Clinical trial NCT01802281: Study of Uterine Prolapse Procedures - Randomized Trial
Official title: A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterovaginal Prolapse
Lead sponsor: NICHD Pelvic Floor Disorders Network
Sponsor class: NETWORK
Collaborators: name: Boston Scientific Corporation
First posted: 2013-03-01
Enrollment: 183
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years.

A supplemental study investigates anterior vaginal wall movement resulting from descent or rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the study arms of SUPeR.

Detailed description: The study population will be adult women (\>21 years of age) with symptomatic uterovaginal prolapse at or beyond the hymen who desire vaginal surgical management. This study is intended to be done only on women who have completed child-bearing and have an inactive uterus, defined as amenorrhea for 1 year. Therefore women will be postmenopausal or will have amenorrhea from an endometrial ablation. Amenorrhea caused from exogenous steroids, or hypothalamic disorders will not allow inclusion.

Participants will be obtained from the clinic population of each of the eight Pelvic Floor Disorders Network (PFDN) sites. Participants will be randomly assigned to have either vaginal hysterectomy and USLS or mesh hysteropexy suspension for treatment of their uterovaginal prolapse. The surgical assignment will be revealed in the operating room, after the participant is under anesthesia.

Participants will be followed for at least 36-months (3-years) post surgery and up to a maximum of 60-months (5-years). Follow-up data will be obtained during in-person clinic visits, and study staff who are masked to the surgical assignment will be the primary person who obtain follow-up data. Although the primary study outcome does not depend on masked participants and blinded evaluators, several important participant reported secondary aims are subject to reporting bias if the participant is aware of her study assignment. Therefore, study participants, coordinators, and nurses will be masked to the study assignment. Study surgeons and anatomic evaluators will be unmasked. Evaluators conducting the POPQ exam will be a co-investigator, fellow or other qualified nurse who did not perform the study surgery.

Surgical failure rates will be compared using survival analysis approaches appropriate for interval censored data (classic log-rank tests and survival models using a generalized linear model approach with a complementary log-log link) and secondary outcomes will be reported as rates in each group or as group means and evaluated with the appropriate parametric or nonparametric statistical tests.

Throughout the study, the PFDN Data Safety and Monitoring Committee (DSMB) will review study data and decide if the study can or cannot continue. Additionally, this study will adhere to the CONSORT guidelines for performing and reporting randomized controlled trials (Begg et al 1996). Women who are eligible but decline enrollment will be characterized in a manner consistent with CONSORT requirements.

Eligibility criteria: Inclusion Criteria:

1. Women aged 21 or older who have completed child -bearing
2. Prolapse beyond the hymen (defined as Ba, Bp, or C \> 0 cm)
3. Uterine descent into at least the lower half of the vagina (defined as point C\> -TVL/2) )
4. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
5. Desires vaginal surgical treatment for uterovaginal prolapse
6. Available for up to 60 month follow-up
7. Amenorrhea for the past 12 months from either menopause or endometrial ablation
8. Not pregnant, not at risk for pregnancy or agree to contraception if at risk for pregnancy (only applicable to the rare endometrial ablation patient)
9. Eligible for no cervical cancer screening for at least 3 years

Exclusion Criteria:

1. Previous synthetic material (placed vaginally or abdominally) to augment POP repair
2. Known previous uterosacral or sacrospinous uterine suspension
3. Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
4. Chronic pelvic pain
5. Pelvic radiation
6. Cervical elongation- defined as an expectation that the C point would be Stage 2 or greater postoperatively if a hysteropexy was performed. (Note: cervical shortening or trachelectomy is not an allowed intraoperative procedure within the hysteropexy treatment group).
7. Women at increased risk of cervical dysplasia requiring cervical cancer screening more often than every 3 years (e.g. HIV+ status, immunosuppression because of transplant related medications, Diethylstilbestrol (DES) exposure in utero, or previous treatment for cervical intraepithelial neoplasia (CIN)2, CIN3, or cancer)
8. Uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, endometrial cancer, or any uterine disease that precluded prolapse repair with uterine preservation in the opinion of the surgeon
9. Indication for ovarian removal (adnexal mass, BRCA 1/2 positivity, family history of ovarian cancer)
10. Current condition of amenorrhea caused by exogenous sex steroids or hypothalamic conditions.

Primary outcomes:
measure: Cumulative Failure
timeFrame: 6 Months through 36 Months
Secondary outcomes:
measure: At-visit Failure
timeFrame: 6 months through 36 Months
Other outcomes:
measure: Change From Baseline PFDI Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline CRADI Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline POPDI Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline UDI Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline PFIQ Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline CRAIQ Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline POPIQ Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline UIQ Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline Incontinence Severity Index
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline Functional Activity Scale
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline Body Part Pain Scale
timeFrame: 6, 12, 18, 24, 30, and 36 Months
measure: Change From Baseline Surgical Pain Scale Rest Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline Surgical Pain Scale Normal Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline Surgical Pain Scale Exercise Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline Surgical Pain Scale Worst Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline Body Image Scale
timeFrame: 6, 12, 18, 24, and 36 Months
measure: Change From Baseline PISQ-IR Sexually Active Average Score
timeFrame: 6, 12, 18, 24, and 36 Months
measure: POP-Q Ba Measurement
timeFrame: 12, 24, and 36 Months
measure: POP-Q Bp Measurement
timeFrame: 12, 24, and 36 Months
measure: POP-Q C Measurement
timeFrame: 12, 24, and 36 Months
measure: POP-Q TVL Measurement
timeFrame: 12, 24, and 36 Months
measure: PGI-I
timeFrame: 6,12, 18, 24, and 36 Months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Department of Obstetrics and Gynecology
state: Alabama
city: La Jolla
country: United States
facility: University of California at San Diego, UCSD Women's Pelvic Medicine Center
state: California
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
state: New Mexico
city: Durham
country: United States
facility: Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic, Department OB/GYN
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital, Department of Obstetrics and Gynecology
state: Pennsylvania
city: Providence
country: United States
facility: Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
state: Rhode Island
Study officials:
affiliation: University of California at San Diego, UCSD Women's Pelvic Medicine Center
name: Charles W Nager, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
name: Anthony G Visco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Heidi Harvie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic, Department OB/GYN
name: Marie Paraiso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
name: Charles R Rardin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham, Department of Obstetrics and Gynecology
name: Holly E Richter, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
name: Kate Meriwether, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Magee-Women's Hospital, Department of Obstetrics and Gynecology
name: Halina M Zyczynski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Sonia Thomas, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nager CW, Visco AG, Richter HE, Rardin CR, Komesu Y, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Sridhar A, Thomas S; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial. Am J Obstet Gynecol. 2021 Aug;225(2):153.e1-153.e31. doi: 10.1016/j.ajog.2021.03.012. Epub 2021 Mar 12.
citation: Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.
citation: Nager CW, Visco AG, Richter HE, Rardin CR, Rogers RG, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Grey S, Sridhar A, Wallace D; NICHD Pelvic Floor Disorders Network. Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1054-1065. doi: 10.1001/jama.2019.12812.