NCT07206446 · NOT YET RECRUITING

A Prospective Evaluation of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women: The RiSolve Trial

This trial is testing a smartphone app called RiSolve that delivers an eight-week behavioral therapy program for women with overactive bladder. It is a Phase NA, single-arm study — meaning all participants use the app and there is no comparison group. Researchers are measuring how usable the app is, and whether symptoms and quality of life improve. It is a post-market study of an already CE-marked device, not a first-in-human test.

Eligibility criteria

Inclusion Criteria:
* Adult women aged 18 and older with bothersome OAB symptoms: (i.e. must answer YES to one of the following):
  * Do you have a sudden need to rush to the toilet to urinate that is bothersome? OR
  * Does urine leak before you can get to the toilet?
* Fluency and literacy in English to enable them to understand and complete treatment and required assessments
* Currently based in the Republic of Ireland
* Ownership and use of a smartphone
* Use of at least one mobile App
* Willing to forego commencing any other OAB treatments outside of RiSolve for the trial treatment period.
Exclusion Criteria:
* Current use of an anticholinergic/beta-agonist, within the previous two weeks and/or at the date of consenting
  * Currently using intermittent or indwelling catheter
  * Currently pregnant or planning pregnancy during the study treatment period
  * Currently receiving treatment for bladder/urethral, colon/anal, or cervical cancer
  * Voiding dysfunction (i.e. if Yes is an answer to any of the following):
    * Do you have pain in your bladder? OR
    * Do you have to strain to urinate?
  * Currently using sacral or tibial neuromodulation.
  * Has had intradetrusor therapy
  * Currently taking antibiotics/drugs for urinary tract infection
  * Planning surgery for pelvic organ prolapse within the trial treatment period
  * Planning to undergo pessary fitting during the study period (Note: patients with an existing pessary are eligible) within the trial treatment period
  * Visual impairment such that in the opinion of the PI would impair their use of the app

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-10-03

View full record on ClinicalTrials.gov

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