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Completed

NCT Number: NCT05395793

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Support Group

Other

Support Group with moderator

Primary outcomes

  1. Change in mixed urinary incontinence symptoms

    Time frame: 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.

  2. Change in urinary distress

    Time frame: 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).

  3. Change in overactive bladder satisfaction with treatment

    Time frame: 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.

  4. Change in urinary tract condition severity

    Time frame: 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.

  5. Change in urinary tract condition improvement

    Time frame: 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)

  6. Change in sexual quality of life

    Time frame: 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.

  7. Change in Patient Health Questionnaire

    Time frame: 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.

  8. Change in physical activity

    Time frame: Baseline, 12 weeks

    Measured using the International Physical Activity Questionnaire (IPAQ) to assess physical activity as part of everyday life.

Secondary outcomes

  1. Measure feasibility and acceptability of focus group

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 27, 2022
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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