The treatment of stress incontinence in men: part 2 of a series of articles on incontinence.

BACKGROUND: Stress incontinence in men is a rare, usually iatrogenic condition. Its prevalence can be expected to rise in the future because of the increasingly common performance of radical prostatectomy. Most men who have undergone prostatectomy experience a transient disturbance of urinary continence. Such disturbances are only rarely due to structural damage to the sphincter apparatus and therefore have a good prognosis for spontaneous recovery. METHOD: Selective literature review. RESULTS: Pelvic floor training and/or pharmacotherapy can be used for more rapid restoration of subjectively satisfactory urinary continence. If the sphincter is intact, continence can also be regained in the early postoperative period through the submucosal injection of bulking agents. Incontinent patients whose urinary sphincter is dysfunctional because of denervation or direct injury to striated muscle can now be treated with a variety of surgical techniques. The implantation of an artificial sphincter is the gold standard of therapy. Properly selected and informed patients can also be treated with minimally invasive procedures, such as the creation of a male suburethral sling, although the experience with such procedures to date has not been extensive. CONCLUSION: Post-prostatectomy incontinence has a good prognosis and should thus be treated conservatively at first. If it nonetheless persists, surgical treatment is indicated for patients who choose it after being fully informed about their options.

Management of difficult cases in female urology and neurourology at the Reed M. Nesbit society meeting. Festschrift in honor of Edward J. McGuire, MD.

This is a panel discussion of seven complex urologic cases in female urology and neurourology. Differences in diagnosis and management are discussed by this international panel of experts.

EAU guidelines on neurogenic lower urinary tract dysfunction.

CONTEXT: Most patients with neurogenic lower urinary tract dysfunction (NLUTD) require life-long care to maintain their quality of life (QoL) and to maximise life expectancy. OBJECTIVE: To provide a summary of the 2008 version of the European Association of Urology (EAU) guidelines on NLUTD and to assess the effectiveness of currently available diagnostic tools, particularly ultrasound imaging and urodynamics. EVIDENCE ACQUISITION: The recommendations provided in the 2008 EAU guidelines on NLUTD are based on a review of the literature, using online searches of Medline and other source documents published between 2004 and 2007. A level of evidence and/or a grade of recommendation have been assigned to the guidelines where possible. EVIDENCE SYNTHESIS: NLUTD encompasses a wide spectrum of pathologies, and patients often require life-long, intensive medical care to maximise their life-expectancy and to maintain their QoL. Treatment must be tailored to the needs of the individual patient and, in many cases, involves a multidisciplinary team of experts. Timely diagnosis and treatment are essential if irreversible deterioration of both the upper and lower urinary tracts are to be avoided. Therapeutic decisions are made on the basis of a comprehensive medical assessment, including urodynamics to identify the type of dysfunction. Advances in investigative technologies have facilitated the noninvasive and conservative management of patients who have NLUTD. CONCLUSIONS: The diagnosis and treatment of NLUTD, which is a highly specialised and complex field involving both urology and medicine, requires up-to-date expert advice to be readily available. The current guidelines are designed to fulfil this need.

Trospium chloride and oxybutynin hydrochloride in a german study of adults with urinary urge incontinence: results of a 12-week, multicenter, randomized, double-blind, parallel-group, flexible-dose noninferiority trial.

