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.

[Intraurethral injections of Zuidex: evaluation of the morbidity of the technique in the treatment of female urinary incontinence]. / Injections endo-urétrales de Zuidex: évaluation de la morbidité de la technique dans le traitement de l'incontinence urinaire de la femme.

OBJECTIVE: To evaluate the feasibility and morbidity of intraurethral injections of dextranomer/hyaluronic acid (Zuidex), performed under local anaesthesia as an outpatient procedure in the treatment of female urinary incontinence. MATERIAL AND METHODS: Twenty one patients with a mean age of 67 years (range: 29-93 years) presenting urinary incontinence related to sphincter incompetence were treated by intraurethral injection of Zuidex. Injections were performed with the Implacer system provided with the product under local anaesthesia. RESULTS: For nine of these patients (43%), a second injection after 6 weeks was performed due to an insufficient result on incontinence. A total of 30 injections were therefore performed. No significant problem was observed during the injections. Three injections (10%) were difficult because of a short urethra. In 7 cases (23%), the patient reported pain during the injection. In 3 cases (10%), macroscopic haematuria was observed after treatment and another 4 cases (13%) developed lower urinary tract infection. Six patients (20%) developed transient acute urinary retention with resumption of micturition after 24 to 48 hours. CONCLUSION: Intraurethral injection of Zuidex has the advantage of being minimally invasive and can be performed under local anaesthesia, as an outpatient procedure, with good safety and a low complication rate. Resumption of spontaneous voiding must be monitored in view of the risk of urinary retention. The long-term results have not yet been evaluated.

[Relationship between the Area Under the Curve of detrussor contraction during micturition and the usual parameters of flow-pressure rate in women]. / Relations entre l'Aire Sous la Courbe de la contraction du détrusor pendant la miction et les paramètres usuels de l'examen pression-débit chez la femme.

OBJECTIVES: The aim of this work was to assess the relationship between a new urodynamic parameter Area Under Curve of detrusor pressure during voiding (AUCdet) and the usual pressure flow study parameters. MATERIAL AND METHODS: 103 women with various urinary symptoms (incontinence, dysuria, chronic bladder pain or frequent urinary infection) had a urodynamic evaluation with pressure flow analysis. The intravesical pressure was measured through a 6CH Porges Neoplex and the intra-abdominal pressure through a 6CH rectal catheter in an empty rectum. Pressure-flow study was performed one time in each patient. The maximum flow rate (Qmax), the detrusor pressure at maximal flow (PdetQmax), the vesical pressure at maximal flow (PvesQmax), the urethral resistance defined as the ratio between the PvesQmax and Qmax2 (RU) and the AUCdet/Vol were recovered. RESULTS: 85 women were included and mean age was 55 years old. The averages were 19.42 for Qmax, 28.91 for PdetQmax, 63.85 for PvesQmax, 2.10 for RU and 7.83 for AUCdet/Vol. The correlation with AUCdet/Vol were for Qmax -0.80 p < 0.0001, for PdetQmax 0.71 p < 0.0001, for PvesQmax 0.42 p < 0.001 and for RU 0.84 p < 0.0001. CONCLUSIONS: AUCdet/Vol is the first urodynamic parameter which takes into account the whole detrusor contraction during voiding. AUCdet/Vol is relatively close to the urethral resistance. The very high degree of correlation between RU and AUCdet/Vol confirms clinically this definition of the RU. Further studies are needed to assess the validity of AUCdet/Vol.

Diagnosis of female bladder outlet obstruction and relevance of the parameter area under the curve of detrusor pressure during voiding: preliminary results.

PURPOSE: The diagnosis of bladder outlet obstruction in women by pressure flow study may be difficult because there are several definitions of bladder outlet obstruction, several parameters and no standard cutoffs. We evaluated the ability of pressure flow studies to separate women into unobstructed, equivocal and obstructed groups. MATERIALS AND METHODS: In a prospective study 85 women with lower urinary tract symptoms underwent clinical evaluation, including physical examination, voiding cystourethrography, endoscopy, flow rate and post-void residual volume measurement. A pressure flow study was performed 15 days later. The pressure flow study parameters were maximum flow, post-void residual volume, detrusor pressure at maximum flow, vesical pressure at maximum flow, area under the curve of detrusor pressure during voiding and area under the curve of detrusor pressure during voiding adjusted for voided volume. After considering the clinical evaluation 2 urologists classified the patients into 3 groups, namely unobstructed, equivocal and obstructed, as the traditional classification. Linear discriminant analysis was then performed using the traditional classification and pressure flow study data. RESULTS: Mean patient age was 55 years (range 18 to 83). According to the traditional classification there were 36 unobstructed, 28 equivocal and 21 obstructed cases. Significant differences were noted in all pressure flow study parameters (analysis of variance p <0.05). Linear discriminant analysis showed that area under the curve of detrusor pressure during voiding adjusted for voided volume was the most statistically discriminating parameter. Of the cases 86%, 36% and 57% were identically categorized by the traditional and area under the curve of detrusor pressure during voiding adjusted for voided volume parameter classifications in the unobstructed, equivocal and obstructed groups, respectively. The other pressure flow study parameters showed less satisfactory results. CONCLUSIONS: Area under the curve of detrusor pressure during voiding adjusted for voided volume appears to be the most discriminating urodynamic parameter of female bladder outlet obstruction. Other studies are needed to test the reliability and validity of this new parameter.