In-person Focus Groups in the Management of Urinary Incontinence in Women

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT05395793
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to investigate how a support group with other individuals who share the condition urinary incontinence (UI) impacts patients experience with management of urinary incontinence.

Detailed Description

Focus groups in various settings have demonstrated the ability to alleviate psychological and physiological distress in focus group participants. The exploration of focus groups is warranted to measure the potential benefit for patients with urinary incontinence. Researchers aimed to assess the feasibility and acceptability of in-person focus groups as a potential intervention for female patients with urinary incontinence from a mixed methods approach. A mixed methods pilot study will be conducted to investigate whether in-person focus group demonstrate meaningful significance in quantitative outcomes measured by validated questionnaires and qualitative outcomes analyzed from focus group transcripts and post-session surveys. This study was an initial assessment to determine whether in-person focus groups for females with UI is strong enough to warrant further research and clinical implementation.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-09-29
• Study Completion: 2019-09-29
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• 18 years or older
• English-speaking
• Have the ability to commute to the meeting facility without institutional assistance

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Exclusion Criteria

• Those unable to attend all three focus group sessions

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in urinary tract condition severity	Baseline, 12 weeks	Measured using the Patient Global Impression of Severity (PGI-S) questionnaire which consists of one question that asks subject to describe urinary tract condition currently on a scale of 1=normal, 2=mild, 3=moderate, 4=severe.
Change in physical activity	Baseline, 12 weeks	Measured using the International Physical Activity Questionnaire (IPAQ) to assess physical activity as part of everyday life.
Change in sexual quality of life	Baseline, 12 weeks	Measured using the Sexual Quality of Life Questionnaire- Female (SQoL-F) which consists of 18 questions to assess the relationship of sexual dysfunction and quality of life on a scale of 1-6 (1=completely agree; 6=completely disagree. Higher total scores indicate greater quality of life.
Change in urinary tract condition improvement	Baseline, 12 weeks	Measured using the Patient Global Impression of Improvement (PGI-I) questionnaire which consists of one question that asks subject to rate urinary tract condition currently, compared with how it was before taking medication on a scale of 1-7 (1=very much better; 7=very much worse)
Change in Patient Health Questionnaire	Baseline, 12 weeks	Measured using the Patient Health Questionnaire (PHQ-9) which consists of 9 questions to assess depressive symptoms using a scale of 0-3 (0=not at all; 3=nearly every day). Higher total scores indicate greater severity depression.
Change in mixed urinary incontinence symptoms	Baseline, 12 weeks	Measured using the Medical, Epidemiological, and Social Aspects of Aging (MESA) incontinence questionnaire which consists 15 questions to measure urgency of urinary incontinence and stress urinary incontinence on a 0-3 scale (0=Never, 3=Often). Higher total scores indicating higher severity of urge and stress incontinence.
Change in urinary distress	Baseline, 12 weeks	Measured using the Urogential Distress Inventory-6 (UDI-6) questionnaire which consists of 6 questions that rate urinary distress experience and how much it subjects are bothered by them on a 0-3 scale (0=not at all; 3=greatly).
Change in overactive bladder satisfaction with treatment	Baseline, 12 weeks	Measured using the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q) which consists of 11 questions rating satisfaction or dissatisfaction with treatment for overactive bladder.

Secondary Outcome Measures

Name	Time	Method
Measure feasibility and acceptability of focus group	Baseline, 2 weeks, 4 weeks	written survey was administered at the beginning of each focus group session which incorporated open-ended warm-up questions regarding urinary incontinence and concluded with the assessment of the level of focus group comfort on a scale from 1-5

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States