Five-year Results from the Prospective, Multicenter, Observational SOUNDS Study of Patients with Overactive Bladder Treated with the InterStim System for Sacral Neuromodulation.

BACKGROUND: Although sacral neuromodulation (SNM) for overactive bladder (OAB) is an established therapy, there is a lack of high-quality, long-term data on real-life practice. OBJECTIVE: To report on real-life therapeutic effectiveness, quality of life (QoL), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up. DESIGN, SETTING, AND PARTICIPANTS: A total of 291 OAB patients were enrolled at 25 French sites according to local standard of care. Sacral neuromOdUlation with InterStim therapy for intractable lower uriNary tract DySfunctions (SOUNDS) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Over the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annually thereafter. Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo. RESULTS AND LIMITATIONS: The mean number of daily leaks in urinary urge incontinence (UI) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p < 0.001). Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p < 0.05). Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement UI patients, and 68% (39/57) and 67% (10/15) of UI patients were categorized as therapy responders by showing a >50% improvement in leaks. Disease severity (Urinary Symptom Profile domain 2), Numeric Rating Scale-based symptom bother, and disease-specific QoL (Ditrovie) improved significantly in both groups at all visits (p < 0.001). Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (Clavien-Dindo grade I and II). Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients. CONCLUSIONS: SOUNDS demonstrates the sustained effectiveness and QoL improvements of SNM in OAB patients after 5 yr in real-world conditions while maintaining an acceptable safety profile consistent with literature. PATIENT SUMMARY: This study confirmed that French overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation.

Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study.

BACKGROUND: SOUNDS strengthens the evidence basis of sacral neuromodulation (SNM) for overactive bladder (OAB) through real-world data. OBJECTIVE: To analyze diary-based effectiveness, quality of life (QoL), disease severity, symptom bother, and safety data for SNM with the InterStim system up to 3 yr after implantation. DESIGN, SETTING, AND PARTICIPANTS: Twenty-five representative French sites enrolled 291 patients with OAB followed according to the local standard of care. Overall, 229 patients received a de novo or replacement InterStim implant and had four follow-up visits, two within the first yr and annually thereafter. A total of 190 patients completed the fourth follow-up visit after a mean of 33.7 ± 3.7 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The effectiveness outcomes measured were changes in daily voids and leaks and the therapy responder rates. Other outcomes included validated QoL data (Ditrovie and EuroQol 5-dimension 5-level questionnaires), disease severity (Urinary Symptom Profile [USP]), symptom bother rated using a numeric rating scale (NRS), and safety data. Follow-up data were compared to baseline results using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Average daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p < 0.05) except for voids at 21 mo in the group receiving a replacement device. The therapeutic response for urinary urge incontinence at the fourth follow-up was 72% for the de novo group and 86% for the replacement group. Disease-specific QoL (Ditrovie), OAB-specific symptom severity (USP domain 2), and NRS-rated disease bother were significantly improved at all visits (p < 0.001). Device- or procedure-related adverse events occurred in 49% of patients, with 68% of the events classified as minor (Clavien-Dindo grade I or II). Surgical revisions were performed in 33% of patients, including permanent removal in 13%, over a mean exposure time of 44.4 ± 15.3 mo. CONCLUSIONS: This study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life. PATIENT SUMMARY: Our study in French patients with overactive bladder showed that disease symptoms and bother were significantly reduced and quality of life was significantly improved over a study duration of approximately 3 yr after implantation of a device to stimulate nerves that control the bladder. This trial is registered at ClinicalTrials.gov as NCT02186041.

Sacral Neuromodulation with the InterStim™ System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study.

