Philippe Grise

Effect of sacral nerve stimulation in patients with fecal and urinary incontinence.

PURPOSE: Preliminary studies have shown improvement in fecal incontinence in several patients who received temporary or permanent stimulation. The purpose of this study was to report our experience in sacral nerve stimulation in the treatment of fecal incontinence and to target patients who would benefit most from stimulation. METHODS: Patients with fecal incontinence were studied clinically and manometrically before, during, and after temporary nerve stimulation. If temporary nerve stimulation was clinically successful, the patient was implanted and followed up for six months. RESULTS: Nine patients (6 female) with a mean age of 50.7 ± 12.3 years underwent temporary nerve stimulation. Temporary nerve stimulation was successful in eight patients, six of whom were implanted. Of the patients who could be evaluated, three of five had improved at the six-month follow-up visit, particularly in relation to the number of urgency episodes and delay in postponing defecation. All implanted patients had urinary symptoms. Urinary urgency was also improved by stimulation. During temporary nerve stimulation, the maximal squeeze pressure amplitude increased. After implantation, only the duration of maximal squeeze pressure seemed to improve. CONCLUSION: Sacral nerve stimulation can be used in the management of fecal incontinence, particularly in cases of urge fecal incontinence associated with urinary urgency. This study seems to confirm the effect of sacral nerve stimulation on striated sphincter function.

Prevention of the Transient Adverse Effects of a Gonadotropin-Releasing Hormone Analogue (Buserelin) in Metastatic Prostatic Carcinoma by Administration of an Antiandrogen (Nilutamide)

Gonadotropin-releasing hormone (GnRH) analogues administered for the treatment of advanced prostatic cancer induce a transient increase in plasma testosterone levels during the first week of treatment, often with a secondary rise in plasma levels of prostatic acid phosphatase and a flareup of disease. To determine whether the antiandrogen nilutamide (Anandron) blocks these effects, we carried out a multicenter, placebo-controlled study of nilutamide in men with prostatic cancer treated with the GnRH analogue buserelin. Thirty-six men with disseminated prostatic cancer and elevated plasma levels of prostatic acid phosphatase were randomly assigned to two groups. Group 1 included 17 men who received buserelin (500 micrograms daily subcutaneously) and nilutamide (300 mg daily by mouth); group 2 included 19 men treated with buserelin and placebo. Symptoms were assessed, and plasma was collected before treatment, daily for 14 days, and on days 18, 22, and 29 after the initiation of treatment. Bone pain appeared or worsened in 5 of the 17 men in group 1 and in 12 of the 19 men in group 2 (P less than 0.05). Acute urinary obstruction occurred in one man in group 2. Despite similar changes in the plasma testosterone levels in both groups, the median concentration of plasma prostatic acid phosphatase decreased almost immediately in group 1, but increased transiently, then decreased on day 14 in group 2. Median levels of prostate-specific antigen decreased immediately in group 1 and decreased on day 8 in group 2. We conclude that nilutamide can prevent the adverse consequences of the buserelin-induced transient rise in plasma testosterone levels in men with advanced prostate cancer treated with a GnRH analogue.

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.

Comprehensive evaluation of bladder and urethral dysfunction symptoms: development and psychometric validation of the Urinary Symptom Profile (USP) questionnaire.

OBJECTIVES To develop and validate a standardized tool assessing urinary symptoms among men and women with stress, urge, frequency, or urinary obstructive symptoms for use in clinical practice to complement clinical measures and diagnosis. METHODS After development by an advisory committee and comprehension testing with patients, the Urinary Symptoms Profile (USP) item content and validity were evaluated by clinicians. Patients with urinary symptoms (n = 253) and without symptoms (n = 75) completed the final questionnaire at day 0 and day 7. Psychometric properties were assessed, including construct and clinical validity, reliability, and predictive ability for detection of and differentiation between urinary disorders. RESULTS Principal Component Analysis with Varimax Rotation confirmed the final USP structure of 13 items in 3 dimensions: stress urinary incontinence (SUI), overactive bladder (OAB), and low stream (LS). Internal consistency reliability (Cronbachs alpha ranging from 0.69 to 0.94) and concurrent validity (Spearman correlation coefficients between International Consultation on Incontinence Questionnaire and SUI and OAB dimensions of 0.73 and 0.62, respectively) were good. Test-retest reproducibility over 7 days was excellent in stable patients (Intraclass Correlation Coefficients from 0.84 to 0.91). USP clinical validity was demonstrated by comparing micturition diary with USP scores. USP dimension scores were excellent predictors of urinary disorder presence and identification. CONCLUSIONS USP is the first valid and reliable questionnaire providing comprehensive evaluation of all urinary disorders and their severity in both men and women with SUI, OAB, and LS. It allows the screening and contributes to the differential diagnosis of these symptoms. The USP is a valuable tool for use in clinical practice.

