Fecal Incontinence Clinical Trial
Official title:
Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: The Development of a Symptom Assessment Tool in Sacral Neuromodulation: A Prospective Single Centre Study.
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.
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. ;
| 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| Withdrawn |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 |
NCT01957969 -
French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
|
N/A | |
| Completed |
NCT01939821 -
A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes
|
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 | |
| Completed |
NCT00565136 -
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT00522691 -
Efficacy of Sacral Nerve Stimulation Before Definitive Implantation
|
N/A | |
| 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: Eclipse™ 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 |