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

June 10, 2026 updated by: Andrew Murphy, University of Galway

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 suffering from overactive bladder (OAB). The study is sponsored by the University of Galway and led by Professor Andrew W. Murphy. It is scheduled to begin in August 2025 and conclude in March 2026, and will be conducted through the Primary Care Clinical Trials Network at the University of Galway. Sixty adult women based in the Republic of Ireland will be recruited to take part. Eligible participants must be at least eighteen years old, fluent in English, own a smartphone, and report bothersome OAB or urgency incontinence symptoms. Women who are pregnant, receiving certain bladder-related treatments, or using specific medications or devices will be excluded.

Overactive bladder is a chronic condition defined by urgency, urinary frequency, nocturia, and often urgency incontinence. It is highly prevalent among women and significantly impacts quality of life, with effects ranging from sleep disruption to reduced occupational performance and heightened risks of anxiety and depression. Standard treatment guidelines recommend a tiered approach, beginning with behavioural therapy, followed by pharmacological options, and finally invasive procedures such as Botox injections or neuromodulation. Behavioural therapy, although considered the gold standard, is often difficult for patients to access due to limited provider availability, cost, and stigma. RiSolve was developed to overcome these barriers by offering a comprehensive, digital, prescription-only therapeutic program.

The investigational device, the RiSolve App (REF: PDTxA001), is a CE-marked Class I medical device developed in accordance with the EU Medical Device Regulation (MDR 2017/745). It delivers an eight-week structured program combining behavioural therapy with a novel digital cognitive behavioural therapy component. Content includes bladder training, pelvic floor exercises, urge suppression strategies, education on bladder health and diet, and general wellbeing modules covering sleep, stress, and exercise. The app also provides interactive tools such as quizzes, bladder diaries, and personalised feedback. Patients complete clinically validated questionnaires and receive auto-generated progress reports, which are also shared with healthcare providers. In its design, RiSolve builds on earlier pilot work with a prior app developed at the University of Galway, which demonstrated improvements in OAB symptoms and quality of life.

The primary aim of the study is to assess usability of the RiSolve App, measured using the user version of the Mobile Application Rating Scale (uMARS). Secondary objectives include evaluating symptom improvement using the Overactive Bladder Questionnaire short-form Symptom Severity scale (OAB-q SF SS) and assessing quality of life changes with the OAB-q SF HQoL scale. Safety outcomes will focus on identifying any device-related serious adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Galway, Ireland
        • Primary Care Clinical Trial Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
All participants meeting criteria for inclusion and not exclusion will be given access to the app
Device: RiSolve

RiSolve is a Class I device in accordance with Rule 11 of Annex VIII of EU Medical Device Regulation (MDR) 2017/745. The RiSolve App is a smartphone application that users can download following a diagnosis of OAB by a healthcare provider, and following prescription of the RiSolve App. RiSolve consists of an 8-week program including activities to set baselines and assess progress, treatment modules, and modules to enhance engagement.

As part of setting baselines and assessing progress, participants complete a series of clinically validated questionnaires. This data is presented to users to promote self-monitoring of behaviours and a deeper understanding of their symptoms. A patient report is auto-generated at the end of treatment. This is sent to the patient and contains their in-app self-generated data, their questionnaire results and their bladder diary data (see Appendix 1: RiSolve Patient Report). This information is also provided to the prescribing healthcare provider as an object

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability
Time Frame: From enrollment to the end of treatment at 8-10 weeks
Usability as measured by the User version of the Mobile Application Rating Scale (uMARS)
From enrollment to the end of treatment at 8-10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in symptoms
Time Frame: From enrollment to the end of treatment at 8-10 weeks
Improvement in symptoms, as measured on the Overactive Bladder Questionnaire-Short Form, Symptom Severity (OABq-SF SS) scale
From enrollment to the end of treatment at 8-10 weeks
Improvement in quality of life
Time Frame: From enrollment to the end of treatment at 8-10 weeks
Improvement in quality of life, as measured by the Overactive Bladder Questionnaire-Short Form, health-related quality of life scale (OABq-SF HQoL)
From enrollment to the end of treatment at 8-10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device related serious adverse events
Time Frame: From enrollment to the end of treatment at 8-10 weeks
Number of device related serious adverse events
From enrollment to the end of treatment at 8-10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Galway

Collaborators

Enterprise Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Actual)

February 17, 2026

Study Completion (Actual)

February 17, 2026

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

September 26, 2025

First Posted (Actual)

October 3, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNI-2023-007
  • CIV-25-08-054117 (Other Identifier: Health Products Regulatory Authority (EUDAMED ID))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Proprietary data, sharing would give up competitive advantage

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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