Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and S

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.

RecruitingNot a drug-phase studyMS (type not specified)NCT05380856

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Turning ON the neuromodulator

Placebo

  • Turning OFF the neuromodulator

What it measured

Main measures

  • Success of SNM for neurogenic lower urinary tract dysfunction

    Six months

    Bladder, bowel and sexual function

  • Male bladder function

    Six months

    Bladder, bowel and sexual function

  • Female bladder function

    Six months

    Bladder, bowel and sexual function

Other measures (6)

  • Changes in bladder volume

    Six months

    Bladder, bowel and sexual function

  • Changes in bladder sensation Mangler

    Six months

    Bladder, bowel and sexual function

  • Bowel function

    Eight months

    Bladder, bowel and sexual function

  • Male sexual function

    Six months

    Bladder, bowel and sexual function

  • Female sexual function

    Six months

    Bladder, bowel and sexual function

  • Quality of life by standard questionnaire EQ-5D-5L

    Six months

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 80

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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

Papers

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History

    1. Started

      Aug 2023

    2. Main results due

      Sept 2027

    3. Finished

      Sept 2027

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