Sexual FunctionFaVRNCT01779739
Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy
A study testing Perineorrhaphy in people with Sexual Function, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
This is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. Read more about this study
- Who is it for?
- Ages 19 to 105 years, women only
- Conditions the study is for
- Sexual Function
- What is being tested?
- Perineorrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Feb 2017
- Phase
- Interventional
- 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 19 to 105 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sexually active
- genital hiatus measured between 4 and 6 centimeters
- desires sexual function
- undergoing vaginal repair with native tissues
- agrees to use vaginal estrogen for 12 months after surgery
Who cannot join
- genital hiatus > 6 cm
- planned obliterative procedure
- perineal body length <0.5cm
- disrupted external anal sphincter
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
This is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. We hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.
- Conditions
- Sexual Function
- Being tested
- Perineorrhaphy
- Keywords
- vaginal prolapse, sexual function, sexual dysfunction, prolapse surgery
- Medical subject headings
- Uterine Prolapse, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerineorrhaphyProcedure or surgery
Procedure to build up the vaginal opening
| Study group | Role | What they receive |
|---|---|---|
| No perineorrhaphy | No intervention | Subjects will not have a perineorrhaphy procedure added to the vaginal prolapse repair |
| Perineorrhaphy | Active comparator | Subjects will have a perineorrhaphy added to the vaginal repair of prolapse Receives: Procedure: Perineorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sexual function as measured by validated questionnaire
Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery.
Measured: 6 months and 12 months after surgery
Secondary outcomes (1)
Prolapse recurrence
A composite outcome score to define success of prolapse surgery will be applied to subjects at 6 and 12 months specifically looking for return of prolapse symptoms, anatomic recurrence, and need for retreatment
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual FunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candace Y Parker-Autry, MD, Study director, Wake ForestHolly E Richter, PhD, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779739
- Sponsor's protocol ID
- IRB00037135
- Acronym
- FaVR
- Status last verified
- Feb 2018
- First submitted
- 28 Jan 2013
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy
- ClinicalTrials.gov ID
- NCT01779739
- Acronym / sponsor ID
- FaVR / IRB00037135
- Conditions
- Sexual Function
- Keywords
- vaginal prolapse, sexual function, sexual dysfunction, prolapse surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 30 Jan 2013 (estimated)
- 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.
This is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. We hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No perineorrhaphy | No intervention | –Subjects will not have a perineorrhaphy procedure added to the vaginal prolapse repair |
| Perineorrhaphy | Active comparator | Procedure: PerineorrhaphySubjects will have a perineorrhaphy added to the vaginal repair of prolapse |
Who may qualify
- Ages
- 19 to 105 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- sexually active
- genital hiatus measured between 4 and 6 centimeters
- desires sexual function
- undergoing vaginal repair with native tissues
- agrees to use vaginal estrogen for 12 months after surgery
Key exclusion criteria (4 listed)
- genital hiatus > 6 cm
- planned obliterative procedure
- perineal body length <0.5cm
- disrupted external anal sphincter
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 |
|---|---|---|
| PerineorrhaphyProcedure to build up the vaginal opening | Procedure or surgery | Perineorrhaphy |
Primary outcome
Change in sexual function as measured by validated questionnaire
Time frame: 6 months and 12 months after surgery
Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery.
1 secondary outcome
Prolapse recurrence
Time frame: 6 months, 12 months
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 22 Feb 2018.
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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.
Candace Y Parker-Autry, MD study director
Wake Forest
Holly E Richter, PhD, MD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineorrhaphy in people with Sexual Function, run by Wake Forest University Health Sciences at 2 sites 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 5 inclusion and 4 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 sexual function as measured by validated questionnaire (time frame: 6 months and 12 months after surgery). 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 22 Feb 2018.