of the collecting system & detect any perforation. Amplatz sheath was removed leaving urethral and ureteric catheter for 24hrs. Patients were followed up for postoperative pain, leakage, fever, perinephric collection with U/S, Hb% & hematocrite were done after 12 hours.
The collected data were tabulated and analyzed using Statistical Package of Social Science (SPSS) version 17 software. Suitable statistical techniques were computed (frequencies, mean, standard deviation & range).
RESULTS
Preoperative patient charactenstics were shown in table (1). No significant difference was found in age or stone size. Stone criteria were shown in table (2). The access to stone was done through lower calyx (70.8%) and middle calyx (29.2%) with stone clearance 100%, there was no need for 2nd session. Operative time, hospital stay, outcome, intra & postoperative complications were listed in table (3). Three cases had perinephric collection < 100cc which were managed conservatively and resolved within one week. Prolonged leakage occurred in three cases and also resolved spontaneously within five days. Three cases needed one unit blood transfusion postoperative due to Hb% & hematocrite drop.
Stone free status was achieved in all cases through either lower or middle calyx in supine position. Ureteric catheter was removed after 24 hours, except in 6 cases (3 cases with prolonged leakage, and 3 cases with perinephric collection discussed before). DISCUSSION
PCNL has revolutionized the management of large renal stones by decreasing the morbidity and reducing the hospital stay when compared with open surgery.5 Valdivia et al, effectively proved that elevation of the desired flank in the supine position enables safe PCNL with low risk of colon injury.6 In this study simple PCNL was done in 120 patients without leaving nephrostomy tube but only ureteric catheter was inserted for 24hrs. The access was through the lower calyx in 85 patients (70.8%) and through the middle calyx in 35 patients (29.2%).
Operation time and hospital stay:
Operative time ranged from (35 – 100min) minutes (67.1 ± 19.2) and hospital stay from 1-7 days with the mean (3.4 ± 1.7). This is in agree with Istanbulluoglu et al, 2 who found operation time in tubeless supine PCNL 51.79 ± 25.23 and hospital stay 2.09 ± 1.75, Also Kara et al, 7.  who found operative time (22 – 50 min). The limitation of this study is the hospital stay which is considered too long at time when Limb and Bellman 8 were reporting a tubeless PCNL using a double- J stent, with a mean duration of hospital stay 1.25 days. We believe that insertion of double –J stent has some disadvantages like urinary tract troubles and need for cystoscopy to remove it which leads to more cost.
Stone free rate: It was 100% in our study, this is in agree with Kara et al, 7 who has stone free rate 96% while Shoma et al, 9 found stone free rate in supine PCNL 89%. While Shah et al, 10 found stone free rate 93.3%.
Postoperative analgesia:
Only 30 patients in this study had single dose of NSAID as postoperative analgesia.This agreed with Shah et al, 10 who had the tubeless PCNL decreased postoperative analgesia requirement and hospital stay.
Postoperative complications: The most common complications of PCNL are hemorrhage and urinary extravasation. Nephrostomy tube placement at the end of standard PCNL is thought to decrease these complications. Despite this, tubeless PCNL retains its role in selected cases.11 Omitting nephrostomy tube placement may expose the patient to significant morbidity and therefore, increase the need for sealing the tract. To date the use of sealing materials remain controversal as studies have failed to demonstrate a significant decrease in urinary extravasation or bleeding.12, 13 In our study there were 3 cases of perinephric collection from 50 – 100 cc which was managed conservatively and resolved spontaneously within 10 days.  
Prolonged leakage also in 3 cases for 5 days, blood transfusion was need for 3 cases due to drop in Hb% and hematocrite value postoperative, this is in agree with Wickham et al, 14 who reported 6% transfusion rate in tubeless PCNL, also Zilberman et al, 15 reported 0 – 11.9% transfusion rate in tubeless PCNL.
Conclusion: Tubeless PCNL with the patients in supine position can be applied in selected cases with a favourable outcome and minimal morbidity with the potential advantage of decreased postoperative pain, analgesia requirements and hospital stay. Acknowledgements:The authors are grateful to colleagues in Urology Department University Hospital, Benha, Egypt for help.Disclosure Statement:No competing financial interests exist.

