Pelvic Organ Prolapse
Conditions
Brief summary
This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus. An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.
Interventions
PROCEDURELevel III support procedure
A level III support procedure is aimed at repairing the distal support of the vagina with either a posterior colporrhaphy and/or a perineorrhaphy.
PROCEDUREMinimally Invasive Sacrocolpopexy
All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.
OTHERTransperineal ultrasound of the Pelvic Floor
Subjects from either arm will be invited to participate in this exploratory arm of the study. If they choose to participate, they will have a preoperative ultrasound performed and an ultrasound performed at the time of their 6 month visit.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Postoperative pelvic exams measuring anatomic recurrence of pelvic organ prolapse will be performed by a qualified examiner masked to the original surgery randomization.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female subjects with pelvic organ prolapse (POP) * Planning a surgical repair of POP with minimally invasive sacrocolpopexy * Preoperative resting genital hiatus measure between 4.0 and 7.5cm
Exclusion criteria
subjects who are unable to complete questionnaires or repeat office exams or if they do not otherwise meet inclusion criteria above \*Note: we will NOT exclude patients based on prior surgical history (including prior posterior colporrhaphy)\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enlarged Genital Hiatus at 6 months postoperatively | 6 months postoperatively | Proportion of subjects with enlarged genital hiatus on pelvic exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective prolapse recurrence | 24 months | Any symptomatic recurrence of prolapse on questionnaire |
| Dyspareunia postoperatively | 6, 12 months postoperatively | Incidence of pain with sex (dyspareunia), ascertained with the use of a validated questionnaire for sexual function \[the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)\].This questionnaire indicates worse pain with sex with higher score. |
| Composite prolapse recurrence | 12 months | Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary. |
| Pelvic Floor Distress Inventory Change | baseline, 6, 12 months postoperatively | Measurement of pelvic floor distress change, using the Pelvic Floor Distress Inventory questionnaire (PFDI-20) which is a validated questionnaire used for pelvic floor disorders and their impact on patient quality of life. |
| Levator Hiatal Area | baseline, 6 months postoperatively | Measurement of the levator hiatus on transperineal ultrasound |
| Sexual Function postoperatively | 6, 12 months postoperatively | Assessment of sexual function, ascertained with the use of a validated questionnaire for sexual function \[the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)\]. This questionnaire helps us determine what impact pelvic organ prolapse has on sexual activity. |
Countries
United States
Outcome results
None listed