Determining patient preferences in the treatment of medication-refractory overactive bladder.

INTRODUCTION: Overactive bladder (OAB) is often suboptimally addressed by behavioral or pharmacological treatments. Less than 15% of patients choose to pursue advanced OAB therapy (sacral nerve stimulation [SNS], percutaneous tibial nerve stimulation [PTNS], and bladder onabotulinum toxin type-A [BTX-A]). We seek to better understand which factors are most important to patients when choosing a third-line therapy. METHODS/MATERIALS: We developed a conjoint analysis survey that included five attributes of the third-line options for OAB (SNS, PTNS, and BTX-A). We administered the survey to new patients with urinary incontinence at two institutions. A hierarchical Bayes random effects regression analysis was used to determine the relative importance of the attributes. A choice simulator was used to model which third-line treatment options patients preferred. We followed patients to see if they pursued their predicted treatment. RESULTS: A total of 108 patients completed the study of whom 89% were women. There was representation from all age groups. The most important attributes of decision-making were the frequency of future procedures, the risk of catheterization, and the need for a device. On market simulation, SNS was the preferred treatment option (47%), followed by PTNS (29%) and BTX-A (14%). Only 10% of patients did not find any treatment option acceptable. CONCLUSIONS: Frequent follow-up, risk of catheterization, and the need for a device were the most important attributes when making a decision on third-line OAB therapy. On market simulation, SNS is the preferred treatment for all age groups though the ultimate choice in third-line therapy may be affected by external factors.

Aquablation Treatment for Benign Prostate Hyperplasia: Current Standardized Procedure.

The following video Atlas summary reviews all technical elements of the standardized setup, robotic execution, aquablation procedure, and hemostasis for efficient rapid benign prostate hyperplasia treatment.

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented. METHODS: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented. RESULTS: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred. CONCLUSIONS: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

Sacral Nerve Stimulation in Parkinson's Disease Patients With Overactive Bladder Symptoms.

OBJECTIVE: To assess the efficacy, safety, and outcomes of sacral nerve stimulation (SNS) for Parkinson's disease (PD) patients with overactive bladder symptoms. METHODS: We retrospectively reviewed PD patients who underwent Stage I SNS. Demographics, urodynamic data, and baseline voiding function were analyzed. Efficacy and safety of treatment were determined by rate of progression to Stage II, explantation, and surgical revision. Long-term outcomes were assessed using voiding diaries and/or clinic notes. RESULTS: Sixty percent (9/15) experienced ≥50% improvement in urinary parameters and proceeded to Stage II. There was no significant difference in age, body mass index, comorbidities, PD disease duration, or levodopa equivalent daily dose between successful and nonsuccessful Stage I patients. However, 100% of female patients experienced Stage I success compared to 44% of male PD patients (P = .04). Individuals with >12-month follow-up experienced an average reduction of 6 voids/day. No patients required revision or explantation of their device at latest clinic follow-up (22.2 ± 7.8 months). Higher maximal urethral closure pressures, detrusor pressure at maximum flow rate (PdetQmax), post-void residual volume, and mean bladder outlet obstruction index were observed in the Stage I trial failures. CONCLUSION: At our institution, PD patients have a similar rate of progression to Stage II compared to the general population. SNS is an effective therapy that should be considered among the treatment options for PD patients with overactive bladder symptoms. Urodynamic parameters associated with obstruction may be predictive of SNS failure in PD patients and may help guide patient selection, however further studies are needed.

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented. METHODS: A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants. RESULTS: At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events. CONCLUSIONS: The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

Statewide Success of Staged Sacral Neuromodulation for the Treatment of Urinary Complaints in California (2005-2011).

PURPOSE: Sacral neuromodulation (SNS) is approved by the Food and Drug Administration as a third-line treatment for refractory overactive bladder, idiopathic urinary retention, and fecal incontinence. Prior to implantation of an implantable pulse generator, all patients undergo a trial phase to ensure symptom improvement. The published success rates of progression from the test phase to permanent implant vary widely (range, 24% to >90%). We sought to characterize success rates using a statewide registry. METHODS: Using nonpublic data, we identified SNS procedures using the California Office of Statewide Planning and Development ambulatory surgery database from 2005 to 2011. A successful trial was defined as receiving a stage 2 generator implantation after trial lead placement. Multivariable logistic regression was performed to identify factors associated with staged success. RESULTS: During the study period, 1396 patients underwent a staged SNS procedure, with 962 (69%) subsequently undergoing generator placement. Successful trial rates were 72% for overactive bladder wet, 69% for urgency/frequency, 68% for interstitial cystitis, 67% for neurogenic bladder, and 57% for urinary retention. On multivariate logistic regression, only male sex (odds ratio, 0.51) and urinary retention [odds ratio, 0.54) were significantly associated with lower odds of success, whereas age, race/ethnicity, medical insurance, and placement at an academic or high-volume institution had no association. CONCLUSIONS: The "real world" success rates for staged SNS implantation in California are less than those observed by some academic centers of excellence but better than previously reported for Medicare beneficiaries. Successful trial rates for interstitial cystitis and neurogenic voiding dysfunction are similar to refractory overactive bladder.

