Botulinum Toxin Type A Injection After Failure of Augmentation Enterocystoplasty Performed for Neurogenic Detrusor Overactivity: Preliminary Results of a Salvage Strategy. The ENTEROTOX Study.

OBJECTIVE: To evaluate the clinical efficacy, urodynamic effect and safety of Botulinum Toxin A (BTXA) injections after failure of augmentation enterocystoplasty (AE) performed for neurogenic detrusor overactivity. PATIENTS AND METHODS: We performed a multicenter retrospective study that included patients who had AE and at least one injection of BTXA after AE in 15 GENULF (French Speaking Neuro-Urology Study Group) centers. Clinical and urodynamic data were collected from medical files according to a standardized questionnaire and colligated in an anonymous database. RESULTS: Thirty-three patients with an injection of BTXA after AC in 9 out of 15 centers were included. Mean age at the time of AE was 24 ± 15 years. Overall efficacy (defined by clinical efficacy associated with a request by the patient for reinjection) was observed in 58% of the patients. Mean maximum cystomanometric capacity increased by 28% (333 ± 145 vs 426 ± 131 mL; P = .007) and maximum detrusor pressure (Pdet max) decreased by 43% (44 ± 37 vs 25 ± 18 cm H2O; P = .02) after BTXA. Only one side effect was recorded out of the 152 procedures (transient generalized muscle weakness without respiratory distress). CONCLUSION: In patients with failure after AE performed for neurogenic detrusor overactivity, injection of BTXA in the enlarged bladder was effective in over half of the cases with low morbidity. If this therapeutic approach were confirmed, it could be proposed as an alternative to AE surgical revision.

Neurogenic stress urinary incontinence: is there a place for Adjustable Continence Therapy (ACT™ and ProACT™, Uromedica, Plymouth, MN, USA)? A retrospective multicenter study.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: To assess the effectiveness and complications of treatment for neurogenic stress urinary incontinence (nSUI) by Adjustable Continence Therapy (ACT™ and ProACT™). SETTING: France. METHODS: A retrospective multicentre study of consecutive patients with neurological pathologies treated for nSUI with ACT balloons. RESULTS: From January 2001 to January 2013, 102 patients were implanted. Mean (SD) age at implantation was 48.4 (16.5) years. Patients were followed-up for a mean 2.7 (2.3) years. After implantation, 5.9% of patients were totally continent, 51.2% had an improvement in symptoms of at least 50% (including 14.6% with improvements of at least 90%), and 48.8% had improvements of < 50%, including 7.3% of treatment failures. Complications occurred in 70 patients (120 balloons): 21 balloon infections, 34 migrations, 18 device failures, 28 urethral erosions and 28 cutaneous erosions. The procedure was ineffective for 35 patients. Twenty patients underwent permanent explantation. The rate of migrations was lower in patients with upper motor neuron lesion than in those with lower motor neuron lesion (p = 0.04). CONCLUSIONS: ACT is a minimally invasive treatment for SUI related to sphincter deficiency. This is one of the first reports in a sample of patients with neurological disorders implanted by multiple surgeons. ACT could be a less invasive, appropriate alternative to artificial urinary sphincters. However, it is associated with frequent local complications which are easy to manage but that should be reduced in this challenging population.

The maximum detrusor pressure as a predictive factor of success after sphincterotomy in detrusor-sphincter dyssynergia.

AIMS: To evaluate the impact of the pre-operative maximum detrusor pressure (MDP) on efficacy outcomes after incontinentation by sphincterotomy or urethral stent placement in male patients with neurogenic detrusor-sphincter dyssynergia (DSD). METHODS: A retrospective study was performed in 41 male patients treated between 2006 and 2013 in a tertiary reference center. All patients had a neurogenic DSD confirmed by baseline urodynamic studies, and were unable or secondary failed to practice CISC. Success was defined as a post-void residual volume <150 mL. Influence of MDP on treatment efficacy was evaluated through a Mann-Whitney U-Test. RESULTS: Median (range) age was 39 years (20-69). Spinal cord injury was the main underlying condition. Twenty-six patients had a sphincteric stent placement (Memocath®, Bard, Covington) and 15 had surgical sphincterotomy. Treatment was successful in 31 patients (76%). Patients with immediate successful outcomes had a significantly higher mean preoperative MDP (59.6 vs 29.7 cmH2 O; P = 0.002). Patients with MDP over the threshold of 40 cmH2 O had a 90% success rate. These differences were maintained at 6 months, MDP being higher in the success group than in the failure group (59.5 vs 39.8 cmH2 O, respectively, P = 0.008). The technique used (stent placement or incision) had no impact on immediate or 6-month success rates. CONCLUSIONS: Our results suggested that MDP is associated with treatment success rate after surgical management of DSD of neurogenic origin by sphincteric stent placement or surgical sphincterotomy. A threshold of 40 mH2 O is associated with higher success rates.

