Uterine Prolapse
Conditions
Keywords
Uterine Prolapse, Laparoscopy, Hysterectomy, vaginal
Brief summary
Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.
Interventions
PROCEDURELaparoscopic supracervical hysterectomy with sacropexy
Will involve laparoscopic entry to the abdomen to remove the uterus and suspension of the cervix and vaginal cuff to the sacrum with mesh. We will allow surgeons to conduct the surgery as they have perfected it
PROCEDUREVaginal hysterectomy with uterosacral colposuspension
Will involve removing the uterus vaginally followed by suspending the vaginal cuff to the high (proximal) uterosacral ligaments bilaterally restoring the vagina to its normal axis.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients with primary symptomatic uterine prolapse * ≥ 18 years of age * Considering pelvic reconstructive surgery
Exclusion criteria
* Unwillingness to be randomized to one of two surgical approaches * Pregnant or planning to maintain their future fertility * Unable to have general anesthesia * Currently undergoing chemotherapy OR has current or history of pelvic radiation * Previous adverse reaction to synthetic mesh * Recent history of abnormal paps (past 10 years) * Cervical or uterine cancers * Previous hysterectomy * Previous central vault or uterine prolapse repair * Uterus ≥ 14 weeks size * Uterine cancer * History of significant pelvic adhesive disease * Elongated cervix (length D to C \> 6cm) * Fibroid ≥ 7cm * Post menopausal with enlarged uterus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL) | 24 months | — |
| Absence of re-treatment for prolapse at 2 years | 24 months | — |
| A negative response to Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? | 24 months | This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in POPQ measurements | baseline, 6 week, and 3, 12, and 24 months | — |
| Frequencies of surgical and post-operative complications | up to 2 years post-operatively | Complications will be classified and reported, based on severity. |
| Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment | baseline, 3, 12, and 24 months | EQ-5D assesses a patient's health that day PFDI- pelvic floor discomfort questions PFIQ - pelvic floor impact on daily activity questions SF-12 - general health/quality of life questions Standard Gamble Interview - an overall general health/quality of life questionnaire |
| Change in patient reported sexual questionnaire, PISQ | baseline, 3, 12 and 24 months | PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire |
Countries
United States
Outcome results
None listed