The mechanical stop test and isovolumetric detrusor contractile reserve are associated with immediate spontaneous voiding after transurethral resection of prostate.

PURPOSE: To identify urodynamic factors associated with the mechanical stop test and immediate spontaneous voiding following transurethral resection of prostate (TURP). METHODS: We identified 90 men who underwent TURP over a 12-month period. Forty-three (mean age 68 years) underwent urodynamic evaluation prior to TURP. Isovolumetric detrusor contractile pressure (Piso) was obtained using the mechanical stop test during the voiding phase, and used to calculate detrusor contractile reserve (Pres = Piso - Pdet@Qmax). Primary outcome was spontaneous voiding after TURP. RESULTS: Preoperative catheter-free spontaneous voiding was present in 63% of men (27/43) with a urodynamic (mean ± SD): Qmax 6.2 ± 2.7 mL/s, Pdet@Qmax 102 ± 47 cmH2O, Piso 124 ± 49 cmH2O, Pres 22 ± 16 cmH2O, bladder outlet obstruction index (BOOI) 90 ± 49, and bladder contractility index (BCI) 132 ± 44. The remaining 16 catheter-dependent men demonstrated a urodynamic (mean ± SD): Qmax 3.6 ± 3.3 mL/s, Pdet@Qmax 87 ± 38 cmH2O, Piso 99 ± 51 cmH2O, Pres 10 ± 18 cmH2O, BOOI 82 ± 36, and BCI 106 ± 48. Following TURP, 67% of men voided spontaneously with their first void trial, and in receiver operator analysis of urodynamic measures (Pdet@Qmax, Piso, Pres, BOOI and BCI), only Pres was significantly associated with immediate spontaneous voiding after TURP (threshold Pres ≥ 9 cmH2O, AUC = 0.681, p = 0.035). CONCLUSIONS: In men who underwent TURP, a Pres ≥ 9 cmH2O was associated with immediate spontaneous voiding and may be easily incorporated into the postoperative pathway.

To stage or not to stage?-A cost minimization analysis of sacral neuromodulation placement strategies.

AIMS: Sacral neuromodulation (SNM) is a standard therapy for refractory overactive bladder (OAB). Traditionally, SNM placement involves placement of an S3 lead with 1-3 weeks of testing before considering a permanent implant. Given the potential risk of bacterial contamination during testing and high success rates published by some experts, we compared the costs of traditional 2-stage against single-stage SNM placement for OAB. METHODS: We performed a cost minimization analysis using published data on 2-stage SNM success rates, SNM infection rates, and direct reimbursements from Medicare for 2017. We compared the costs associated with a 2-stage vs single-stage approach. We performed sensitivity analyses of the primary variables listed above to assess where threshold values occurred and used separate models for freestanding ambulatory surgery centers (ASC) and outpatient hospital departments (OHD). RESULTS: Based on published literature, our base case assumed a 69% SNM success rate, a 5% 2-stage approach infection rate, a 1.7% single-stage approach infection rate, and removal of 50% of non-working single-stage SNMs. In both ASC ($17 613 vs $18 194) and OHD ($19 832 vs $21 181) settings, single-stage SNM placement was less costly than 2-stage placement. The minimum SNM success rates to achieve savings with a single-stage approach occur at 65.4% and 61.3% for ASC and OHD, respectively. CONCLUSIONS: Using Medicare reimbursement, single-stage SNM placement is likely to be less costly than 2-stage placement for most practitioners. The savings are tied to SNM success rates and reimbursement rates, with reduced costs up to $5014 per case in centers of excellence (≥ 90% success).

Outcomes of Sacral Nerve Stimulation for Treatment of Refractory Overactive Bladder Among Octogenarians.