BACKGROUND: Real-world data that support the use of sacral neuromodulation (SNM) for lower urinary tract dysfunctions are of continued interest. OBJECTIVE: To evaluate the effectiveness, quality of life (QoL), patient-reported outcomes (PROs), and safety of SNM with the InterStim™ system in real life during 1-yr postimplant. DESIGN, SETTING, AND PARTICIPANTS: This is a prospective, multicenter, observational study at 25 representative public and private French sites. Eligible patients received SNM therapy for overactive bladder (OAB) and non-obstructive urinary retention based on local standard of care. Overall, 320 patients were enrolled; 247 received permanent implant or replacement; 204 implanted patients completed second follow-up after mean of 10.0±3.8 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Effectiveness outcomes were change in voids, leaks, and catheterizations/day. Other outcomes included validated QoL and disease severity scores as well as PROs and adverse event data. Outcomes at follow-ups were compared with baseline using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Voids in urinary frequency (UF) and leaks/day in urinary urge incontinence (UI) patients were significantly reduced after 10 mo in both de novo (mean baseline voids/day UF de novo: 12.7 vs 8.6 after 10 mo; p<0.001; mean baseline leaks/day UI de novo: 4.3 vs 1.1 after 10 mo; p<0.001) and replacement patients (mean baseline voids/day UF replacement: 11.5 vs 7.9 after 10 mo; p<0.001; mean baseline leaks/day UI replacement: 5.4 vs 1.0 after 10 mo; p<0.001). Disease bother, Urinary Symptom Profile score, and Ditrovie questionnaire score were also significantly improved. Revisions postimplant occurred in 20% of patients including in 9% due to permanent explantation during a mean exposure time of 24.3 mo. CONCLUSIONS: Through a real-life study, SOUNDS (Sacral neuromOdUlation with InterStim™ therapy for intractable lower uriNary tract DySfunctions) confirms the clinical effectiveness, safety, and positive effect of SNM on QoL and PROs for the treatment of OAB patients. PATIENT SUMMARY: These analyses on French patients who received sacral neuromodulation (SNM) for retention or OAB during a 10-mo period showed that SNM improved OAB symptoms, quality of life, and reduced disease bother. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02186041.

Do Failure of Posterior Tibial Nerve Stimulation Precludes to Use Sacral Neuromodulation in Patient With Overactive Bladder?

PURPOSE: To evaluate the outcomes of sacral neuromodulation (SNM) after failure of transcutaneous posterior tibial nerve stimulation (TPTNS) in patients with overactive bladder (OAB). METHODS: A retrospective study was conducted in 3 university hospitals and included all patients with OAB and treated with SNM after TPTNS had been tried between October 2008 and May 2018. The primary endpoint was the proportion of definitive SNM device implantation in patients with 50% objective and/or subjective improvement after a test period (stage 1). The secondary outcomes of interest were changes of the number of diurnal voids and nocturia episodes per 24 hours between the end of TPTNS and the end of stage 1. RESULTS: Overall, 28 of the 43 patients included achieved at least 50% objective and/or subjective improvement during stage 1 and underwent an Interstim II implantation (65.1%). The mean daytime frequency decreased significantly from 10.3/day at the end of TPTNS to 7.8 diurnal voids/day at the end of SNM stage 1 (P=0.01). The mean number of nocturia episodes decreased from 2.5/night at the end of TPTNS to 2.1/night at the end of stage 1, but this did not reach statistical significance (P=0.18). There was no other parameter significantly associated with response to SNM. CONCLUSION: SNM might improve OAB symptoms in most patients who experienced no or poor efficacy with TPTNS. History of failed TPTNS should not preclude the use of SNM in OAB patients.

Transcutaneous tibial nerve stimulation: 2 years follow-up outcomes in the management of anticholinergic refractory overactive bladder.

PURPOSE: To evaluate long-term use, efficacy and tolerability of transcutaneous tibial nerve stimulation (TTNS) in the treatment of refractory overactive bladder (OAB). METHODS: We performed a prospective observational study and included all patients treated in a single center for OAB persisting after first-line anticholinergic treatment, with ≥ 24 months follow-up. The protocol consisted of daily stimulation at home. The primary outcome was treatment persistence. Amelioration was defined as an improvement in urinary symptom profile (USP) score. RESULTS: We assessed 84 consecutive patients. After a mean follow-up of 39.3 months and a mean treatment use of 8.3 months, almost two-thirds of patients (71.8%) had discontinued TTNS. Treatment continuation was > 12 months for 28 patients (33.3%) and > 18 months for 16 patients (19%). TTNS was successful following 3 months of treatment in 60 (71%) patients. Mean USP score stayed significantly lower than baseline until 12 months of treatment, but was not significant anymore after 18 months. Discontinuation therapy reasons were a lack of sufficient symptom relief for 59 (70%) patients, compliance difficulty for 5 (6%) patients and becoming asymptomatic for 6 (8%) patients. No serious adverse events occurred. CONCLUSIONS: The present study confirms the utility of TTNS as a treatment option for patients with resistant OAB. In the long-term use, few patients continued with therapy, mostly because of a decreased effectiveness with time.