OBJECTIVES: The aims of this study were to determine whether oral trospium chloride is noninferior to oxy-butynin for urinary urge incontinence and to evaluate its efficacy, tolerability, and health-related quality of life parameters. METHODS: In this randomized, double-blind, active-controlled, parallel-group, multicenter, Phase IIIb trial conducted in Germany, male and female outpatients aged >or=18 years with documented urinary frequency (>or=8 micturitions/24 hours) plus urge incontinence (>or=5 episodes/week) were randomized to receive oral treatment with trospium chloride 15 mg TID or oxybutynin hydrochloride 2.5 mg TID for 12 weeks. Daily doses could be adjusted upward after 4 weeks, to 90 mg of trospium (30 mg TID) and 15 mg of oxybutynin (5 mg TID), respectively, if needed. The absolute reduction in weekly episodes of urinary urge incontinence was evaluated as the primary efficacy variable. Secondary variables included the absolute reduction of micturitions per 24 hours, intensity of urgency, and mean voided volume. Qualitative symptom changes were recorded from the patients' entries in their micturition diaries at baseline, at week 4, and at week 12 of treatment. Subjective treatment outcome was assessed by patient ratings on a visual analog scale (VAS), the King's Health Questionnaire (KHQ), and the 36-Item Medical Outcomes Study Short-Form General Health Survey (SF-36); intensity of dry mouth was also recorded on a scale. Adverse events (AEs) were assessed. RESULTS: Of the 1658 patients treated, 828 patients (49.9%) received trospium 45 mg/d and 830 patients (50.1%) received oxybutynin 7.5 mg/d. After 4 weeks, daily doses were doubled in 29.2% (242/828) of patients in the trospium chloride group, and in 23.3% (193/830) of patients in the oxybutynin group, until the end of treatment. No clinically relevant differences in demographic characteristics were observed between the treatment groups. Trospium was noninferior to oxybutynin hydrochloride in terms of the reduction in the number of weekly urge incontinence episodes after 4 and 12 weeks of treatment. In the per-protocol population, the median change after 12 weeks was -11.0 in both groups. In the full analysis set, the median change was -10.42 with trospium chloride and -10.00 with oxybutynin (P < 0.001 for the noninferiority hypothesis, for both the per-protocol and the full analysis set calculations). There was also no indication of a difference between groups concerning the observed reductions of daily micturitions and intensity of urgency as well as the increase in micturition volume at the end of 12 weeks. VAS, KHQ, and SF-36 scores were improved to a similar extent in both treatment groups at the end of treatment. Worsening of dry mouth was less common in the trospium group than in the oxybutynin group after 4 and 12 weeks (46.9% vs 63.9% and 51.2% vs 64.4%, respectively; bothtime points, P < 0.001 between groups). Treatment-related AEs were reported by 22.7% (188/828) of the trospium chloride group and 26.5% (220/830) of the oxybutynin group. Dry mouth was the most frequently occurring AE, reported by 4.1% (34/828) of patients in the trospium group and 7.7% (64/830) of the oxybutynin group. CONCLUSIONS: Our findings indicate that trospium chloride was noninferior to oxybutynin hydrochloride, both with flexible dosing, over 12 weeks in these patients with urinary urge incontinence. Both drugs were generally well tolerated in the population studied, but fewer patients who received trospium reported worsening of dry mouth than those who received oxybutynin. German Federal Institute for Drugs and Medical Devices Registration Number 4022383.

Propiverine compared to oxybutynin in neurogenic detrusor overactivity--results of a randomized, double-blind, multicenter clinical study.

OBJECTIVES: To compare the efficacy and tolerability of propiverine and oxybutynin in patients with neurogenic detrusor overactivity. METHODS: Patients were eligible, if at least 18 years of age and suffering from neurogenic detrusor overactivity. Eligibility also required a maximum cystometric capacity less than 300 ml. After a one-week run-in period, propiverine 15 mg t.i.d. or oxybutynin 5mg t.i.d. were administered for 21 days. As primary efficacy outcomes urodynamic parameters were assessed. As tolerability outcome the percentage of patients with newly manifesting anticholinergic adverse events was taken. RESULTS: 131 patients were recruited at 20 study centers. The maximum cystometric capacity (ml) was increased significantly in the propiverine group from 198 (+/-110) to 309 (+/-166), and in the oxybutynin group from 164 (+/-64) to 298 (+/-125). Similarly, maximum detrusor pressure during the filling phase (cm H(2)O) was lowered significantly in the propiverine group from 56.8 (+/-36.2) to 37.8 (+/-31.6), and in the oxybutynin group from 68.6 (+/-34.5) to 43.1 (+/-29.2). No significant differences resulted between treatment groups. Anticholinergic adverse events were reported less frequently in the propiverine compared to the oxybutynin group (63.0% versus 77.8%). Dryness of the mouth, the most frequent adverse event, was reported significantly less (47.1% versus 67.2%; p=0.02) in the propiverine compared to the oxybutynin group. CONCLUSION: Propiverine and oxybutynin are equally effective in increasing bladder capacity and lowering bladder pressure in patients with neurogenic detrusor overactivity. The trend for better tolerability of propiverine compared to oxybutynin achieved significance for dryness of the mouth.

