Mirabegron versus Solifenacin in Children with Overactive Bladder: Prospective Randomized Single-Blind Controlled Trial.

PURPOSE: The purpose of this study is to investigate the efficacy and safety of mirabegron versus solifenacin in the treatment of newly diagnosed overactive bladder (OAB) in children. METHODS: We conducted a prospective randomized controlled study on pediatric patients with newly diagnosed OAB. Patients were randomized into 3 groups: mirabegron (50 mg once daily) in group I, solifenacin (5 mg) in group II, and placebo in group III. Before starting our treatment and at the end of the 3 months course, we obtained a 3-day voiding diary. This diary included incontinence episode per day, mean voided volume per micturition, mean number of micturition per day, and post-void residual urine. Moreover, the parents/patients were asked to rate symptom relief, and the adverse events were recorded throughout the study period. RESULTS: A total of 190 patients aged from 5 to 14 years completed this study. At the end of this trial, both groups I and II showed significant improvement versus placebo regarding our efficacy parameters with no significant difference between group I and II. The overall success rate based on assessment of symptom relief was significantly higher in the treated groups (87.5% in I and 90.2% in II) versus placebo (55.8%). Dry mouth was reported in 2.8, 10, and 0% and constipation in 2.8, 11.4, and 1.4% in group I, II, and III, respectively, without statistically significant difference between group I and placebo. However, there was a significant difference between group II and placebo regarding these side effects. CONCLUSION: Both mirabegron and solifenacin have comparable efficacy regarding the control of OAB symptoms in the newly diagnosed children, but mirabegrone seems to have less side effects.

Validity of a sponge trainer as a simple training model for percutaneous renal access.

OBJECTIVE: To evaluate the efficacy of our simply designed trainer for junior urologists to acquire the initial skills for percutaneous renal access (PRA). SUBJECTS AND METHODS: Three sponge sheets (60 × 50 × 10 cm) were arranged horizontally over each other. A rectangular groove was made in the middle sheet to accommodate an inflated balloon of a Foley catheter, radio-opaque metal balls, metal rings, or a plastic tube that were sequentially placed for the four training tasks. In each session, 18 trainees were asked to pass a fluoroscopically guided puncture needle from a surface point to the placed object in middle sheet. Clinical impact of training was evaluated by an experience survey on a 5-piont Likert scale (for model usefulness, tactile and fluoroscopic-guidance feedback) and success rate in further mentored practice. RESULTS: There was a gradual increase in tasks' and sessions' scores over the training sessions. According to the experience survey after first clinical practice, the mean (SD) score for overall model usefulness by trainees was 3.8 (0.9) with high fluoroscopic guidance reality [3.6 (1.1)] but poor tactile realism [2.3 (0.9)]. On mentored PRA, the success rate for trainees was 78.3%. CONCLUSION: Our early evaluation showed our novel, cost-effective and reproducible sponge trainer could be an effective training model for PRA with a beneficial impact on subsequent clinical practice.

Evaluation of Percutaneous Tibial Nerve Stimulation for Treatment of Refractory Painful Bladder Syndrome.

OBJECTIVE: To evaluate the efficacy of intermittent percutaneous tibial nerve stimulation (PTNS) as a treatment modality for patients with refractory interstitial cystitis/bladder pain syndrome (IC/BPS). PATIENTS AND METHODS: Twenty female patients with IC/BPS (mean symptom duration of 4.5 ± 2.4 years) each had a 30-minute session of PTNS per week for 12 successive weeks and the symptoms were assessed before, during, and after the treatment sessions by voiding diary, visual analog scale (VAS) for pain, interstitial cystitis symptom and problem indices (ICSI and ICPI), and global response assessment (GRA) scale. The scores of the previous questionnaires were evaluated at weeks 0, 6, and 12. RESULTS: At week 0, the VAS, day time frequency, nocturia, and average voiding volume were 5.6 ± 1.1, 14.5 ± 4.0, 3.0 ± 0.9, and 131.8 ± 35.3 mL, respectively, meanwhile at week 12 these scores were 5.2 ± 1.5, 12.15 ± 3.7, 2.6 ± 0.7, and 141.0 ± 36.2, respectively. There was no statistically significant difference between the scores of the ICPI between weeks 0, 6, and 12 (P = .937). As regards the GRA score after the 12th session, 17 patients (85%) reported having no effect, 1 patient (5%) reported as having worse symptoms, and 2 patients (10%) reported having a mild good response. CONCLUSION: Intermittent PTNS is not a satisfactory treatment for refractory IC/BPS. However, it is recommended to perform more studies with other treatment protocol (maybe closer sessions) to confirm these results.