Transcorporal artificial urinary sphincter in radiated and non - radiated compromised urethra. Assessment with a minimum 2 year follow-up.

PURPOSE: to assess the efficacy of transcorporal artificial urinary sphincter (AUS) implantation on continence for male stress urinary incontinence in cases of prior surgical treatment or/and radiation failure, and as a first option in radiation patients. MATERIALS AND METHODS: From March 2007 to August 2012, 37 male patients were treated with transcorporal AUS AMS™ 800. Twelve patients had primary placement of transcorporal cuff, a surgical option due to a previous history of radiation and 25 patients had secondary procedure after failure of AUS or urinary incontinence surgery. Functional urinary outcomes were assessed by daily pad use, 24-hour Pad-test and ICIQ-SF questionnaire. Quality of life and satisfaction were assessed based on I-QoL and PGI-I questionnaires. RESULTS: After a median of 32 months, the continence rate (0 to 1 pad) was 69.7%. Median pad test was 17.5g (0-159), mean ICIQ-SF score was 7.3/21 (±5.4) and mean I-QoL score was 93.9/110. A total of 88% of the patients reported satisfaction with the AUS. The 5-year actuarial revision-free for AUS total device was 51%. Patients for primary implant for radiation were not more likely to experience revision than non-radiation patients. Preservation of erections was reported in half of the potent patients. CONCLUSIONS: Transcorporal AUS cuff placement is a useful alternative procedure option for severe male UI treatment, especially in patients with a compromised urethra after prior surgery or radiation. A high continence rate was reported and implantation as first option in radiation patients should be considered.

Transcorporal artificial urinary sphincter in radiated and non - radiated compromised urethra. Assessment with a minimum 2 year follow-up

ABSTRACT Purpose to assess the efficacy of transcorporal artificial urinary sphincter (AUS) implantation on continence for male stress urinary incontinence in cases of prior surgical treatment or/and radiation failure, and as a first option in radiation patients. Materials and Methods From March 2007 to August 2012, 37 male patients were treated with transcorporal AUS AMS™ 800. Twelve patients had primary placement of transcorporal cuff, a surgical option due to a previous history of radiation and 25 patients had secondary procedure after failure of AUS or urinary incontinence surgery. Functional urinary outcomes were assessed by daily pad use, 24-hour Pad-test and ICIQ-SF questionnaire. Quality of life and satisfaction were assessed based on I-QoL and PGI-I questionnaires. Results After a median of 32 months, the continence rate (0 to 1 pad) was 69.7%. Median pad test was 17.5g (0-159), mean ICIQ-SF score was 7.3/21 (±5.4) and mean I-QoL score was 93.9/110. A total of 88% of the patients reported satisfaction with the AUS. The 5-year actuarial revision-free for AUS total device was 51%. Patients for primary implant for radiation were not more likely to experience revision than non-radiation patients. Preservation of erections was reported in half of the potent patients. Conclusions Transcorporal AUS cuff placement is a useful alternative procedure option for severe male UI treatment, especially in patients with a compromised urethra after prior surgery or radiation. A high continence rate was reported and implantation as first option in radiation patients should be considered.

Mirabegron as Add-On Treatment to Solifenacin in Patients with Incontinent Overactive Bladder and an Inadequate Response to Solifenacin Monotherapy: Responder Analyses and Patient-Reported Outcomes from the BESIDE Study [corrected].