Antegrade Scrotal Sclerotherapy With and Without Tamoxifen for Treatment of Infertile Men Due to Variocele

Osama Abdelwahab et al

ABSTRACT
INTRODUCTION: The objective was to compare the semen quality and hormonal levels of patients with variocele receiving antegrade scrotal sclerotherapy (ASS) alone versus a combination of ASS and tamoxifen. METHODS: The design was a cross-sectional investigation of 72 patients with varicocele that were surgically managed with ASS. The patients were admitted to the hospital urology department from January to June 2009 with different grades of varicocele and infertility. They were randomly divided into 2 groups: 37 patients underwent ASS only; 35 patients underwent ASS and received tamoxifen citrate 10 mg twice daily, starting immediately after 
ASS and continuing for 6 months. All patients were evaluated preoperatively and postoperatively by history, clinical examination, semen analysis, and Doppler ultrasound. Hormonal assay was indicated in cases of severe oligospermia. Outcome measures were semen parameters and hormonal levels. Operative time, length of hospital stay, length of time before return to normal activity, recurrence rate, and cost of each procedure were also recorded.
RESULTS: The mean (SD) ASS operative time was 20 (6.4) minutes for patients with unilateral varicocele and 28 
(10.8) minutes for patients with bilateral varicocele. The hospital stay for patients with unilateral and bilateral 
surgery was < 24 hours and < 30 hours, respectively. Patients in both groups showed statistically significant improvement in semen count, motility, and abnormal forms 6 months after surgery (P < .001). Over 70% of the patients in both groups had improvement in all 3 measures and there were no significant group differences (P > 
.05). Eleven out of 35 patients in group 2 required hormonal assessment because they had severe oligozoospermia.
There was a significant improvement in hormonal levels following treatment (P < .01). Over 80% of the patients in both groups had no recurrence. Persistent varicocele occurred in 10 patients (13.9%), scrotal hematoma in 5 patients, and postoperative scrotal pain in 1 patient. CONCLUSION: ASS for varicocele in male infertility due to varicocele significantly improves semen parameters with or without tamoxifen. ASS is a rapid, effective, and low-cost procedure. into spermatic veins. If successful, there may be an improvement 
in semen quality in 40-60% of patients and recovery of fertility in 10-40% [3]. Antegrade scrotal sclerotherapy (ASS) 
is performed using local anesthesia because it is minimally invasive and requires patient cooperation to achieve increased 
abdominal pressure while the sclerosing substance is injected . Transcatheter foam sclerotherapy (TCFS) for male varicocele
is associated with a low recurrence rate, high pain resolution rate, and significant improvement in pretreatment sperm 
parameters [5]. Tamoxifen citrate is one of the antiestrogens that has been used extensively for the last 30 years for treatment of 
oligozoospermia, with an average dose of 20 mg/day . Tamoxifen citrate inhibits hypothalamic estrogen receptors and 
causes stimulation of gonadotropin-releasing hormone (GnRH) secretion. As a result, gonadotropin levels increase to stimulate 
Leydig cells and seminiferous tubules]. The purpose of the present study was to compare the semen 
quality and hormonal levels of patients with variocele receiving ASS alone versus a combination of ASS and tamoxifen.
METHODS The study was a cross-sectional investigation of patients with varicocele that were surgically managed with ASS. They 
presented to the Urology Outpatient Clinic of Benha University Hospital between January and June, 2009. The protocol was 
approved by the Research Ethics Committee of the Faculty of Medicine, Benha University. Written informed consent was 
obtained from all participants. Participants The participants were 72 patients with infertility due to varicocele.
Their age range was 22-36 years. Exclusion criteria included patients with azoospermia, subclinical varicocele, 
cryptorchoidism, unilateral orchiedectomy, or known hypersensitivity to contrast media (urografin). 
The patients were randomly assembled into 2 groups, with 37 patients in group 1 and 35 patients in group 2. The mean 
(standard deviation) ages were 27 (3.5) years for group 1 and 28.1 (3.2) years for group 2, with no statistically significant 
group difference. Table 1 contains the baseline type of infertility (primary or secondary), varicocele laterality, and varicocele 
grade for both patient groups (the baseline semen parameters are provided as part of Table 4). Preoperative Evaluation All patients provided a full case history, including personal and fertility information. A physical examination was conducted. 