Simple modification in Hautmann neobladder to carry out left ureteroileal anastmosis without mobilization of the ureter.

We describe a simple modification in Hautmann neobladder that involves an elongation of its left chimney to advance it through the pelvic mesocolon in order to reach the left ureter in its original place. This technique was carried out on 27 patients who had Hautmann pouch after radical cystectomy, and we reported the outcome and complications that occurred at the site of urteteroileal anastomosis in the first 3 years after surgery. The modification was applied easily without any perioperative complications that were related to this step in particular. During follow up of these cases, we lost three patients who died before the end of the third postoperative year. At a mean follow up of 41.3 ± 10.2 months, we have not detected any cases of stricture formation or ureteral recurrence at the sites of the ureteroileal anastmosis. There was only one patient who developed acute pyelonephritis (3.7%) as a result of reflux.

The development of ureteric strictures after ureteroscopic treatment for ureteric calculi: A long-term study at two academic centres.

OBJECTIVE: To determine the incidence of symptomatic and 'silent' obstruction after ureteroscopic procedures. PATIENTS AND METHODS: In all, 1980 patients underwent ureteroscopy for ureteric calculi in two large centres. The methods of disintegration, auxiliary procedures used and type of stenting were considered. Intraoperative complications, in addition to the size and site of the stone, were assessed in relation to postoperative obstruction. The mean (range) follow-up was 42 (12-68) months, with patients assessed after 3-6 months and yearly thereafter. The postoperative evaluation included an assessment of pain, renal ultrasonography, a plain abdominal film, intravenous urography, and a diuretic renal scan in some cases to confirm obstruction. RESULTS: The success rate of stone removal was 98.5%. The failures were related to the size of the stone (>2 cm; P < 0.001). In eight patients there was a ureteric perforation, and six of these developed a ureteric stricture. A stricture also occurred in 12 patients (0.6%) during the follow-up; these included nine of 204 with stones of >2 cm (4.4%), compared to three (0.17%) of 1746 patients with stones of <2 cm (P < 0.001). Fourteen patients presented with pain (0.7%), and five had no obstruction, while in nine (0.46%) the pain was associated with obstruction. There was silent obstruction in three cases (0.15%). The negative and positive predictive values for pain were 99.8% and 64.3%, respectively. CONCLUSIONS: Radiographic surveillance for stricture formation and obstruction is mandatory in patients who are symptomatic after ureteroscopy, and for up to 18 months in patients with intraoperative complications or with a stone of >2 cm in the proximal ureter.

A progressive extended protocol for the basic laparoscopic training using the pelvitrainer.

UNLABELLED: Abstract Purpose: We describe an extended training program using the pelvitrainer to improve the basic laparoscopic skills of the junior urologists. MATERIALS AND METHODS: Ten junior residents were involved in our program that consisted of an hour of training every other day; every 3 hours represented one training session. This curriculum started with 4 inanimate tasks that included peg transfer, disc cutout, extracorporeal, and intracorporeal knot tying. Each task was practiced for one training session with an objective evaluation at the initial attempt and at the end of its session. Thereafter, the participants began to perform an anastomosis using a latex glove model of the laparoscopic urethrovesical anastmosis (L-UVA) (5 experiments). This was followed by 10 experiments of the sheep intestine model of the L-UVA. The performance in these models was evaluated by both the amount of leakage of the injected saline and the time required for completing it. Lastly, another sheep intestine model was performed 3 weeks after the end of the training program. RESULTS: The continuous evaluation of these trainees showed that there was a significant decrease in the time required to perform each of the first 4 tasks at the end of their corresponding sessions compared to the base line values (p=0.000). We also detected a significant decrease in the time and the amount of leakage in sheep intestine models in the 10th attempt compared to the first one (p=0.000). However, there was no significant difference between the results at the 10th model and those of the 3 weeks retest regarding both the time (p=0.198) and the amount of leakage (p=0.076). CONCLUSIONS: The use of the two described models of the L-UVA after the inanimate tasks in the pelvitrainer distributed course of training could help in the improvement and in the retention of the basic laparoscopic skills of the junior urologists.

Combined modality treatment with bladder preservation for muscle invasive bladder cancer.