PURPOSE: We investigated improvements in overactive bladder and patient reported outcomes in patients with overactive bladder and refractory incontinence treated with mirabegron 50 mg plus solifenacin 5 mg vs solifenacin 5 or 10 mg. MATERIALS AND METHODS: Patients with overactive bladder who were incontinent despite 4 weeks of single-blind daily solifenacin 5 mg were randomized 1:1:1 to a double-blind daily combination of mirabegron 50 mg/solifenacin 5 mg, or solifenacin 5 or 10 mg for 12 weeks. The mirabegron dose was increased from 25 to 50 mg after week 4. Symptom bother, health related quality of life and patient perception of bladder condition were assessed by OAB-q (Overactive Bladder Questionnaire) and the PPBC (Patient Perception of Bladder Condition) questionnaire, respectively. Responder rates were based on a 50% reduction in daily incontinence, zero incontinence episodes and fewer than 8 micturitions per 24 hours with minimal important differences in OAB-q and PPBC. RESULTS: Overall 2,174 patients with a median age of 59 years were randomized, including 727 to the combination, 728 to solifenacin 5 mg and 719 to solifenacin 10 mg. Symptom bother, total health related quality of life and its subscales (coping, concern and social), and PPBC were significantly improved with combination vs solifenacin monotherapy (p <0.05). The odds of achieving clinically meaningful improvements in incontinence, micturition frequency, symptom bother, health related quality of life and PPBC were significantly higher for combination than solifenacin monotherapy. The odds of becoming continent was 47% and 28% higher for combination vs solifenacin 5 and 10 mg (OR 1.47, 95% CI 1.17-1.84, p = 0.001 and OR 1.28; 95% CI 1.02-1.61, p = 0.033, respectively). CONCLUSIONS: Significantly more patients on the combination achieved clinically meaningful improvements in incontinence and micturition frequency. Improvements were accompanied by similar improvements in PPBC, symptom bother and health related quality of life.

How botulinum toxin in neurogenic detrusor overactivity can reduce upper urinary tract damage?

Intradetrusor injections of botulinum toxin are the cornerstone of medical treatment of neurogenic detrusor overactivity. The primary aim of this treatment is to ensure a low pressure regimen in the urinary bladder, but the mechanisms leading to long-term protection of the urinary tract remain poorly understood. In this paper, we highlight the potential benefits of intradetrusor injections of botulinum toxin regarding local effects on the bladder structures, urinary tract infections, stone disease, vesico ureteral reflux, hydronephrosis, renal function based on a comprehensive literature review.

Is benign prostatic obstruction surgery indicated for improving overactive bladder symptoms in men with lower urinary tract symptoms?

PURPOSE OF REVIEW: Lower urinary tract symptoms (LUTS) in men are highly prevalent, and include both storage and voiding symptoms in many cases. The effect of benign prostatic obstruction (BPO) relief on storage symptoms remains unclear. RECENT FINDINGS: The present review summarizes data about the relation between overactive bladder (OAB), voiding symptoms, and urodynamic characteristics in men with LUTS. Pathomechanisms of OAB in a context of BPO are reviewed. Rates of persistent bladder dysfunction after BPO relief are described along with predictive factors of persisting OAB. SUMMARY: OAB is a common clinical feature in a population of male LUTS, often concomitant with voiding symptoms. Although detrusor overactivity is found in some patients with OAB and BPO, there is no absolute correspondence between clinical symptoms and urodynamic findings. In the context of BPO, OAB pathophysiology implicates nitric oxide pathway, bladder ischemia, ageing of the urinary tract, and calcium-activated potassium channels activity. BPO relief can be followed in the medium term by persistence of OAB symptoms, and preoperative detrusor overactivity has been identified as the main predictive factor. However, preoperative urodynamics remain only indicated in specific cases, when it could directly influence clinical decision-making. Antimuscarinics may be the treatment of choice for persistent symptoms after surgery, but there is no firm recommendation in this clinical setting.

Ten year experience of retroperitoneal laparoscopic resection for pheochromocytomas: A dual-centre study of 72 cases.

