Clinical Trials Logo

Clinical Trial Summary

Sacral neuromodulation (SNM) is a two-staged 2nd-line therapy for therapy-resistant LUTS and fecal incontinence. Currently, the assessment of symptoms at baseline and after stage I is directed towards a discipline related evaluation. The OptiLUTS trial strives for a more holistic approach, taking all pelvic floor dysfunctions into account. A holistic assessment tool will be developed and SNM-care pathway will be set-up.


Clinical Trial Description

A prospective single centre trial is set up. Patients planned for the two-staged tined lead procedure are enrolled. Bladder and bowel diaries and patient reported outcome measures (PROMS) will be collected at baseline and in between stage I and stage II, and PROMS at one month, 6 months and 12 months after definitive implant. Phase I Step 1: The current implant rate, true success rate, outcomes and false positive rate will be measured. Step 2: Development of a holistic symptom assessment tool. Phase II Implementation of the SNM care pathway. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05313984
Study type Observational
Source University Hospital, Ghent
Contact
Status Completed
Phase
Start date March 1, 2018
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03825575 - Sacral Neuromodulation as Treatment for Fecal Incontinence N/A
Completed NCT00605826 - A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence N/A
Withdrawn NCT02208258 - Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool. N/A
Completed NCT01939821 - A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes N/A
Completed NCT01957969 - French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence N/A
Completed NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry N/A
Recruiting NCT00530933 - Tibial Nerve Stimulation for Faecal Incontinence N/A
Withdrawn NCT00522691 - Efficacy of Sacral Nerve Stimulation Before Definitive Implantation N/A
Completed NCT00565136 - Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms Phase 1/Phase 2
Completed NCT00677508 - Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Completed NCT05032534 - Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence N/A
Completed NCT05058326 - Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
Completed NCT03746834 - NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation Phase 4
Completed NCT00124904 - Biofeedback for Fecal Incontinence N/A
Completed NCT03028636 - LIBERATE - PRO: Eclipseâ„¢ System Registry
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1
Completed NCT05621629 - Management of FI After Surgery of ARM
Withdrawn NCT04138602 - BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence N/A
Completed NCT03252951 - Physical Therapy for Anal Incontinence N/A
Completed NCT04478799 - Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience N/A