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SOUNDS strengthens the evidence basis of sacral neuromodulation (SNM) for overactive bladder (OAB) through real-world data.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.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.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.Average daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p0.05) 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 (p0.001). 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.This study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life.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.

International audience; BackgroundReal-world data that support the use of sacral neuromodulation (SNM) for lower urinary tract dysfunctions are of continued interest.ObjectiveTo 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 participantsThis 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 analysisEffectiveness 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 limitationsVoids 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.ConclusionsThrough 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 summaryThese 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 registrationClinicalTrials.gov: NCT02186041

We evaluate the efficacy of the AMS 800 artificial urinary sphincter in women with type III incontinence.We enrolled 207 women with genuine stress incontinence due to intrinsic sphincter deficiency. Primary inclusion criterion was a negative Marshall test. A modified surgical procedure was used to implant the AMS 800 through an abdominal approach, with placement of the cuff around the bladder neck between the periurethral fascia and vagina. Followup data were available for 206 women, including 179 with nonneurogenic and 27 with neurogenic bladders (mean followup 3.9 years).There were 12 (5.9%) explantations due to the prosthesis either through an erosion, extrusion or both that were necessary. The only significant risk factor for explantation was perioperative injury. This injury resulted in 8 explantations in 49 patients compared with 4 in 155 who did not have such injuries (p = 0.0016). Of the 190 patients with working devices continence was achieved in 88.7% (49 of 168) and 81.8% (18 of 22) of those with nonneurogenic and neurogenic bladders, respectively. Social continence (slight leakage but no pad use) was reported by 7.7% (13 of 168) and 9.1% (2 of 22) of patients in the nonneurogenic and neurogenic groups, respectively. The remaining patients reported leakage and pad use.The AMS 800 can be used successfully to treat women with genuine stress incontinence due to intrinsic sphincter deficiency. The modified surgical approach resulted in fewer perioperative injuries and, consequently, a low explantation rate. Women with genuine stress incontinence, a low urethral closure pressure and negative Marshall test indicating severe intrinsic sphincter deficiency are potential candidates for artificial urinary sphincter implantation.

Background . Andrew's thoracopleuroplasty has been described for treating tuberculous empyemas with bronchopleural fistulas. We report on its utilization for treating postpneumonectomy empyemas. Methods . During a 25 year period, 23 patients underwent thoracopleuroplasty for treating postpneumonectomy empyemas, after a period of drainage-irrigation of the cavity. Seven patients presented with persistent bronchial fistula at operation. After resection of the costal arches surrounding the infected cavity, the cavity was cleaned, and the external parietal plane was sutured to the mediastinal plane. Only drainage of the subscapular space was left in place. Results . Postoperative mortality was 4.3%. Postoperative recovery was simple in 17 cases, whereas a superficial abscess was evacuated in 3 cases. The procedure failed in 3 cases, which were treated by open thoracostomy (2), and by reenlargment of the thoracopleuroplasty (1). The sequelae were mainly a diminution of the shoulder mobility, especially when the first rib was resected. Conclusions . Thoracopleuroplasty may safely treat postpneumonectomy empyemas, even those with bronchial fistulas. Most patients are definitively and rapidly cured with limited sequelae.