Sexual Function
Conditions
Keywords
vaginal prolapse, sexual function, sexual dysfunction, prolapse surgery
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.
Interventions
PROCEDUREPerineorrhaphy
Procedure to build up the vaginal opening
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 105 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* genital hiatus \> 6 cm * planned obliterative procedure * perineal body length \<0.5cm * disrupted external anal sphincter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sexual function as measured by validated questionnaire | 6 months and 12 months after surgery | Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolapse recurrence | 6 months, 12 months | 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 |
Countries
United States
Outcome results
None listed