Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT05380856
Brief Summary:
A multi-center double-blinded placebo-controlled randomized clinical trial.
The patients will be randomized into two groups.
To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD).
After first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF.
Period of randomization: four months. Number anticipated to be included: 60 patients
Detailed Description:
Patients with MS often suffer from pelvic-organ dysfunctions, i.e. lower urinary tract (LUT), bowel and sexual dysfunction, aside their cerebral affection. Sacral neuromodulation (SNM) is a reversible minimal invasive procedure affecting the function of the aforementioned pelvic organs. Changes in bladder, bowel and sexual function will be monitored.
Primary outcome:
Success of SNM for lower urinary tract dysfunction as improvement of at least 50% in the key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to the baseline values.
Secondary outcome:
To assess the changes in bladder, bowel and sexual function due to SNM by using subjective patient reported outcome measures, quality of life and global assessment score,
* To assess the changes in urodynamic variables,
* To assess the safety of SNM for NLUTD and
* To register the implantation characteristics and the need for reprogramming
Data will be collected at Baseline 1: At inclusion Baseline 2: At evaluation after a three weeks test period Baseline 3: At randomization Baseline 4: At the end of study
The time frame of the RCT is six months
Patients with improvements of bowel symptoms only will be excluded from the trial but followed with the same questionnaires for the same time.
The patients will be followed-up every 6 months for a total of 5 years.
Study:
NCT05380856
Study Brief:
Protocol Section:
NCT05380856