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

Urinary Incontinence Clinical Trial

Official title:

The Role of In-person Focus Groups in the Management of Urinary Incontinence in Women From a Mixed-methods, Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395793
• Other study ID #: 18-009815
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: September 29, 2019

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 29, 2019
• Est. primary completion date: September 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• English-speaking

• Have the ability to commute to the meeting facility without institutional assistance

Exclusion Criteria:

• Those unable to attend all three focus group sessions

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• Support Group
Support Group with moderator

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mixed urinary incontinence symptoms	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.	Baseline, 12 weeks
Primary	Change in urinary distress	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).	Baseline, 12 weeks
Primary	Change in overactive bladder satisfaction with treatment	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.	Baseline, 12 weeks
Primary	Change in urinary tract condition severity	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.	Baseline, 12 weeks
Primary	Change in urinary tract condition improvement	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)	Baseline, 12 weeks
Primary	Change in sexual quality of life	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.	Baseline, 12 weeks
Primary	Change in Patient Health Questionnaire	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.	Baseline, 12 weeks
Primary	Change in physical activity	Measured using the International Physical Activity Questionnaire (IPAQ) to assess physical activity as part of everyday life.	Baseline, 12 weeks
Secondary	Measure feasibility and acceptability of focus group	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	Baseline, 2 weeks, 4 weeks

External Links

•   Mayo Clinic Clinical Trials