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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05380856
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Odense University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hanne KobberøMads H PoulsenMorten BlaabjergHelle H NielsenMikkel Fode
Principal Investigator Affiliation Odense University HospitalOdense University HospitalOdense University HospitalOdense University HospitalHerlev/Gentofte
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis, Sacral Neuromodulation, Bowel Dysfunction, Sexual Dysfunction, Quality of Life
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: IPG turned ON

Continous neuromodulation

Placebo Comparator: IPG turned OFF

No neuromodulation

Interventions

Device: - Turning ON the neuromodulator

IPG on

Device: - Turning OFF the neuromodulator

IPG OFF

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Odense University Hospital, Odense, Fyn, Denmark

Status

Recruiting

Address

Odense University Hospital

Odense, Fyn, 5000

Site Contact

Hanne Kobberø

[email protected]

+4565414400

Nearest Location

Site Contact

Hanne Kobberø

[email protected]

+4565414400


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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