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

NCT05395793 | Completed

• 1 other identifier: 18-009815
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Measure feasibility and acceptability of focus group

  Baseline, 2 weeks, 4 weeks

Interventions

Support Group OTHER

Support Group with moderator

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females with urinary incontinence
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women with incontinence who are able to attend all three focus groups

You may qualify if:

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

You may not qualify if:

• Those unable to attend all three focus group sessions

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Urination Disorders; 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

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Aqsa Khan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor Department of Urology

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 27, 2022
• Study Start: April 1, 2019
• Primary Completion: September 29, 2019
• Study Completion: September 29, 2019
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)