OBJECTIVE: To evaluate the 5-year results of the following trimodal therapy for treatment of some selected cases of muscle invasive bladder cancer. MATERIALS AND METHODS: In this prospective study, we included 104 patients with transitional cell carcinoma (TCC) (T2 and T3a, N0, M0) who were amenable to complete transurethral resection. All patients received adjuvant chemo-radiotherapy (CRT) in the form of gemcitabine and cisplatin and conventional radiotherapy after the maximum resection of their tumors. Two weeks later, all cases had radiologic and cystoscopic evaluation. The patients who showed no evidence of the bladder tumors [complete response (CR)] went on to complete the CRT, while those with recurrent invasive tumors did not receive any more CRT and were assigned to have salvage cystectomy. Thereafter, all patients were subjected to a regular follow-up. RESULTS: This trimodal therapy was well tolerated in most of cases with no severe acute toxicities. Complete response was achieved in 78.8% of cases after the initial CRT, and tumor grade was found to be the most significant risk factor to predict this response (P = 0.004). With a median follow-up of 71 months for patients with initial CR, 16.2% of cases showed muscle invasive recurrences, and multifocality was the only significant risk factor for their development (P = 0.003). Meanwhile, superficial recurrences were detected in 8.1% of cases with initial CR and were successfully treated with transurethral resection and intravesical bacillus Calmette-Guerin (BCG). On the other hand, we reported distant metastasis in 24.3% of patients with initial CR, and tumor grade, stage and multifocality were the most significant risk factors for this complication (P = 0.002, 0.031, 0.006). No cases of contracted bladder or late gastrointestinal complications were demonstrated in this series. The 5-year overall survival rate for patients with initial CR was 67.6%, and for all the patients in this study it was 59.4%. CONCLUSIONS: This trimodal therapy can be considered as a treatment option for patients with localized muscle invasive TCC. The best candidates for such therapy are those with solitary T2, low grade tumors that are amenable to complete transurethral resection.

Genetic polymorphism of glutathione S-transferases M1 and T1 in Egyptian patients with bilharzial bladder cancer.

OBJECTIVE: To assess the influence of glutathione S-transferases M1 and T1 (GSTM1 and T1) genotype on the risk of bladder cancer in patients with urinary bilharziasis. MATERIALS AND METHODS: This study was designed as a case-control study that involved 60 individuals who were enrolled into 3 equal groups. The first one included patients with bilharzial bladder cancer, the second one had those with nonmalignant urinary bilharziasis, and the last one was the control group. All of the participants were adult males, nonsmokers, and with matched ages. All of them underwent an assessment of the serum level of the total GST concentration and the polymerase chain reaction (PCR) was used for determination of the GSTM1 and T1 genotypes. RESULTS: The lower most GST enzyme concentration was reported in patients with bilharzial bladder cancer (26 +/- 4.4 ng/ml) with significant difference between it and that of the second group (36.8 +/- 4.1 ng/ml, P < 0.05) and that of the controls (40.4 +/- 4 ng/ml, P < 0.005). The PCR results have demonstrated that the frequency of combined GSTM1 and T1 genes deletion (M1-ve T1-ve) was significantly higher in cases of bladder cancer (40%) than those of the controls (5%, P < 0.005) and those of the second group (10%, P < 0.05). The unconditional logistic regression test revealed that patients with urinary bilharziasis and combined GSTM1 and T1 genes deletion are at a significant risk for malignant transformation (OR = 6.3, P < 0.05). CONCLUSIONS: Patients with urinary bilharziasis and GSTM1-ve and T1-ve genes might be at increased risk of bladder cancer. However, larger studies are needed for confirmation of these results.

Endoscopic urethroplasty using small intestinal submucosal patch in cases of recurrent urethral stricture: a preliminary study.

OBJECTIVES: The objective of this study was to evaluate the results of internal urethrotomy with endoscopically placed small intestinal submucosa (SIS) graft for treatment of selected cases of recurrent urethral stricture. PATIENTS AND METHODS: This prospective study included 10 patients with recurrent inflammatory bulbar urethral stricture of 0.5-2 cm in length with no dense spongiofibrosis. Following the 12 o'clock visual internal urethrotomy, a prepared 12F Foley's silicon catheter with the SIS patch was introduced into the urethra over a preplaced super-stiff guidewire. The advancement of this catheter was monitored via a 15F urethroscope to enable us to put its balloon with the overlying SIS patch at the site of the urethral incision. Thereafter, the balloon was inflated with saline and the catheter was secured with a silk suture to the glans. In addition, a suprapubic cystostomy was fixed for bladder drainage. These catheters were kept in place for 2 weeks. The patients were followed up at regular intervals using uroflowmetry and ascending urethrography. RESULTS: At 3-month follow-up, only two cases showed mild recurrent stricture and the rest of cases had a normally patent functional urethra. The subsequent follow-up studies of all the eight successful cases for 12-18 months revealed no evidence of recurrent stricture in all of them and no more interventions were required for any of them. On the other hand, the two cases with recurrent stricture showed a satisfactory response to regular monthly urethral dilatation. CONCLUSION: Endoscopic urethroplasty using SIS patch can be considered as a minimally invasive solution for cases with recurrent, short urethral stricture that are associated with mild spongiofibrosis.