Geriatric Assessment Can Predict Outcomes of Endoscopic Surgery for Benign Prostatic Hyperplasia in Elderly Patients.

Ojectives: Surgical management of benign prostatic hyperplasia (BPH) in elderly patients is associated with higher morbidity and mortality rate. This raises the question of benefice and risk balance. We conducted a prospective observational study to evaluate the results of endoscopic surgery for BPH in elderly patients, according to geriatric assessment. PATIENTS AND METHODS: We included prospectively 60 patients older than 75 years, with an indwelling catheter for acute or chronic retention, who were candidates to endoscopic surgery for BPH. Patients underwent the brief geriatric assessment (BGA) and the comprehensive geriatric assessment (CGA) to classify them into three groups: "vigorous," "vulnerable," and "sick." Success was defined by the bladder catheter withdrawal after surgery. RESULTS: After geriatric assessment, 33 patients were classified in the "vigorous" group (55%), 25 in the "vulnerable" group (42%), and 2 in the "sick" group (3%). The success rate immediately after surgery was 85% and 41% in the "vigorous patient" group and the "vulnerable and sick" patient group, respectively (p < 0.05). The success rate at 3 months after surgery was 94% and 55% (p < 0.05). The morbidity was higher for the "vulnerable and sick" group (44%) compared with the "vigorous" group (15%) (p < 0.05). The BGA also allowed predicting a higher risk of failure in patients with a score ≥3 immediately after surgery (odds ratio 5.9, confidence interval [95% CI] 1.61, 29.9) and 3 months after surgery (odds ratio 6.9, 95% CI 1.31, 70.8). CONCLUSION: Geriatric assessment can predict the outcome of endoscopic surgery for BPH for patients in retention older than 75 years. "Vulnerable and sick" patients had a higher risk to keep their indwelling catheter after the surgery compared with "vigorous" patients. The complication rate is also higher. The BGA can although predict a poor result of surgery when its score is equal or above 3/6.

Transcutaneous posterior tibial nerve stimulation: evaluation of a therapeutic option in the management of anticholinergic refractory overactive bladder.

INTRODUCTION AND HYPOTHESIS: This study evaluated the efficacy and tolerability of transcutaneous posterior tibial nerve stimulation (TPTNS) in the treatment of overactive bladder (OAB) after failure of a first-line anticholinergic treatment. MATERIALS AND METHODS: We performed a prospective observational study and included all patients treated in a single center for OAB persisting after first-line anticholinergic treatment from November 2010 to May 2013. The protocol consisted of daily stimulation at home. The efficacy end point was defined as improvement on the Urinary Symptom Profile (USP) and the French-validated urinary symptom score Mesure du Handicap Urinaire (MHU). RESULTS: We assessed 43 consecutive patients. TPTNS was successful following 1 month of treatment in 23 (53%) patients. Bladder capacity was the only predictive factor for treatment success (p = 0.044). For patients who showed improved symptoms (n = 23; 53%), mean MHU and USP decreased significantly, from 11.8 ± 2.8 to 5.6 ± 3 (p < 0.001) and from 14 ± 3.3 to 6.9 ± 3.2 (p < 0.001), respectively. After a mean follow-up of 10.8 ± 1.6 months, 21 (49%) patients continued the TPTNS. Mean MHU and USP scores were 4.4 ± 2.8 and 5.4 ± 3.5, respectively, and stayed lower than baseline (p < 0.001). Patients reported no adverse events. CONCLUSION: TPTNS is well tolerated and is effective in one half of the patients studied after they failed anticholinergic treatment. TPTNS could become a second therapeutic option before surgical treatment in the management strategy of OAB.

Double-J ureteral stent under local anesthesia for women.