All patients had 2 seminal analyses and routine laboratory investigations. The patients also received power Doppler 
ultrasound imaging and duplex examination for the spermatic cord and testes. An example is provided in Figure 1. Hormonal 
assessment was completed when indicated; for example, in cases of severe oligospermia (sperm count < 5 million/mL) or evidence 
of impaired sexual function (eg, impotence or low libido). Tests of follicle-stimulating hormone (FSH), testosterone, and 
luteinizing hormone (LH) were done.
Procedures Patients in group 1 underwent ASS only; patients in group 2 underwent ASS and received tamoxifen citrate 10 mg twice 
daily, starting immediately after ASS and continuing for 6 months. All patients were trained to perform a Valsalva 
maneuver. All patients underwent ASS. The patient was placed supine in a slight anti-Trendelenburg position. Deep infiltration of 
local anesthesia (lidocaine 2%) was induced at the scrotal neck (inguinoscrotal area), by injecting 20 mL of a local anesthetic 
into the spermatic cord fascial layers and the surrounding area. The spermatic cord, along with the skin of the scrotum, 
was grasped between the index finger and the thumb. A 1-2 cm incision was made in the scrotal neck (Figure 2). A small 
clamp was drawn underneath the spermatic cord and a rubber band was pulled through it to prevent retrograde flow of 
sclerosant. A suitable vein (ie, large and easily dissectible) of the pampiniform plexus was selected from the dark yellow under fluoroscopic control (Figure 5). This medium was chosen because it was available and less expensive than alternatives. 
The sclerotherapy procedure then began using the air-block technique. The surgeon injected 1 mL of air followed by 3 mL 
of sclerosing agent, during which the patient was instructed to perform a Valsalva maneuver. The increased intraabdominal 
pressure opposes the upward flow of sclerosant into the spermatic vein system. Hence, there is a uniform and capillary 
diffusion into more collateral vessels. The cannula was then removed and the vein ligated proximally and distally using 3-0 
vicryl sutures. Finally, the fascia and skin were closed in layers with 3-0 chromic cat gut sutures. The wound was dressed after 
3-5 minutes of manual compression. Patients were evaluated after 3 and 6 months by clinical examination, Doppler ultrasound, and semen analysis. Hormonal assay was completed in cases of severe oligospermia. 
Data Analysis The outcome measures were the semen parameters of count, motility, and abnormal forms. The pretreatment and 
posttreatment hormonal levels of FSH, LH, and testosterone were compared for patients with severe oligospermia.
The operative time, length of hospital stay, length of time before return to normal activity, recurrence rate, and cost of each 
procedure were also recorded.
RESULTS
No patient required general anesthesia during surgery; 14 patients required sedation in the form of 10 mg diazepam. The 
mean (SD) ASS operative time was 20 (6.4) minutes for patients with unilateral varicocele and 28 (10.8) minutes for patients 
with bilateral varicocele. The hospital stay for patients with unilateral and bilateral surgery was 6-24 hours and 8-30 hours, 
respectively. The patients were able to return to normal activity 3-5 days following unilateral surgery and 5-9 days following 
bilateral surgery, depending on the nature of their activities. 
Intragroup Treatment Comparisons The number of patients in both groups showing improvement 
from presurgery to 6 months postsurgery in semen count, motility, and abnormal forms is contained in Table 2. Patients 
in both groups showed statistically significant improvement in all 3 semen parameters when the presurgery means were 
compared with the 6-month postsurgery means (P < .001). Over 70% of the patients in both groups had improvement in all 3 measures. There were no cases of severe oligozoospermia in group 1. Eleven out of 35 patients in group 2 required hormonal 
assessment because they had severe oligozoospermia (sperm count < 5 million/cc). Table 3 contains the results of the FSH, 
LH, and testosterone hormone tests before surgery and at the 6-month follow-up evaluation. There was a statistically 
significant improvement in all outcome measures following treatment (P < .01). 
There was a significantly larger number of patients with no recurrence of the variocele than with recurrence following 
treatment in both groups (P < .001). In group 1, 33 patients (89.2%) had no recurrence and 4 patients had recurrence; in 
group 2, 29 patients (83%) had no recurrence and 6 patients had recurrence.
Intergroup Treatment Comparisons The mean semen parameters of count, motility, and abnormal forms measured for both groups at the preoperative, 3 month, and 6 month evaluations are contained in Table 4. There was 
no significant difference between the 2 groups on any of the parameters (P > .05). The t values on the table are the result of 
the difference between the 2 means of 2 independent groups. The smaller the difference between the 2 means, the smaller