Efficacy, tolerability and safety of propiverine hydrochloride in children and adolescents with congenital or traumatic neurogenic detrusor overactivity--a retrospective study.

OBJECTIVES: Anticholinergic treatment combined with intermittent catheterisation is the cornerstone of the conservative treatment strategy in children with neurogenic detrusor overactivity, which in most cases is due to congenital causes. Efficacy, tolerability and safety of propiverine hydrochloride were evaluated retrospectively in these children. METHODS: At four specialized outpatient clinics, all children's records were scrutinized for first-line propiverine hydrochloride treatment, or second- or third-line treatment after failure of a non-selective alpha-blocker (phenoxybenzamine) and/or other anticholinergics (oxybutynin, trospium chloride). The primary efficacy outcomes were urodynamic parameters, with clinical symptoms as secondary outcomes. Statistical analysis was performed by paired t-tests (significance level p < 0.05). RESULTS: Altogether 74 children and adolescents (40 boys, 34 girls; age range 11 months-19 years) were treated with propiverine hydrochloride (average duration 2 years and approximately 4 months; individual dose range 5-75 mg). The primary efficacy outcome parameters improved significantly: maximum cystometric capacity 161.2 [standard deviation (SD) 97.3] to 252.2 ml (SD 117.2), p < 0.001; maximum detrusor pressure 43.8 (SD 39.2) to 27.1 cm H(2)O (SD 26.4), p = 0.002; bladder compliance 7.6 (SD 6.4) to 17.0 ml/cm H(2)O (SD 16.2), p < 0.001. Phasic detrusor overactivity was abolished by 63%; incontinence resolved by 54%. One patient spontaneously reported a typical anticholinergic adverse event, which resolved after dose reduction. No safety concerns were documented. CONCLUSIONS: Propiverine hydrochloride is effective in neurogenic detrusor overactivity in children and adolescents, even in some of those cases unresponsive to other anticholinergics. The low incidence rate (<1.5%) of adverse events evidences a favourable risk-benefit profile of propiverine hydrochloride, considering in particular the total documented treatment and surveillance period of 171 patient years and nine months.

Success of repeat detrusor injections of botulinum a toxin in patients with severe neurogenic detrusor overactivity and incontinence.

OBJECTIVES: Detrusor injections with botulinum toxin type A are an effective treatment for neurogenic detrusor overactivity, lasting for 9-12 months. When the patients develop botulinum resistance, subsequent injections might be less effective. Repeat injections in patients with severe neurogenic detrusor overactivity and incontinence were studied. METHODS: Patients received Botox (300 UI) or Dysport (750 UI) injections. Clinical variables: satisfaction, anticholinergics use, mean and maximum bladder capacity, continence volume. Cystometric parameters: compliance, cystometric capacity, reflex volume. STATISTICS: Anova, chi2-tests; t-tests and paired t-tests (p=0.05). RESULTS: Forty-three men and 23 women (mean age 38.3 years; mean duration of lesion 9.2 years) were included. The interval between subsequent injections (on average 9-11 months) did not change significantly (p=0.5594). The satisfaction was high and anticholinergics use decreased substantially (p=0.0000). Significant improvements were found in clinical parameters and in cystometric capacity, for compliance only at the second treatment. The incidence of reflex contractions was significantly reduced. Four patients had transient adverse events after Dysport. CONCLUSIONS: Repeat injections with botulinum toxin type A are as effective as the first one. The cause for repeat treatment is relapse of overactive bladder symptoms.

