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.

[Preliminary results of botulinum toxin in the treatment of benign prostatic hyperplasia]. / Premiers résultats de la toxine botulique dans le traitement de l'hyperplasie bénigne de la prostate.

Botulinum toxin was first used in urology in the field of neuro-urology as treatment for detrusor-sphincter dyssynergia and incontinence due to neurogenic overactive bladder. Its action has now been clearly demonstrated and it is now widely used for the treatment of neurogenic overactive bladder. Can botulinum toxin also constitute an effective treatment for benign prostatic hyperplasia (BPH)? Intraprostatic botulinum toxin injections have been shown to have a significant clinical and urodynamic efficacy by acting on both the static and dynamic components of BPH. The advantages of botulinum toxin are its ease of use, the absence of any reported adverse effects and its prolonged duration of action. Well conducted, prospective, controlled studies on larger sample sizes must now be performed to confirm these preliminary results. This review of the literature presents the preliminary results of intraprostatic botulinum toxin injection supporting its use in the treatment of symptomatic benign prostatic hyperplasia.

[Prospective study of the treatment of localised ureteric strictures by wire mesh stent]. / Etude prospective de traitement des sténoses urétérales localisées par endoprothèse grillagée métallique.

AIMS: To assess efficacy of Mémotherm BARD ureteral metallic stent in the treatment of non-operable ureteral stenoses. MATERIAL AND METHOD: Prospective evaluation of ureteral stenoses consecutively treated using Mémotherm BARD ureteral metallic stent. Assessment criteria (recurrence frequency, permeability, tolerance, complications) were measured by clinical examination, Intra Veinous Pyelography, renal sonography, urine culture at 1, and every 3 months. RESULTS: Thirteen stents were inserted in 12 patients (mean age: 68 yrs) presenting with subsequent ureteral stenosis (9 neoplastic, 3 following radiotherapy) over a 3 year period. No technical difficulty was observed. Mean follow-up was 19 months. Stenosis recurrence was observed in 5 patients, due to tumoural progression, but with no tumour in-growth. There was non incrustation or migration, pain, hematuria, infection due to the stent. All stent remained permeable and functional in surviving patients. CONCLUSIONS: In our experience, Mémotherm BARD ureteral metallic stent could be considered a useful cost-effective alternative to double J stent or traditional surgery in non-operable or end-of-life patients. The high ureteral stenosis recurrence rate was linked to the patient initial pathology. Considering these encouraging results, this study could represent the first stage of a multicenter tracker-study, which would permit to take into account further technological development of this type of material.

[Vesicovaginal fistula after transobturator tape]. / Fistule vésico-vaginale après bandelette transobturatrice.

The transobturator approach is gradually replacing the retropubic approach for the treatment of female stress urinary incontinence and suburethral tape. The major argument in favour of this approach is the decreased risk of bladder injury during insertion of the needles, which nevertheless remains a minor complication. Provided another more median approach is used in closer contact with the bone, followed by prolonged bladder catheterization for 24 to 48 hours, this complication has no consequences. However, the authors report a case of bladder injury during insertion of transobturator tape (TOT) in a patient with no particular history, attributable to the technique itself as it occurred during finger dissection towards the obturator membrane. This complication led to secondary formation of a vesicovaginal fistula after insertion of the tape, despite satisfactory repair of the bladder This case illustrates that TOT is not devoid of risks to the bladder; with sometimes even serious consequences. TOT should not be inserted when bladder suture is required. If a fistula is observed after insertion of TOT the tape should be completely removed as soon as possible, but correction of urinary incontinence may persist.

[Secondary appearance of a carcinoma in an excluded native bladder: Report of three cases]. / Apparition secondaire d'un carcinome sur vessie native exclue: à propos de trois cas.

INTRODUCTION: The management of congenital urological malformations is sometimes complex and may require urinary diversion. Cystectomy is usually performed, but sometimes the bladder is left in place due to the presence of a pelvic cloaca and the morbidity related to this type of surgery. MATERIAL: The authors report three cases of patients treated by urinary diversion for a congenital malformation without primary resection of the bladder RESULTS: In the absence of any infectious complications, bladder carcinoma on an excluded native bladder was diagnosed at the age of 3 years, 4 years and 38 years, respectively. Histological examination showed transitional cell carcinoma in two cases and gastrointestinal-type adenocarcinoma of the bladder in 1 case. CONCLUSION: The risk of secondary development of carcinoma in an excluded bladder during management of (congenital urological malformations is not negligible. Primary cystectomy therefore appears to be preferable. In the presence of a pelvic cloaca making this surgical resection unreasonable, it appears important to exclude the formation of a pyocyst by annual abdominal ultrasound. The authors also recommend cystoscopy and urine cytology with lavage to detect degeneration of the bladder mucosa.

[Fibro-urothelial polyp in a horseshoe kidney in the case of Turner syndrome]. / Polype fibro-urothélial sur rein en fer a cheval dans le cas d'un syndrome de Turner.

The authors report a case of fibro-epithelial polyp in a young woman with Turner syndrome with features of a right ureteropelvic junction syndrome in a horseshoe kidney. The patient presented a history of chronic low back pain associated with macroscopic haematuria leading to various complementary investigations including ureteroscopy. The endoscopic appearance of the tumour suggested the diagnosis despite the presence of atypical renal pelvis cytology. Pyeloplasty and proximal ureterectomy allowed confirmation and treatment of this rare lesion.