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RECRUITING
NCT05380856
NA

Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

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

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-09-26

Completion Date

2027-03-01

Last Updated

2025-03-20

Healthy Volunteers

No

Interventions

DEVICE

Turning ON the neuromodulator

IPG on

DEVICE

Turning OFF the neuromodulator

IPG OFF

Locations (1)

Odense University Hospital

Odense, Fyn, Denmark