Status:
NOT_YET_RECRUITING
A Prospective Evaluation of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women: The RiSolve Trial
Lead Sponsor:
University of Galway
Collaborating Sponsors:
Enterprise Ireland
Conditions:
Overactive Bladder (OAB)
Over Active Bladder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The RiSolve Trial is a prospective, single-arm, post-market clinical investigation designed to evaluate the effectiveness, usability, and safety of a prescription digital therapeutic (PDTx) for women ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07206446
Start Date
September 29 2025
End Date
December 31 2025
Last Update
October 3 2025
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