Sexual Function DisturbancesPRIDENCT05072158
Pelvic Floor Disorders Among Sexual Minoritized Women
An observational study of Sexual Function Disturbances and Pelvic Organ Prolapse, run by University of New Mexico at 1 site in United States.
Trial summary
The investigators aim to perform cognitive interviews to assess how pelvic floor disorders impact sexual functioning in women who have sex with women (WSW). As a secondary objective there will be cognitive interviews to assess perceptions of sexual function questionnaires such as Female Sexual Function Index (FSFI)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Function Disturbances, Pelvic Organ Prolapse, Urinary Incontinence
- What is being tested?
- None, this is an observational study
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2021to 29 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: New patients over the age of 18 who present to urogynecology office or contact the research team with interest in participating in the study who self-identify as women who have sex with women. This may include but is not limited to: lesbian and bisexual women.
Who may be able to join
- WSW who have a PFD (pelvic organ prolapse, urinary incontinence, fecal incontinence)
- Age >18
- Able to provide consent
- Able to read/write in English
Who cannot join
- WSW who have not been sexually active in the past 6 months
- Incarcerated patients
- Pregnant or lactating patients
- Unable to consent with study procedures or guided discussions
- Unable to speak English
- No sexual activity in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87106
About this study
The investigators aim to perform cognitive interviews to assess how pelvic floor disorders impact sexual functioning in women who have sex with women (WSW). As a secondary objective there will be cognitive interviews to assess perceptions of sexual function questionnaires such as Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA Revised (PISQ-IR) in WSW.
Read the detailed description
There is a paucity of data regarding care of women who have sex with women (WSW). While some cohort studies are being performed in general gynecology, no studies document the reasons as to why WSW seek urogynecological care, or how pelvic floor disorders (PFDs) affect sexual function in this population. Another detrimental gap in current knowledge and a barrier to care for WSW is the lack of understanding of what would drive WSW to seek care, if there are special considerations for care, or if the commonly used condition specific questionnaires adequately reflect their concerns. The Investigators aim to perform qualitative interviews to understand how PFDs affect sexual function, and if commonly utilized sexual function questionnaires are inclusive to WSW.
- Conditions
- Sexual Function Disturbances, Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence
- Being tested
- None, this is an observational study
- Medical subject headings
- Sexual Dysfunctions, Psychological, Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, this is an observational studyOther
This is a qualitative study, we will be asking for patient experiences with PFDs and the impact on their sexual function.
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative impact of pelvic floor disorders on sexual function
We will assess the impact of pelvic floor disorders with qualitative analysis and informational interviews
Measured: 6 months
Secondary outcomes (1)
Qualitative inclusivity of sexual function questionnaires
We will examine this with guided focus groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start14 Oct 2021
- Primary completion29 Jun 2022
- Study completion29 Jun 2022
Why it stopped: PI has confirmed this is not a clinical trial and was entered in error in the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Function DisturbancesStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Albany Medical College, University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Sierra Jansen, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072158
- Sponsor's protocol ID
- 21-196
- Acronym
- PRIDE
- Status last verified
- Jan 2024
- First submitted
- 18 Aug 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Disorders Among Sexual Minoritized Women
- ClinicalTrials.gov ID
- NCT05072158
- Acronym / sponsor ID
- PRIDE / 21-196
- Conditions
- Sexual Function Disturbances, Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI has confirmed this is not a clinical trial and was entered in error in the system.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Albany Medical College, University of Texas at Austin
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 8 Oct 2021 (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 investigators aim to perform cognitive interviews to assess how pelvic floor disorders impact sexual functioning in women who have sex with women (WSW). As a secondary objective there will be cognitive interviews to assess perceptions of sexual function questionnaires such as Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA Revised (PISQ-IR) in WSW.
Detailed description
There is a paucity of data regarding care of women who have sex with women (WSW). While some cohort studies are being performed in general gynecology, no studies document the reasons as to why WSW seek urogynecological care, or how pelvic floor disorders (PFDs) affect sexual function in this population. Another detrimental gap in current knowledge and a barrier to care for WSW is the lack of understanding of what would drive WSW to seek care, if there are special considerations for care, or if the commonly used condition specific questionnaires adequately reflect their concerns. The Investigators aim to perform qualitative interviews to understand how PFDs affect sexual function, and if commonly utilized sexual function questionnaires are inclusive to WSW.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New patients over the age of 18 who present to urogynecology office or contact the research team with interest in participating in the study who self-identify as women who have sex with women. This may include but is not limited to: lesbian and bisexual women.
Key inclusion criteria (4 listed)
- WSW who have a PFD (pelvic organ prolapse, urinary incontinence, fecal incontinence)
- Age >18
- Able to provide consent
- Able to read/write in English
Key exclusion criteria (6 listed)
- WSW who have not been sexually active in the past 6 months
- Incarcerated patients
- Pregnant or lactating patients
- Unable to consent with study procedures or guided discussions
- Unable to speak English
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 |
|---|---|---|
| None, this is an observational studyThis is a qualitative study, we will be asking for patient experiences with PFDs and the impact on their sexual function. | Other | – |
Primary outcome
Qualitative impact of pelvic floor disorders on sexual function
Time frame: 6 months
We will assess the impact of pelvic floor disorders with qualitative analysis and informational interviews
1 secondary outcome
Qualitative inclusivity of sexual function questionnaires
Time frame: 6 months
Results and safety
The study was stopped early (reason given: PI has confirmed this is not a clinical trial and was entered in error in the system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Sierra Jansen, MD principal investigator
University of New Mexico
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 Sexual Function Disturbances and Pelvic Organ Prolapse, run by University of New Mexico 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Jan 2024. 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 was stopped early (reason given: PI has confirmed this is not a clinical trial and was entered in error in the system.). Results are not available in the source record.
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?
Qualitative impact of pelvic floor disorders on sexual function (time frame: 6 months). 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 12 Jan 2024.