Analysis of risk factors for organic erectile dysfunction in Egyptian patients under the age of 40 years.

Many risk factors have been implicated in the pathogenesis of erectile dysfunction (ED), but it is not clearly evident which of these factors are more relevant among the young population. The aim of this project was to find the most significant risk factors for this disease in young patients. We included 434 patients with organic ED younger than 40 years and 272 age-matched controls. All participants had their complete history taken (including the International Index of Erectile Function-5 [IIEF-5]) and underwent physical examination and some laboratory investigations. Univariate analysis was then applied to study the significance of the following factors in the predisposition of ED: smoking, use of recreational drugs, obesity, dyslipidemia, diabetes mellitus, hypertension, coronary heart disease, and chronic pelvic pain syndrome. This analysis showed that smoking, use of recreational drugs, dyslipidemia, hypertension, and obesity were the significant factors (P < .05 for each factor). When these significant factors were studied in the multivariate model, the only factors that sustained the statistical significance were smoking (P < .05; odds ratio [OR], 1.78; 95% confidence interval [95% CI], 1.16-2.72) and use of recreational drugs (P < .05; OR, 3.18; 95% CI, 1.15-8.82). In addition, a negative correlation was detected between the smoking index of the impotent patients and their IIEF-5 score (r(2) = 0.67; P < .05). In conclusion, smoking and the use of recreational drugs are the most significant risk factors for organic ED in patients younger than 40 years.

Genetic polymorphism of glutathione-S-transferase (GST-M1 and GST-T1) in schistosomiasis -associated bladder cancer in Egyptian patients.

This work was carried out on three groups, 30 Egyptian patients with Schistosoma haematobium (S. haematobium) with bladder cancer (15), and without bladder cancer (15), as well as 15 normal individuals as a control. All the individuals were subjected to measurement of serum level of GST by using ELISA technique and genotyping for GST-M1 & GST-T1 using PCR technique. The results proved that GST serum level was significantly deceased in S. haematobium patients with bladder cancer as compared to the other groups. The PCR results for the GST-M1 & GST-T1 genotyping showed 4 categories, (M1+ve/T1+ve, M1+ve/T1-ve, M1-ve/T1+ve, M1-ve/T1/-ve). There was a significant decrease in enzyme levels in patients with GST-M1-ve/T1-ve as compared to the other categories. Besides, there was a significant increased risk for bladder cancer development in patients with combined gene deletion (OR = 40) which represented mainly in S. haematobium patients with bladder cancer (53.3% = M1-ve/TI-ve).

alpha-Adrenoceptor subtypes in isolated corporal tissue from patients undergoing gender re-assignment.

OBJECTIVE: To investigate the pharmacology and functionality of alpha(1)-adrenoceptors in human corpus cavernosum, and to determine the predominant subtype. MATERIALS AND METHODS: Cavernosal tissue specimens were obtained from the penises of 22 men (mean age 37.4 years) removed during gender re-assignment surgery. The men had been maintained on long-term oestrogen therapy before surgery, to aid the development of secondary feminine characteristics (oestrogen treatments were stopped 6 weeks before surgery). Corpus cavernosum strips were mounted in organ baths perfused with Krebs' solution. A control concentration-response curve (CRC) to phenylephrine (a nonselective alpha(1)-agonist) was obtained. Then the tissues were incubated with the alpha(1A) antagonist, WB4101; the alpha(1B) antagonist, chloroethylclonidine; or the alpha(1D) antagonist BMY 7378 (all at 1 microm) and the CRC to phenylephrine was repeated. The concentration producing a half-maximal response (EC(50)) and pK(B) values (logarithm of the dissociation constant, a measure of affinity) were determined. RESULTS: WB4101 produced a parallel rightward shift of the CRC to phenylephrine, with a pK(B) of 7.49. BMY 7378 also produced a parallel rightward shift of the CRC to phenylephrine with a pK(B) of 6.45. Chloroethylclonidine had a similar effect on the phenylephrine CRC, with a pK(B) of 5.90. CONCLUSION: Alpha(1)-adrenoceptors in human cavernosal tissue have a relatively low affinity for BMY 7378 and chloroethylclonidine, but are more sensitive to WB4101. This confirms that the predominant alpha(1)-adrenoceptor subtype in human corpus cavernosum is the alpha(1A) subtype and this might help in developing more selective antagonists and agonists for managing erectile dysfunction and priapism.