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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neurogenic Dysfunction of the Urinary Bladder
- Sponsor
- Odense University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Male bladder function
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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
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.
Investigators
Hanne Kobberø
Principal investigator, MD
Odense University Hospital
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
Outcomes
Primary Outcomes
Male bladder function
Time Frame: Six months
Male lower urinary tract symptoms (MLUTS) by standard International Consultation on Incontinence Questionnaire (ICIQ)-MLUTS 10/06. Scale ranges from 0 to 44 points. Higher score indicate greater impact of individual symptoms for the patient. Changes will be compared to basal data.
Female bladder function
Time Frame: Six months
Female lower urinary tract symptoms (FLUTS) by standard questionnaire ICIQ-FLUTS 12/07. Scale ranges from 0 to 48 points. Higher score indicate greater impact of individual symptoms for the patient. Changes will be compared to basal data.
Success of SNM for neurogenic lower urinary tract dysfunction
Time Frame: Six months
Success is defined 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 volumen, compared to the baseline values using BLADDER DIARY for three days before inclusion and at evaluation.
Secondary Outcomes
- Bowel function(Eight months)
- Changes in bladder volume(Six months)
- Male sexual function(Six months)
- Female sexual function(Six months)
- Changes in bladder sensation Mangler(Six months)
- Quality of life by standard questionnaire EQ-5D-5L(Six months)