PURPOSE: To evaluate the safety and efficacy of retroperitoneal laparoscopic resection in patients with pheochromocytoma in a retrospective study. METHODS: Clinical data of patients with adrenal and extra-adrenal pheochromocytomas, operated on between September 1998 and September 2008 at two institutions, including information on patient demographics, surgical procedure, complications and hospital stay were retrieved. RESULTS: Seventy-two retroperitoneal laparoscopic resections were performed (68 patients, 30 males/38 females). Mean age was 51.4 years (15-87 years). Four patients had a bilateral pheochromocytoma. Median BMI was 27 kg/m(2) (interquartile range 23-29). Mean tumour diameter was 4.6 cm (1.3-9). Thirteen patients had a tumour >6 cm. Mean operation time was 110 min (40-210), and median blood loss during surgery was 160 ml (0-1200 ml). Duration of surgery significantly increased with BMI (p = 0.004) and tumour size (p = 0.004). Four patients required conversion to open surgery (two bleeding, one severe adhesion to inferior vena cava and one renal artery aneurysm). Five patients required a blood transfusion with minor postoperative complications in three patients. Major perioperative haemodynamic variations (systolic blood pressure > 180 mmHg, diastolic blood pressure < 70 mmHg) were observed in 54 % of patients, 30 % required postoperative adrenergic drug treatment. The only predictive factor of a perioperative haemodynamic complication was the high level of normetanephrine in the preoperative blood samples. The median postoperative hospital stay was 4.5 days. Blood loss, postoperative complication and postoperative hospital stay did not increase in patients with tumours >6 cm. CONCLUSION: Retroperitoneal laparoscopic surgery for pheochromocytoma is reproducible, safe and effective.

Efficacy of Pelvisoft® Biomesh for cystocele repair: assessment of long-term results

Introduction and Hypothesis To our knowledge a study regarding the efficacy of Pelvisoft® Biomesh for cystocele repair has not previously been reported in the literature. The aim of our study was to assess the long-term efficacy, subjective outcomes and complications in the use of a non-synthetic porcine skin mesh graft (Pelvisoft® Biomesh) associated with transvaginal anterior colporrhaphy in the treatment of cystocele prolapse. Materials and Methods A retrospective study was performed at a single centre. Thirty-three women aged 35-77 years underwent cystocele repair using Pelvisoft® graft between December 2005 and June 2009. Twenty-nine women who underwent transvaginal cystocele repair with Pelvisoft® Biomesh for over a 2 years period were assessed. Four patients were lost to follow-up. Cystocele repair was performed via the vaginal route using Pelvisoft®Biomesh implant by inserting it in the anterior vaginal wall. The median follow-up time was 54.0 months. The rate of recurrence was 17.3%. A total of 6.9% of patients presented early mesh exposure treated by conservative treatment. The mean PFDI-20 score was 72.2. Among sexually active women, the mean PISQ 12 was 33.9 but 56.2% had dyspareunia. After surgery, 6 patients had de novo intercourse. Our results show that the use of Pelvisoft® biomaterial associated with anterior colporrhaphy for cystocele repair appears to be safe with acceptable failure and complication rates at long term. Nevertheless, an adverse impact on sexual function was reported by the majority of patients. .

Efficacy of Pelvisoft® Biomesh for cystocele repair: assessment of long-term results.

INTRODUCTION AND HYPOTHESIS: To our knowledge a study regarding the efficacy of Pelvisoft® Biomesh for cystocele repair has not previously been reported in the literature. The aim of our study was to assess the long-term efficacy, subjective outcomes and complications in the use of a non-synthetic porcine skin mesh graft (Pelvisoft® Biomesh) associated with transvaginal anterior colporrhaphy in the treatment of cystocele prolapse. MATERIALS AND METHODS: A retrospective study was performed at a single centre. Thirty-three women aged 35-77 years underwent cystocele repair using Pelvisoft® graft between December 2005 and June 2009. Twenty-nine women who underwent transvaginal cystocele repair with Pelvisoft® Biomesh for over a 2 years period were assessed. Four patients were lost to follow-up. Cystocele repair was performed via the vaginal route using Pelvisoft® Biomesh implant by inserting it in the anterior vaginal wall. RESULTS: The median follow-up time was 54.0 months. The rate of recurrence was 17.3%. A total of 6.9% of patients presented early mesh exposure treated by conservative treatment. The mean PFDI-20 score was 72.2. Among sexually active women, the mean PISQ 12 was 33.9 but 56.2% had dyspareunia. After surgery, 6 patients had de novo intercourse. CONCLUSIONS: Our results show that the use of Pelvisoft® biomaterial associated with anterior colporrhaphy for cystocele repair appears to be safe with acceptable failure and complication rates at long term. Nevertheless, an adverse impact on sexual function was reported by the majority of patients.

[The nurse and urodynamic testing in the framework of cooperation between professionals]. / L'infirmière et le bilan urodynamique dans le cadre des coopérations.

Two expert nurses can now carry out urodynamic testing in accordance with a protocol of cooperation between health professionals signed last November. The urology department of Rouen University Hospital is thereby validating two years of work and is fully in line with the framework of the hospital, patients, health and territories law. An account of a process which serves as a model.

Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study.

BACKGROUND: In the treatment of patients with idiopathic overactive bladder (iOAB), high doses of botulinum toxin type A (BoNTA) were often associated with complications resulting from high postvoid residuals (PVR), leading to clean intermittent catheterisation (CIC) and urinary tract infections (UTI). OBJECTIVE: Evaluate the efficacy and tolerability of low doses of onabotulinumtoxinA compared to placebo in patients with iOAB. DESIGN, SETTING, AND PARTICIPANTS: Between 2005 and 2009, adults with persistent iOAB were included in a prospective, randomised, double-blind, placebo-controlled comparative trial. INTERVENTION: Patients were randomised to undergo a single intradetrusor injection procedure of either placebo or onabotulinumtoxinA (50 U, 100 U or 150 U). MEASUREMENTS: The initial evaluations (ie, clinical and urodynamic variables as well as quality of life [QoL]) were repeated at day 8 and months 1, 3, 5, and 6. RESULTS AND LIMITATIONS: Ninety-nine patients were included in the efficacy analysis. Three months after the procedure, we observed>50% improvement versus baseline in urgency and urge urinary incontinence (UUI) in 65% and 56% of patients who respectively received 100 U (p=0.086) and 150 U (p=0.261) BoNTA injections and >75% improvement in 40% of patients of both groups (100 U [p=0.058] and 150 U [p=0.022]). Complete continence was observed in 55% and 50% patients after 100 U and 150 U BoNTA treatment, respectively, at month 3. Frequency symptoms and QoL improved up to the 6-mo visit. We observed only three patients with a PVR>200 ml in the 150 U group and a few UTIs. CONCLUSIONS: 100 U and 150 U BoNTA injections were well tolerated and have both shown to improve symptoms and QoL in patients with iOAB. Nevertheless, 100 U injections showed a reasonable efficacy, with a lower risk of high PVR. TRIAL REGISTRATION: ClinicalTrials.gov NCT00231491.

Can sacral neuromodulation improve minor incontinence symptoms in doubly incontinent patients successfully treated for major incontinence symptoms?

OBJECTIVE: To describe the effect of sacral nerve modulation (SNM) on less severe types of incontinence in patients who were successfully implanted for either urinary or fecal incontinence, and who presented with double incontinence. When conservative treatments fail, SNM is a first-line treatment for patients with urge urinary or fecal incontinence. METHODS: All patients who received SNM between 2005 and 2010 at 5 hospitals and who still had the implant were included in our survey. All received a urinary and fecal change and quality of life questionnaire by mail to complete. RESULTS: Of the 51 questionnaires sent out, 37 were returned, for a 72.5% response rate. The population was composed of 97.3% women, with a mean age of 56.8 years (SD 14). The main indication for SNM was urge urinary incontinence in 15 patients (40.5%) and fecal incontinence in 22 patients (59.5%). Eighteen patients (48.7%) had improvements in both urinary and fecal incontinence symptoms. The percentage increased to 53.3% (16/30) in the group of patients with urge urinary incontinence associated with fecal incontinence. Patients who reported an improvement in double incontinence symptoms complained more often of urge urinary incontinence than other patients (P=.04). CONCLUSIONS: Of the doubly incontinent patients who were successfully implanted for a predominant type of incontinence (ie, urinary or fecal incontinence), 48.7% had an improvement in the other type of incontinence. Patients with urge urinary incontinence associated with fecal incontinence were more likely to report an improvement in double incontinence than the other patients.

I-STOP TOMS transobturator male sling, a minimally invasive treatment for post-prostatectomy incontinence: continence improvement and tolerability.

OBJECTIVE: To prospectively evaluate the efficacy and tolerability of the I-STOP TOMS transobturator male sling in patients with post-prostatectomy stress urinary incontinence. Minimally invasive techniques, such as slings, are becoming the standard of care for mild to moderate post-prostatectomy incontinence. METHODS: From March 2007 to June 2009, 122 patients with post-prostatectomy stress urinary incontinence were treated with the I-STOP TOMS sling and followed up for 1 year in the Phase IV HOMme INContinence trial. The preoperative and postoperative evaluation included daily pad use, pad test, questionnaires evaluating urinary function and bother (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) and uroflowmetry, including the post-void residual urine volume. Patient satisfaction and perineal pain were also assessed. RESULTS: A total of 103 patients were followed up for 12 months. The surgical procedure was considered easy to perform. The mean daily pad use decreased significantly from 2.4 to 0.6 at 12 months of follow-up; 87.0% of the patients reported improved continence (59.4% completely dry, 20.3% 1 pad/d, 7.3%>1 pad/d), and 13.0% reported no improvement. All quality-of-life scores (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) improved significantly after sling implantation. Treatment satisfaction was >90%. The post-void residual urine volume did not increase substantially, and acute urinary retention did not occur. The perineal pain scores were very low at follow-up. Wound infection was seen in 2 patients at the 1-month follow-up visit. CONCLUSION: The I-STOP TOMS is a good treatment option for patients with post-prostatectomy stress urinary incontinence. With follow-up≤12 months, most patients were continent or had improved continence. The intervention was well tolerated, with few infections.

Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

Quality of life in adults with bladder exstrophy-epispadias complex.

PURPOSE: We evaluated quality of life in adults with bladder exstrophy-epispadias complex to improve patient and parent counseling. MATERIALS AND METHODS: We evaluated quality of life in a multicenter study using the SF-36® Medical Outcome Study questionnaire and a local questionnaire. A total of 47 patients born in 1957 to 1990 were followed due to bladder exstrophy-epispadias complex at the 4 participating hospitals. RESULTS: Nine women and 16 men were included in analysis, including 15 who underwent staged reconstruction for bladder exstrophy-epispadias complex and 10 who underwent primary or secondary urinary diversion. Nine patients were married and 2 were in a long-term partnership. A total of 22 patients achieved a high school degree with examination success and 17 worked full time. Six women and 12 men achieved penetrative intercourse. A total of 13 children were born to 3 women and 7 men. Quality of life scores in our patients were less than the norm based scores on 2 of the 8 health concepts, including limitations in physical activity due to health problems and general health perception. Results were statistically different among patients depending on dryness, voiding and urinary reconstruction/diversion. Patient scores did not differ in regard to gender, number of interventions, sexual life, cosmesis or renal function. CONCLUSIONS: Patient scores were less than norm based scores on only 2 health concepts and patients were generally well integrated into society. Urinary diversion was usually well tolerated. It remains a therapeutic option when incontinence interferes with social life or renal function is compromised.

Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses.

BACKGROUND: Botulinum toxin type A (BoNTA) has been reported to be effective for treatment of patients with neurogenic detrusor overactivity (NDO) refractory to anticholinergic agents. However, in most of the studies, the efficacy was associated with concomitant use of anticholinergics. OBJECTIVE: To evaluate the efficacy and tolerability of BoNTA and compare two different doses in patients with NDO without concomitant anticholinergics. DESIGN, SETTING, AND PARTICIPANTS: Between 2004 and 2006, adults with NDO refractory to anticholinergics or discontinued anticholinergics due to adverse events or contraindications from four different French clinical centres were included in a prospective, randomised, double-blind, comparative trial. Inclusion criteria were urinary incontinence (UI) resulting from NDO that could not be managed with anticholinergics. Patients with bladder cancer, lithiasis, or urinary infection were excluded. INTERVENTION: Patients were randomised to receive an intradetrusor injection of 500 U or 750 U of BoNTA. MEASUREMENTS: The initial evaluation (ie, clinical and urodynamic variables and quality of life [QoL]) was repeated at days 30, 90, 180, and 360. Primary outcome was complete continence rate at day 30. Secondary outcomes were cumulative incontinence rate, reappearance of leakages, pad usage, urodynamics, and QoL. RESULTS AND LIMITATIONS: Seventy-seven patients received 500 U (n=39) or 750 U (n=38) of BoNTA and were included in the full analysis set for efficacy analysis. Complete continence at day 30 was observed in 22 patients (56.4%) and 28 patients (73.7%) receiving 500 U or 750 U of BoNTA, respectively (p=0.056; one-sided χ(2) test to compare to α=0.025). The median delay in the reappearance of leakages was 168 d. Monotherapy of BoNTA significantly improved UI in patients with NDO. Although there was a trend towards a greater improvement with 750 U of BoNTA, no statistically significant differences in terms of clinical and urodynamic variables and QoL were found between the treatment groups. Tolerability was excellent and equivalent for both doses. CONCLUSIONS: Monotherapy of BoNTA at Dysport (Ipsen, Brisbane, CA, USA) doses of 500 U or 750 U seems to be effective and well tolerated in patients with NDO.