Urinary IncontinenceNCT05395793
In-person Focus Groups in the Management of Urinary Incontinence in Women
An observational study of Urinary Incontinence, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Support Group
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 29 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult women with incontinence who are able to attend all three focus groups
Who may be able to join
- 18 years or older
- English-speaking
- Have the ability to commute to the meeting facility without institutional assistance
Who cannot join
- Those unable to attend all three focus group sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of In-person Focus Groups in the Management of Urinary Incontinence in Women From a Mixed-methods, Randomized Pilot Study
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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Support Group
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support GroupOther
Support Group with moderator
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks
Change in physical activity
Measured using the International Physical Activity Questionnaire (IPAQ) to assess physical activity as part of everyday life.
Measured: Baseline, 12 weeks
Secondary outcomes (1)
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
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Apr 2019
- Primary completion29 Sep 2019
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqsa A. Khan, Mayo Clinic
- Investigators
- Aqsa Khan, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395793
- Sponsor's protocol ID
- 18-009815
- Status last verified
- May 2023
- First submitted
- 12 Apr 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of In-person Focus Groups in the Management of Urinary Incontinence in Women From a Mixed-methods, Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05395793
- Acronym / sponsor ID
- 18-009815
- Conditions
- Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 29 Sep 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with incontinence who are able to attend all three focus groups
Key inclusion criteria (3 listed)
- 18 years or older
- English-speaking
- Have the ability to commute to the meeting facility without institutional assistance
Key exclusion criteria (1 listed)
- Those unable to attend all three focus group sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support GroupSupport Group with moderator | Other | – |
Primary outcome
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.
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).
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.
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.
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)
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.
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.
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.
1 secondary outcome
Measure feasibility and acceptability of focus group
Time frame: Baseline, 2 weeks, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aqsa Khan, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mixed urinary incontinence symptoms (time frame: Baseline, 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.