Neurogenic Lower Urinary Tract Dysfunction: Study on Neuromodulation in Humans
A study aims to examine the effects of turning on a neuromodulator versus turning it off in patients with neurogenic lower urinary tract dysfunction (nLUTD). It includes 60 patients, focusing on whether the intervention leads to a 50% improvement in bladder diary variables over a follow-up period of 5 years. The study is still recruiting, and no results are available yet.
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- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
Understanding the efficacy of neuromodulation for nLUTD could provide new treatment options for managing this condition, which severely affects patient quality of life.
What this does not prove
No results have been posted, and the study is still recruiting participants. The primary endpoints and outcomes have not yet been established.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- 60 · basis not reported
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- All
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (10)
subjectsThe patients will be randomized into two groups.
sample sizeNumber anticipated to be included: 60 patients
peer reviewedNo results are posted.
relevant ms types"eligibilityCriteria": "Inclusion Criteria:\n\n* 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).
intervention"Device: Turning OFF the neuromodulator"
comparator"Device: Turning OFF the neuromodulator"
primary endpoint"description": "Success is defined as improvement of at least 50% in the key bladder diary variables, i.e.
follow upnumber of voids and/or number of leakages, post void residual) compared to the baseline values.\n\nSecondary outcome:\n\nTo 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,\n\n* To assess the changes in urodynamic variables,\n* To assess the safety of SNM for NLUTD and\n* To register the implantation characteristics and the need for reprogramming\n\nData 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\n\nThe time frame of the RCT is six months\n\nPatients with improvements of bowel symptoms only will be excluded from the trial but followed with the same questionnaires for the same time.\n\nThe patients will be followed-up every 6 months for a total of 5 years."
findingsChanges in bladder, bowel and sexual function will be monitored.\n\nPrimary outcome:\n\nSuccess of SNM for lower urinary tract dysfunction as improvement of at least 50% in the key bladder diary variables (i.e.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
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