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

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

Conditions

• Neurogenic Dysfunction of the Urinary Bladder
• Multiple Sclerosis
• Sacral Neuromodulation
• Bowel Dysfunction
• Sexual Dysfunction
• Quality of Life

Interventions

DEVICE

Turning ON the neuromodulator

IPG on

DEVICE

Turning OFF the neuromodulator

IPG OFF

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Université de Nantes

  collaborator OTHER

• University of Ostrava

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Hanne Kobberø · Odense University Hospital

• Mads H Poulsen · Odense University Hospital

• Morten Blaabjerg · Odense University Hospital

• Helle H Nielsen · Odense University Hospital

• Mikkel Fode · Herlev/Gentofte

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-26

Primary Completion

2027-03-01

Completion

2027-03-01

FDA Device

Yes

Countries

• Denmark

Study Locations