Eighteen years of experience in laparoscopic implantation of artificial urinary sphincter in women with intrinsic sphincter deficiency.

INTRODUCTION AND OBJECTIVES: Artificial urinary sphincter (AUS) is a treatment option for women with stress urinary incontinence (SUI) after failure of previous surgery or as a primary procedure in severe intrinsic sphincter deficiency (ISD). The aim of the study was to assess the long-term efficacy and risk factors for surgical revision and definitive explantation of AUS laparoscopic implantation in female patients. METHODS: A retrospective review of all women submitted to AUS implantation between April 2005 and March 2023 was conducted. The AUS was implanted via transperitoneal laparoscopic approach, by two experienced surgeons. The primary endpoint was postoperative continence. Continence was defined as no leakage and no pad usage or leakage and/or pad usage with no impact on social life and failure as leakage and/or pad usage impacting social life. As secondary outcomes, clinical predictive factors for AUS revision and definitive explantation were evaluated. RESULTS: In the last 18 years, females with a mean age of 68±12 years-old were submitted to laparoscopic implantation of AUS. Early overall complication rate was 16%, but only one case was Clavien-Dindo ≥3. After a median follow-up of 67 months, 22.2% of the patients needed a device revision, the majority due to mechanical device dysfunction. AUS definitive explantation was performed in 16%, mainly due to urethral/vaginal erosion (9.9%) and infection (6.2%). Patients with age ≥70 years and follow-up ≥10 years significantly predisposed for device revision. At the time of the last follow-up, 72% of the patients were keeping the urinary continency. CONCLUSIONS: Laparoscopic AUS implantation in females is an effective treatment for SUI due to ISD. Meanwhile, adequate patient selection, multidisciplinary evaluation and careful expectation management are essential to achieving good results, concerning their significant complication rate.

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.

Laparoscopic appendicovesicostomy and ileovesicostomy: A step-by-step technique description in neurogenic patients.

AIMS: This study aims to describe our surgical technique and report our preliminary experience with laparoscopic ileal or appendicovesicostomy in adult patients with neurogenic bladder caused by spinal cord injury. SUBJECTS AND METHODS: From January 2014 to March 2017, seven patients were submitted to an appendicovesicostomy under Mitrofanoff procedure and two patients to an ileovesicostomy under Yang-Monti procedure by laparoscopy. Clinical indications were patients with a history of neurogenic bladder secondary to spinal cord pathology, with proper dexterity and willing to have a more accessible continent derivation. Surgical steps include: (1) identification and mobilization of appendix; (2) ligation of appendix' base; (3) endoloop reinforcement of proximal end; (4) silicon catheter insertion in appendix' lumen; (5) mesoappendix dissection; (6) Retzius space opening; (7) posterior bladder dissection; (8) anterior transcutaneous bladder dome fixation; (9) vertical midline detrusor incision; (10) opening of bladder mucosa; (11) excision and espatulation of appendix tip; (12) appendico vesical anastomosis; and (13) exteriorization of appendix through umbilicus and creation of catheterizable stoma. In the two patients submitted to a Yang-Monti diversion, the ileum reconfiguration and calibration was done extracorporeally. One patient had simultaneous bladder augmentation. RESULTS: The mean follow-up was 21.5 ± 11.9 months. The mean operative time was 161 min (123-220). There was no conversion to laparotomy and no need of postoperative blood transfusion. The mean hospitalization length was 4 days. No early postoperative complication was registered. Late postoperative complications were: one surgical stoma revision, one false-passage (solved by transient catheterization), and one bladder stone (solved by endoscopic approach). All patients are continent. CONCLUSIONS: This series presents our laparoscopic technique for continent urinary diversions, showing that it is feasible and safe in adult patients with neurogenic bladder.

[Primary adenocarcinoma of the bladder and renal transplantation]. / Adénocarcinome primitif de vessie et transplantation rénale.

Primary bladder adenocarcinoma is a rare tumour which represents between 0.5% and 2% of malignant bladder tumours. The incidence of malignant tumours is increased in renal transplant recipients. The combination of primary bladder adenocarcinoma and renal transplantation is exceptional. The authors report a case of primary bladder adenocarcinoma in a 34-year-old patient who had undergone renal transplantation 5 years previously. In the light of this case, the authors discuss the various cases reported in the literature and the specific management of this rare tumour.

[Paraneoplastic urticarial vasculitis and renal carcinoma]. / Vasculite urticarienne paranéoplasique et carcinome rénal.

Paraneoplastic syndromes have been described in various types of tumours, but are rarely associated with renal cancer. Paraneoplastic cutaneous manifestations, consisting of urticarial vasculitis are exceptional and can sometimes constitute the presenting sign of a completely asymptomatic renal cancer. This vasculitis resolves after curative treatment of the tumour, confirming its paraneoplastic nature. The authors report a case of a paraneoplastic urticarial vasculitis associated with the discovery of an asymptomatic renal carcinoma in a 37-year-old man and discuss paraneoplastic cutaneous syndromes that must be recognised to allow earlier diagnosis of renal tumours.

[Ureteral multiplicity: report of 3 cases]. / Multiplicité urétérale: à propos de 3 cas.

The ureteric multiplicity is a rare malformation with about one hundred cases described in the literature. The rarity of this anomaly and the complexity of possible associated anomalies often make the preoperative diagnosis difficult. The authors report 1 case of partial quadruplicate ureter associated with bladder duplication and 2 cases of triplicate ureter, corresponding to types I, II and III of Smith's classification. Based on their experience and a review of the literature, they discuss the diagnostic approach and treatment of these anomalies.

[Pelvic pain caused by bladder leiomyoma: diagnostic and radiologic difficulties]. / Algies pelviennes d'un léiomyome de vessie: difficultés diagnostique et radiologique.

Uterine leiomyoma is a frequent benign lesion. It is usually asymptomatic and can be responsible for acquired dysmenorrhoea in some women, leading to gynaecological assessment. However, the development of this type of muscle lesions arising from the bladder wall and accompanied exclusively by dysmenorrhoea is rare. It is very difficult to study the anatomical relations of the lesion and distinguish it from other pelvic, genital or urinary tract tumours. The authors discuss the diagnostic aspects and therapeutic management in the light of a case of bladder leiomyoma in a 39-year-old woman.