Treatment of Postprostatectomy Stress Urinary Incontinence Using a Minimally Invasive Adjustable Continence Balloon Device, ProACT: Results of a Preliminary, Multicenter, Pilot Study

OBJECTIVES To evaluate the safety and efficacy of a new minimally invasive device, Adjustable Continence Therapy (ProACT) for patients with postprostatectomy stress urinary incontinence (SUI). METHODS Sixty-two patients with urodynamic SUI after prostate surgery were evaluated according to daily pad count and a specific validated evaluation for persons with urinary incontinence. RESULTS All patients were successfully implanted in a single procedure using general or spinal anaesthesia. Procedural time was 37 minutes (range, 18 to 80 minutes). Daily pad usage decreased from 4.6 pads per day to 1.06 pads per day at 12 months. Mean quality-of-life index score increased from 48 to 67 at 12 months.Fifty-nine percent of patients without adjuvant radiation were improved (greater than 50% reduction in pad use), and 30% were cured (no pads), whereas 83% of postirradiated patients failed intervention. Fifty-five patients (88%) required percutaneous balloon adjustments. The mean optimal volume after adjustments for all 45 improved patients was 3.8 mL per balloon. Complications necessitating removal occurred in 19 patients and included erosion, infection, migration, and failure to respond. Of these, 4 were successfully reimplanted. All complications occurred in the first postoperative month. CONCLUSIONS Implantation of postoperatively adjustable balloons in postprostatecomy men is technically feasible, with an improvement in continence particularly in patients with nonirradiated periurethral tissues. Optimal urethral resistance is achieved, with easy postoperative adjustment. Implantation of ProACT balloons may represent a promising development in the treatment of postprostatectomy SUI.

Nitric Oxide/Cyclic Guanosine Monophosphate Signalling Mediates an Inhibitory Action on Sensory Pathways of the Micturition Reflex in the Rat

BACKGROUND Overactive bladder can be associated with a hyperexcitability of bladder afferent C-fibres. Several studies have suggested that nitric oxide (NO) or its downstream signalling could modulate the micturition reflex (MR) by reducing the excitability of bladder afferents. OBJECTIVES To evaluate the role of the NO/cyclic guanosine monophosphate (cGMP) signalling pathway on the MR in a model of bladder hyperactivity (BHA) associated with C-fibre activation in the rat. DESIGN, SETTING, AND PARTICIPANTS Adult female Sprague Dawley rats were used. MEASUREMENTS Cystometry was performed in anaesthetised rats. The effects of 0.1 mg/kg of sodium nitroprusside (SNP), an NO donor; 10 mg/kg of 8Br-cGMP, a cGMP analogue; 3 mg/kg of sildenafil and 1 mg/kg of vardenafil, two phosphodiesterase type 5 inhibitors (PDE5-I); 10 mg/ml of L-N(G)-nitroarginine methyl ester (L-NAME), an NO synthase inhibitor; and 1 mg/kg of LY-83583, a guanylate cyclase inhibitor, were investigated on BHA during intravesical capsaicin (30 micromol/l) instillation. All drugs were delivered intravenously except for L-NAME, which was intravesically administered. RESULTS AND LIMITATIONS SNP, 8Br-cGMP, and PDE5-I increased the intercontraction interval (ICI), while SNP and PDE5-I increased the micturition pressure threshold (MPT). L-NAME and LY-83583 decreased MPT, and L-NAME decreased ICI. 8Br-cGMP decreased the maximum intravesical pressure (MP), contrary to L-NAME and LY-83583. SNP and PDE5-I had no effect on MP. SNP increased the voided volume (VV). PDE5-I and 8Br-cGMP also increased VV, although not significantly. In contrast, L-NAME tended to decrease VV. Although 8Br-cGMP decreased the baseline intravesical pressure, LY-83583 increased it. Neither SNP nor PDE5-I nor L-NAME had any effect on baseline pressure. CONCLUSIONS Compounds activating the NO/cGMP pathway inhibited BHA, whereas compounds inhibiting the NO/cGMP pathway increased it. These results indicate that the NO/cGMP signalling pathway is involved in the regulation of the MR, with an action that seems more predominant on the sensory rather on the motor component of the MR in a rat model of BHA associated with C-fibre afferent activation.

