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

NCT07206446 | Not Yet Recruiting

• 2 other identifiers: UNI-2023-007CIV-25-08-054117
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Overactive Bladder (OAB); Over Active Bladder

Keywords

Over active bladder; urogynaecology; prescription digital therapeutic; pdtx; app; mobile app; decentralized; decentralised

Outcome Measures

Primary Outcomes (1)

• Usability

  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 Outcomes (2)

• Improvement in symptoms

  From enrollment to the end of treatment at 8-10 weeks

• Improvement in quality of life

  From enrollment to the end of treatment at 8-10 weeks

Other Outcomes (1)

• Device related serious adverse events

  From enrollment to the end of treatment at 8-10 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

All participants meeting criteria for inclusion and not exclusion will be given access to the app

Device: RiSolve

Interventions

RiSolve DEVICE

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

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Protocol specifies women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Galway: lead
• Enterprise Ireland: collaborator

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Related Links

• Study webpage featuring downloadable Participant Information Leaflet

MeSH Terms

Conditions

Urinary Bladder, Overactive; Alzheimer Disease

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Clinical Trial Coordinator

CONTACT

0035391494368; risolvecoord@universityofgalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Foundation Professor

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: September 29, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share