OBJECTIVE: Sacral nerve stimulation (SNS) is an effective treatment for refractory overactive bladder (OAB). However, advanced age is often cited as a reason to avoid SNS in the elderly. This study evaluates the safety and efficacy of SNS for refractory OAB among our octogenarian population. METHODS: A retrospective review from a single institution was performed on all SNS lead placements from December 1998 to June 2017 for refractory OAB. Octogenarians were characterized as 80 years of age or older at the time of Stage I. Efficacy and safety were determined by the rate of progression to Stage II, subsequent need for multimodal therapy, and rate of surgical revision and explantation. All patients were followed for a minimum of 12 months. RESULTS: Of 374 patients in this study, 37 (9.9%) were octogenarians. There was no difference in gender, race, smoking history, or prior OAB treatment regimens between cohorts. The rate of progression to Stage II was 56.8% for octogenarians compared to 60.5% for nonoctogenarians (p = 0.66). The rate of surgical revision, explantation, and need for multimodal therapy did not differ between groups. Subgroup analysis of octogenarians did not reveal any significant differences between successful and nonsuccessful Stage I patients. CONCLUSIONS: The safety and efficacy of SNS was similar between cohorts. This result suggests that SNS is a safe and effective therapy that should be considered among the treatment options for refractory OAB in octogenarian patients. Further studies are needed to determine predictive factors of Stage I success in elderly patients.

First-in-human implantation of a mid-field powered neurostimulator at the sacral nerve: Results from an acute study.

INTRODUCTION: Commercially approved implantable systems for sacral neuromodulation require the implantation of a multipolar lead subcutaneously connected to an implantable pulse generator (IPG). Eliminating the need for an IPG would eliminate the need for tunneling of the lead, reduce procedure time, infection risk, and the need for IPG replacement. The objective was to demonstrate the feasibility of implanting the AHLeveeS System in the S3 Foramen to stimulate the S3 sacral nerve. MATERIALS AND METHODS: A first-in-human, prospective, single center, nonrandomized, acute feasibility clinical investigation at the Maastricht University Medical Center+. Patients with refractory overactive bladder underwent acute implantation of the AHLeveeS neurostimulator before the InterStim procedure. Outcome measurements included motor responses, procedural time and a scoring of the difficulty of the implant and explant procedure. Retrospectively, qualitative responses to the stimulation protocol were assessed by video motion analyses. Only descriptive statistics were used. RESULTS: During the stimulation a motor response to stimulation was seen in four of the five subjects. In all implantations the AHLeveeS was correctly placed. The median time for complete procedure was 24 minutes. The implant and explant procedures were successfully performed and no device or procedure related adverse events occurred. CONCLUSIONS: The results from this acute first-in-human study demonstrate the feasibility of implantation and acute stimulation of the sacral nerve with this mid-field powered system. Future clinical studies will focus on safety and efficacy of a chronically implanted device.

Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation.

PURPOSE: We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim™ implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency-frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried. MATERIALS AND METHODS: Therapeutic success was defined as a urinary urge incontinence or urgency-frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ-OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events. RESULTS: Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean ± SD of 3.1 ± 2.7 leaks per day and 189 with urgency-frequency had a mean of 12.6 ± 4.5 voids per day. The 5-year therapeutic success rate was 67% (95% CI 60-74) using modified completers analysis and 82% (95% CI 76-88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 ± 2.2 leaks per day and subjects with urgency-frequency had a mean reduction of 5.4 ± 4.3 voids per day (each completers analysis p <0.0001). Subjects showed improvement in all ICIQ-OABqol measures (p <0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%). CONCLUSIONS: This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.

Three-year Follow-up Results of a Prospective, Multicenter Study in Overactive Bladder Subjects Treated With Sacral Neuromodulation.

OBJECTIVE: To evaluate the therapeutic success rate, and changes in quality of life (QOL) and safety in subjects using sacral neuromodulation (InterStim System) at 36 months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) and/or urgency frequency (UF), who had failed at least 1 anticholinergic medication, and had at least 1 untried medication were included. METHODS: Subjects with successful test stimulation received an InterStim implant. Therapeutic success and quality of life through 36 months was evaluated in implanted subjects with data at baseline and follow-up. Safety was evaluated using reported adverse events. RESULTS: A total of 340 subjects received test stimulation resulting in 272 implanted subjects. Demographics include 91% female, mean age of 57 years, and baseline symptom severity of 3.1 ± 2.7 leaks/day (UI) and 12.6 ± 4.5 voids/day (UF). The analysis showed an OAB therapeutic success rate of 83% (95% confidence interval: 78%-88%). UI subjects had a mean reduction from baseline of 2.3 ± 2.3 leaks/day whereas UF subjects had a mean reduction of 5.3 ± 4.0 voids/day (both P < .0001). Statistically significant improvements were observed in all measures of the International Consultation on Incontinence Modular Questionnaire-OABqol (all P < .0001). Eighty percent of subjects reported improvements in their urinary symptom interference. Device-related adverse events occurred in 47% (127/272) of subjects post-implant; 91% were resolved at the time of this analysis. CONCLUSION: The 36-month follow-up data from the multicenter study demonstrate sustained safety, effectiveness, and improved QOL in subjects implanted with InterStim, without requiring failure of all medications.

