Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT05380856
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05380856
Study Brief:
Protocol Section:
NCT05380856