Randomized controlled trial in adult women with urinary incontinence comparing treatment delivered through a mobile application versus standard care.

Recruiting

• Conditions: rinary incontinence, Stress-incontinence, Urge-incontinence

• Registration Number: NL-OMON25754
• Lead Sponsor: Department of General practiceUniversity Medical Centre GroningenUniversity of Groningen

Brief Summary

oohuis AMM, Wessels NJ, Jellema P, Vermeulen KM, Slieker-Ten Hove MC, van Gemert-Pijnen JEWC, Berger MY, Dekker JH, Blanker MH. The impact of a mobile application-based treatment for urinary incontinence in adult women: Design of a mixed-methods randomized controlled trial in a primary care setting. Neurourol Urodyn. 2018 Sep;37(7):2167-2176. doi: 10.1002/nau.23507. PMID: 29392749 https://doi.org/10.1002/nau.23507 Van der Worp H, Loohuis AMM, Flohil I, Kollen BJ, Wessels NJ, Blanker MH. Recruitment through media and general practitioners resulted in comparable samples in an RCT on incontinence. Journal of Clinical Epidemiology (online first: https://doi.org/10.1016/j.jclinepi.2019.12.001)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

Subject must meet all of the following criteria:

- Women, 18 years or older;

Exclusion Criteria

Potential participant who meets any of the following criteria will be excluded from study:

- Indwelling urinary catheter;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in symptoms score, measured with the International consultation on Incontinence Questionnaire on UI Short Form (ICIQ-UI-SF), 4 months after randomization

Secondary Outcome Measures

Name	Time	Method
All secondary endpoints are assessed 4 and 12 months after<br>randomization.<br /><br>- Patient-reported Global Impression of Improvement;<br /><br>- Condition-specific quality of life;<br /><br>- Generic health related quality of life;<br /><br>- Number of incontinence episodes per day<br /><br>- Sexual functioning<br /><br>- frequency, severity and impact of incontinence (every month during first 4 months)<br /><br>- Costs at 12 months<br /><br>- Process evaluation: Evaluation of user friendliness and acceptability of patients and health-care workers.