The effect of angiotensin inhibition on urinary incontinence: data from the National Health and Nutrition Examination Survey (2001-2008).

INTRODUCTION: Local renin-angiotensin systems exist within the genitourinary tract, specifically in the bladder and urethra. Experimental data suggest that angiotensin receptor blockade with either angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) decreases both detrusor overactivity and urethral sphincter tone leading to decreased urge incontinence (UUI) and increased stress urinary incontinence (SUI). This has not been examined in a human population. METHODS: Data from the National Health and Nutrition Examination Survey (NHANES) was accessed for the years 2001-2008. Multivariate logistic regression was used for modeling. RESULTS: We studied 8,754 females and 8,886 males who met inclusion criteria. Use of ACE inhibitors or ARBs was not associated with a change in SUI in either men or women. In men, use of an ACE inhibitor or ARB was associated with a statistically significant 25-30% decrease in UUI (monthly or any urge incontinence). A similar, albeit non-significant trend was also seen for daily and weekly UUI. Other antihypertensive medications (diuretics, beta-blockers, calcium-channel blockers) were not associated with a decrease in UUI. In subanalysis, duration of ACE inhibitor or ARB use did not alter the strength of the effect on UUI nor did an elevated prostate specific antigen (PSA) level (used as a surrogate for bladder outlet obstruction due to benign prostatic hypertrophy). ACE inhibitor and ARB use did not affect UUI rates in women, though did show a trend for improvement in nulliparous women without SUI. CONCLUSION: Angiotensin receptor blockade may be a viable treatment approach for the treatment of UUI, especially in men.

Sacral nerve stimulator revision due to somatic growth.

PURPOSE: Sacral nerve modulation is a Food and Drug Administration approved treatment for refractory urgency, frequency, urge incontinence and nonobstructive urinary retention in adults. The sparse literature on sacral nerve modulation in children focuses on its initial efficacy in patients with neurogenic bladder and dysfunctional elimination. We describe our initial experience with sacral nerve modulation and the phenomenon of growth spurts associated with lead malfunction that necessitates revision. MATERIALS AND METHODS: After receiving institutional review board approval we retrospectively reviewed the charts of pediatric patients who underwent sacral nerve modulation surgery at our institution. Charts were examined for patient demographics, subjective success, the need for further surgery and success after revision. RESULTS: Four patients underwent sacral nerve modulation at an average age of 12.1 years. All patients reported initial success, defined as greater than 50% symptom improvement. Subsequently 3 patients required a total of 5 revisions due to lead malfunction with an average of 1.5 years between surgeries. In those requiring revision the average somatic growth between revisions was 8.1 cm. Return of efficacy was reported after each revision. All patients had functioning nerve stimulators in place and continued to have a positive subjective response. CONCLUSIONS: The sparse data on sacral nerve modulation in children shows efficacy and safety similar to those in adults. Somatic growth may be associated with lead malfunction and require surgical revision. We report a small series showing that revision can be done successfully and safely. Informed consent for sacral nerve modulation in pediatric patients should include a discussion of somatic growth as a possible cause of lead malfunction necessitating revision.

Chronic sacral nerve stimulation prevents detrusor structural and functional changes associated with bladder outlet obstruction--a rat model.

