Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Turning ON the neuromodulator, Turning OFF the neuromodulator.
- Who it may be relevant to
- Registry conditions: Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis, Sacral Neuromodulation, Bowel Dysfunction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sacral Neuromodulation for Patients With Multiple Sclerosis With Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction. A Multicenter Double-blind, Placebo-controlled Randomized Clinical Trial.
Overview
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.
Interventions
- Device Turning ON the neuromodulator
IPG on - Device Turning OFF the neuromodulator
IPG OFF
Primary outcome measures
- Success of SNM for neurogenic lower urinary tract dysfunction [Time frame: Six months]
- Male bladder function [Time frame: Six months]
- Female bladder function [Time frame: Six months]
Secondary outcome measures (6)
- Changes in bladder volume [Time frame: Six months]
- Changes in bladder sensation Mangler [Time frame: Six months]
- Bowel function [Time frame: Eight months]
- Male sexual function [Time frame: Six months]
- Female sexual function [Time frame: Six months]
- Quality of life by standard questionnaire EQ-5D-5L [Time frame: Six months]
Eligibility criteria
Inclusion criteria
- Refractory neurogenic lower urinary tract dysfunction (nLUTD) defined by visual analogue scale on treatment satisfaction ranging from 0 to 100 (100 means maximal satisfaction with the current treatment). All patients indicating satisfaction less than 50 are considered non-responders/having refractory overactive bladder (OAB) to current treatment
- No effect of medical treatment defined by antimuscarinics, beta3-agonist and alpha-blocker.
- Patients having refractory nLUTD who intend to try SNM for relief of their symptoms
- Expanded Disability Status Scale (EDSS) < 5 and no progression of neurological disease within 6 months
- Written informed consent
- Able to understand the information given about the project
Exclusion criteria
- EDSS > 5, neurological disease with severe progression within the last 6 months and/or unable to manage the electronic devices
- Age < 18 years
- Any other urological pathology but nLUTD
- Bladder Pain Syndrome/Interstitial cystitis
- Any other intestinal or gynecological pathology but neurological conditional symptoms
- Current pelvic malignancy or clinically significant pelvic mass
- Previous pelvis radiotherapy
- Bladder injections with botulinum neurotoxin type A within 6 months before inclusion in trial
- Unable to manage the electronic devices
- Inability to give an informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Odense University Hospital — Odense
Publications
- Kobbero H, Krhut J, Zvara P, Pedersen TB, Fode M, Nielsen HH, Poulsen MH. Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction in Patients With Multiple Sclerosis: A Pilot Trial. Neurourol Urodyn. 2025 Jun;44(5):1109-1119. doi: 10.1002/nau.70052. Epub 2025 Apr 14. PMID 40223778
Identifiers
NCT: NCT05380856 · OdenseOUH