INTRODUCTION: Ureteral stent placement is a key urologic procedure used to manage ureteral obstructions. It is usually performed under general anesthesia (GA) with its inherent risks. The objective was to evaluate safety, feasibility and tolerance of ureteral stent placement under local anesthesia (LA) in women. MATERIALS AND METHODS: From January 2010 to January 2013, we prospectively and consecutively reviewed all female patients who had an urgent retrograde ureteral stent placement under LA. Only primary stent placements were included in the study. Pain was assessed after surgery by Visual Analog Scale (VAS) and pain and comfort assessment during stent placement were reported. We compared outcomes and tolerance with patients under general anesthesia (GA) matched by age and operatives indications during the same period. RESULTS: We included 36 patients (18 under LA and 18 under GA) with a mean age of 59.4 +/- 22.4 years. The mean operative time was 24.4 +/- 12.9 min and 18.8 +/- 6.5 min in LA group and GA group (p = 0.110), respectively. One patient needed GA due to a poor tolerance. The mean perioperative VAS scores under LA and GA were 5.89 +/-2.95 and 2.06 +/- 2.67 (p < 0.0001), respectively. There were no intraoperative complications in either group. The procedure was painful for 16 (88.8%) patients from the LA group and 9 (50%) patients would not accept to undergo this intervention under LA again. CONCLUSION: Ureteral stent placement under LA in women can be performed safely and effectively. However, this procedure is painful and should be proposed only to selected cases.

Detailed analysis of morbidity following nephrectomy for renal cell carcinoma in octogenarians.

PURPOSE: We evaluated the morbidity of nephrectomy in patients older than age 80 years. MATERIALS AND METHODS: Between June 2002 and March 2011, 2,530 patients underwent surgery for renal tumor at 5 French academic centers. Of these patients 180 (7.1%) were age 80 years or older, including 22 (12%) and 158 (88%) who underwent partial and radical nephrectomy, respectively, and 47 (26.1%) who were treated with a laparoscopic approach. RESULTS: Mean patient age was 82.3 years. Median Charlson score was 4. Mean preoperative glomerular filtration rate was 47 ml/minute. A total of 136 complications were recorded in 70 patients (38.8% of all patients). Of the patients 28 (15.5%), 25 (13.9%) and 17 (9.4%) experienced 1, 2 and 3 or more complications, respectively. According to the modified Clavien classification grade I, II, III, IV and V complications were observed in 7, 81, 19, 23 and 6 patients, respectively. The transfusion rate was 31.1% (56). On logistic regression analysis the parameters of Eastern Cooperative Oncology Group Performance Status 2 to 4 (p = 0.035) and preoperative glomerular filtration rate less than 30 ml/minute (p = 0.03) were independent predictive factors of morbidity. CONCLUSIONS: Morbidity and mortality are significant in the octogenarian population. The risk of complications should be considered in decision making for patients with renal cell carcinoma older than age 80 years.

Overall mortality after radical nephrectomy in patients aged over 80 years with renal cancer: a retrospective study on preoperative prognostic factors.

OBJECTIVES: To evaluate the overall survival postnephrectomy for renal cancer for patients aged over 80 years, and to identify preoperative prognostic factors that might influence therapeutic strategies. METHODS: In a retrospective study in five French departments of urology, 179 patients aged over 80 years with renal cell carcinoma underwent radical nephrectomy between 1990 and 2011. The following data were collected: age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiology class, Eastern Cooperative Oncology Group Performance Status, type of surgery, period of follow-up, survival, death etiology, symptoms, Fuhrman grade and tumor-nodes-metastasis stage. RESULTS: After a 29.6-month follow up, 89 patients (49.7%) died. Death etiologies were: cancer for 46 (52%) patients, immediate or distant perioperative complications for five patients (6%) and three patients (3%) respectively, cardiovascular disease for 16 patients (18%), other cancers for three patients (3%) and unknown for 16 patients (18%). In a multivariate analysis, T-stage, M-stage and Charlson Comorbidity Index were identified as independent prognostic factors. Patients were divided into three groups (good, intermediate and bad prognosis) with significantly different survivals of 91, 36 and 22 months (P < 0.0001), respectively. CONCLUSIONS: Preoperative data, including T-stage, M-stage and Charlson Comorbidity Index represent significant independent prognostic factors for survival for patients aged over 80 years. These data might help the clinician in selecting the most suitable candidates for radical nephrectomy among elderly patients with renal cancer.