AIMS: Bladder outlet obstruction (BOO) can mediate structural and functional detrusor changes, which can lead to bothersome lower urinary tract symptoms. We investigate if sacral nerve stimulation (SNS) can prevent these structural and functional changes in a rat model of BOO. METHODS: 24 female Sprague-Dawley rats (250 gm) were divided into 4 groups: control (CTRL), BOO, SNS, and both (BOO/SNS). BOO was achieved by partially occluding the proximal urethra. SNS involved stimulating the S1-S4 dorsal roots with a unipolar S1 lead, 8 hours daily. Urodynamics were performed at baseline and after 6 weeks. Bladders were harvested, stained, and scored for detrusor hypertrophy and fibrosis (scale = 1-5). RESULTS: BOO caused an increase in mean voiding pressure (P(det) = 35 +/- 2 mmHg vs. 23 +/- 1 mmHg, p = 0.02), an increase in mean bladder capacity (C = 1230 +/- 250 microl vs. 484 +/- 60 microl, p = 0.03), and a decrease in mean volume at first non-voiding contraction (67 +/- 16 microl vs. 110 +/- 24 microl, p = 0.02) compared to CTRL. Addition of SNS neither significantly affected P(det) (30 +/- 3 mm Hg vs. 35 +/- 2 mmHg, p = 0.2), nor C (630 +/- 90 microl vs. 1230 +/- 250 microl, p = 0.06) compared to BOO, but eliminated non-voiding contractions. Detrusor hypertrophy and fibrosis were both significantly greater in BOO vs. CTRL and vs. BOO/SNS. CONCLUSIONS: Partial BOO caused functional and structural changes in the rat bladder. SNS in obstructed rats prevents these alterations, without adversely affecting detrusor contractility.

Sacral nerve stimulation to treat nonobstructive urinary retention in women.

Nonobstructive urinary retention is an uncommon finding in women that may represent a difficult management problem for urologists and patients. Pharmacotherapy and urethral dilatation are rarely successful, and clean intermittent catheterization may be cumbersome. Those patients who cannot self-catheterize may be subjected to an indwelling catheter. Sacral nerve stimulation is a minimally invasive treatment for nonobstructive urinary retention, with 10 years of data documenting its long-term safety and efficacy. This minimally invasive treatment can restore satisfactory voiding in most patients and should be a routine part of treatment for this rare but important condition.

Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men is principally defined by pain in the pelvic region lasting more than 3 months. No cause of the disease has been established, and therapies are empirical and mostly untested. Antimicrobial agents and alpha-adrenergic receptor blockers are frequently used. OBJECTIVE: To determine whether 6-week therapy with ciprofloxacin or tamsulosin is more effective than placebo at improving symptoms in men with refractory, long-standing CP/CPPS. DESIGN: Randomized, double-blind trial with a 2 x 2 factorial design comparing 6 weeks of therapy with ciprofloxacin, tamsulosin, both drugs, or placebo. SETTING: Urology outpatient clinics at 10 tertiary care medical centers in North America. PATIENTS: Patients were identified from referral-based practices of urologists. One hundred ninety-six men with a National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 15 and a mean of 6.2 years of symptoms were enrolled. Patients had received substantial previous treatment. MEASUREMENTS: The authors evaluated NIH-CPSI total score and subscores, patient-reported global response assessment, a generic measure of quality of life, and adverse events. INTERVENTIONS: Ciprofloxacin, 500 mg twice daily; tamsulosin, 0.4 mg once daily; a combination of the 2 drugs; or placebo. RESULTS: The NIH-CPSI total score decreased modestly in all treatment groups. No statistically significant difference in the primary outcome was seen for ciprofloxacin versus no ciprofloxacin (P = 0.15) or tamsulosin versus no tamsulosin (P > 0.2). Treatments also did not differ significantly for any of the secondary outcomes. LIMITATIONS: Treatment lasting longer than 6 weeks was not tested. Patients who had received less pretreatment may have responded differently. CONCLUSION: Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.

Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study.

PURPOSE: The efficacy of sacral neuromodulation for the treatment of symptoms in patients with refractory interstitial cystitis was evaluated. MATERIALS AND METHODS: A total of 25 patients with a mean age of 47 years and refractory interstitial cystitis were prospectively evaluated with a trial of sacral nerve stimulation. Patients who demonstrated 50% improvement in frequency, nocturia, voided volume and average pain qualified for permanent sacral nerve stimulator implantation. Treatment success was measured by voiding diary, report of average pain, and response to the Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index. RESULTS: Of the 25 patients 17 qualified for permanent sacral nerve stimulator implantation. At an average of 14 months followup mean daytime frequency and nocturia improved from 17.1 to 8.7 and 4.5 to 1.1, respectively (p <0.01). Mean voided volume increased from 111 to 264 ml. (p <0.01). Report of average pain decreased from 5.8 to 1.6 points on a scale of 0 to 10 (p <0.01). Interstitial Cystitis Symptom and Problem Index scores decreased from 16.5 to 6.8 and 14.5 to 5.4, respectively (p <0.01). Of the 17 patients 16 (94%) with a permanent stimulator demonstrated sustained improvement in all parameters at the last postoperative visit. CONCLUSIONS: Results of this prospective clinical study demonstrate that sacral neuromodulation is a safe and effective treatment for the dysfunctional voiding and pelvic pain in patients with interstitial cystitis who are refractory to other forms of treatment.