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

Официальное название

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.

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Turning ON the neuromodulator
  IPG on
• Устройство Turning OFF the neuromodulator
  IPG OFF

Первичные конечные точки

• Success of SNM for neurogenic lower urinary tract dysfunction [Срок оценки: Six months]
• Male bladder function [Срок оценки: Six months]
• Female bladder function [Срок оценки: Six months]

Вторичные конечные точки (6)

• Changes in bladder volume [Срок оценки: Six months]
• Changes in bladder sensation Mangler [Срок оценки: Six months]
• Bowel function [Срок оценки: Eight months]
• Male sexual function [Срок оценки: Six months]
• Female sexual function [Срок оценки: Six months]
• Quality of life by standard questionnaire EQ-5D-5L [Срок оценки: Six months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Odense University Hospital — Odense

Публикации

• 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

Идентификаторы

NCT: NCT05380856 · OdenseOUH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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