European experience of 200 cases treated with botulinum-A toxin injections into the detrusor muscle for urinary incontinence due to neurogenic detrusor overactivity.

OBJECTIVES: To present a comprehensive experience with botulinum-A toxin (BTA) injected into the detrusor muscle in patients with spinal cord injuries/diseases causing neurogenic incontinence. METHODS: Ten European medical centers provided the results of 231 patients with neurogenic detrusor overactivity who were treated with BTA. 300 units of Botox (Allergan Inc.) were injected cystoscopically into the detrusor muscle at 30 different locations, while sparing the trigonum. Urinary continence status, concomitant anticholinergic medication use and patient satisfaction were recorded. Key urodynamic parameters (reflex volume, maximum detrusor pressure during voiding, detrusor compliance and maximum cystometric bladder capacity) at baseline and at the first and second urodynamic follow-up examinations were analyzed. RESULTS: By the time of the initial (mean 12 weeks after injection) as well as at the second urodynamic follow-up examinations (mean 36 weeks after injection), the mean cystometric bladder capacity (p < 0.0001) and the mean reflex volume (p < 0.01) increased significantly, while the mean voiding pressure (p < 0.0001) decreased significantly. The mean bladder compliance had increased significantly (p < 0.0001) by the first follow-up examination and non-significantly by the time of the second follow-up. No injection related complications or toxin related side effects were reported. The patients considerably reduced or even stopped taking anticholinergic drugs without recurrence of reflex incontinence and were satisfied with the treatment. CONCLUSIONS: This retrospective European multicenter study presents the most extensive experience to date with BTA injections into the detrusor muscle to treat neurogenic incontinence due to detrusor overactivity and confirms that this new treatment is safe and valuable. Significant improvement of bladder function corresponds with continence and the subjective satisfaction indicated by the treated patients.

Tamsulosin: efficacy and safety in patients with neurogenic lower urinary tract dysfunction due to suprasacral spinal cord injury.

PURPOSE: We evaluated the efficacy and safety of tamsulosin in patients with neurogenic lower urinary tract dysfunction secondary to suprasacral spinal cord lesions in a 4-week randomized controlled trial (RCT) followed by a 1-year, open label, long-term study. MATERIALS AND METHODS: A total of 263 patients were randomized to 4-week double-blind therapy with placebo, or 0.4 or 0.8 mg tamsulosin once daily. Of these, 244 patients completed the RCT, 186 continued long-term tamsulosin therapy (0.4 or 0.8 mg once daily) and 134 completed 1-year treatment. The primary efficacy parameter was maximum urethral pressure (MUP). RESULTS: Although the mean decrease in MUP at 4 weeks in the RCT did not reach statistical significance over the placebo, it was more pronounced with 0.4 (-12.2 cm H2O or -10%) and 0.8 mg (-9.6 cm H2O or -9%) tamsulosin than placebo (-6.5 cm H2O or -3%). In the long-term study there was a statistically significant mean decrease in MUP (-18.0 cm H2O, p <0.001 or -15%) from baseline to end point. In the long-term study tamsulosin also decreased maximum urethral closure pressure, improved several cystometry parameters related to bladder storage and emptying, and increased to a statistically significantly degree, from baseline to end point, mean voided volume based on the micturition diary. There was statistically significant improvement for the International Prostate Symptom Score Quality of Life, as well as several questions about symptoms related to urinary leakage, and 1 question on bladder emptying and frequency, bother and severity of symptoms of autonomic dysreflexia. Finally, 71% of patients improved according to investigators (44% slightly and 27% much improved). Both doses were effective and well tolerated. CONCLUSIONS: Long-term tamsulosin treatment (0.4 and 0.8 mg once daily) seems to be effective and well tolerated in patients with neurogenic lower urinary tract dysfunction. The results suggest that it improves bladder storage and emptying, and decreases symptoms of autonomic dysreflexia.