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New treatment option for Neurogenic Dysfunction of the Urinary Bladder
Official title Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
ClinicalTrials.gov ID: NCT05380856
What this study is testing
- What it's testing
- A multi-center double-blinded placebo-controlled randomized clinical trial. The patients will be randomized into two groups.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Refractory neurogenic lower urinary tract dysfunction (nLUTD) defined by visual analogue scale on treatment satisfaction ranging from 0 to 100 (100...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Fyn, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Fyn, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.