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 &OV0556; 8525 (95% confidence interval, &OV0556; 6686–&OV0556; 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 &OV0556; 6581 (95% confidence interval, &OV0556; 2077–&OV0556; 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 &OV0556; 94,204 and &OV0556; 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.

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.

Sexual Function After Transobturator Tape Procedure for Stress Urinary Incontinence

OBJECTIVES To assess the effect of the transobturator tape (TOT) procedure for stress urinary incontinence (SUI) on female sexual function. METHODS All women who underwent a TOT outside-in or inside-out procedure for SUI with no concomitant prolapse repair from January 2002 to November 2005 were sent a questionnaire by mail. RESULTS A total of 105 women fulfilled the inclusion criteria, 69 (65.7%) of whom returned the questionnaire. Of these 69 women, 66 (95.6%) agreed to participate in the study, although 4 did not complete the pre or postoperative questionnaire, for a follow-up of 62 women (59.0%). Of the 62 women, 48 were sexually active before and after surgery. No significant differences were found after surgery in the frequency and appreciation of intercourse, extent of sexuality, or the frequency of leakage during intercourse. A nonsignificant decrease of leakage was found after surgery (P = 0.06). Of the 48 women, 15 (31.2%) reported an improvement in intercourse satisfaction and 5 (10.4%) complained of sexual function deterioration after the anti-incontinence procedure. Partner discomfort remained unchanged. Of the 62 patients, 10 (16.1%) were unsatisfied with the surgical outcome because of persistent or recurrence of SUI in 6 and a deterioration of intercourse satisfaction after surgery in 4. CONCLUSIONS These results suggest that TOT procedures for SUI can have a positive, but also a negative, outcome on female sexual function. Additional and larger prospective studies are warranted to support these preliminary findings and to compare sexual function outcomes after transvaginal tape versus TOT procedures for SUI.

Nosocomial Urinary Tract Infections in Urologic Patients: Assessment of a Prospective Surveillance Program Including 10,000 Patients

OBJECTIVE Hospital-acquired urinary tract infections (HUTI) represent a significant impairment in the quality of health care. Incidence in catheterized patients has been estimated at approximately 20%, however few data are available in urologic patients. We report a prospective surveillance program over 6 years in our urologic department and evaluate its evolution. METHODS Population consists of all patients admitted to the urology ward for 48 hours or more over a 6-year period from 1994. Data recorded: age, gender, duration of stay, insertion and removal of catheters, diagnosis of HUTI. ANALYSIS calculation of incidence, and incidence density for HUTI and for catheter-related HUTI, analysis of trends by chi(2) trend test. RESULTS A total of 10,054 consecutive patients were included, 52% were catheterized. The median incidence of catheter-related HUTI in catheterized patients was 13.0%, the incidence density was 25.1 HUTI/1000 patient-days of catheterization. The proportion of HUTI and specific catheter-related HUTI patients decreased, respectively from 8.4% and 14.2% to 6.5% and 12.3% during the study period (p<0.05). CONCLUSION The rate of HUTI was not as high as previously reported, perhaps due to a controlled catheter policy. Surveillance was associated with a significant decrease in infection rates, suggesting a beneficial feedback effect. Evaluation of diagnoses and surgical procedures would ensure an optimal quality control program.