Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy
FaVR
1 other identifier
interventional
44
1 country
2
Brief 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. We hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 28, 2013
CompletedFirst Posted
Study publicly available on registry
January 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFebruary 22, 2018
February 1, 2018
4.6 years
January 28, 2013
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in sexual function as measured by validated questionnaire
Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery.
6 months and 12 months after surgery
Secondary Outcomes (1)
Prolapse recurrence
6 months, 12 months
Study Arms (2)
No perineorrhaphy
NO INTERVENTIONSubjects will not have a perineorrhaphy procedure added to the vaginal prolapse repair
Perineorrhaphy
ACTIVE COMPARATORSubjects will have a perineorrhaphy added to the vaginal repair of prolapse
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- genital hiatus \> 6 cm
- planned obliterative procedure
- perineal body length \<0.5cm
- disrupted external anal sphincter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Candace Y Parker-Autry, MD
Wake Forest
- PRINCIPAL INVESTIGATOR
Holly E Richter, PhD, MD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2013
First Posted
January 30, 2013
Study Start
July 1, 2012
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
February 22, 2018
Record last verified: 2018-02