NCT05380856 Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
| NCT ID | NCT05380856 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Neurogenic Dysfunction of the Urinary Bladder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-09-26 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-09-26 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Hanne Kobberø
PRINCIPAL INVESTIGATOR
Odense University Hospital
Frequently Asked Questions
Who can join the NCT05380856 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Neurogenic Dysfunction of the Urinary Bladder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05380856 currently recruiting?
Yes, NCT05380856 is actively recruiting participants. Contact the research team at hanne.kobberoe2@rsyd.dk for enrollment information.
Where is the NCT05380856 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT05380856 clinical trial?
NCT05380856 is sponsored by Odense University Hospital. The principal investigator is Hanne Kobberø at Odense University Hospital. The trial plans to enroll 60 participants.