Study of Uterine Prolapse Procedures - Randomized Trial (SUPeR)
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.
Procedure: Uterosacral ligament suspension
Procedure: Uphold® LITE
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension|
- Time to treatment failure. Treatment failure is defined as any one of: Report of bothersome vaginal bulge symptoms (definition below), Re-treatment for prolapse (surgery or pessary), or Any prolapse measure (Ba, C, Bp) is beyond the hymen (i.e. >0cm) [ Time Frame: Baseline and then every six months post-surgery up to a maximum of 60 months. (i.e. 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo, 54mo, 60mo) ] [ Designated as safety issue: No ]
Bothersome vaginal bulge symptoms = positive response to Question 3 of the Pelvic Floor Distress Inventory - 20 (PFDI-20): Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? AND any degree of bother.
Participants not considered a treatment failure for the primary outcome will be considered a treatment success.
- Efficacy Outcomes [ Time Frame: Baseline and then every six months post-surgery up to a maximum of 60 months (i.e. 6 mo, 12 mo, 18 mo, 24 mo, 30 mo, 36 mo, 42 mo, 48 mo, 54 mo, 60 mo) ] [ Designated as safety issue: No ]
The efficacy of the study surgeries will be determined via collecting anatomic and functional data on participants, at the above mentioned time periods. Anatomic data will be obtained via the Pelvic Organ Prolapse Quantification (POPQ) exam. Functional data will be obtained via a number of participant-completed measures. Specific secondary outcome measures are:
- Patient perceived improvement in prolapse - PGI-I
- Prolapse change - prolapse symptoms score from POPDI-6 of the PFDI-20
- Urinary function post-operatively - UDI-6 of the PFDI-20
- Recovery of urinary function post-operatively - duration of catheterization
- Urinary function post-operatively - the Hunskaar Incontinence Severity Index
- Sexual function post-operatively - the PISQ-IR
- Post-operative bowel function-Colorectal - CRADI-8 of the PFDI-20
- General quality of life - SF-12
- Pelvic-organ related quality of life - PFIQ -7
- Functional activity - Functional Activity Assessment Scale
- Safety [ Time Frame: Baseline and then every six months post-surgery up to a maximum of 60 months (i.e. 6 mo, 12 mo, 18 mo, 24 mo, 30 mo, 36 mo, 42 mo, 48 mo, 54 mo, 60 mo) ] [ Designated as safety issue: Yes ]The safety of the study surgeries will be determined via collection of data on adverse events, such as mesh related complications (mesh exposure in the vagina, mesh erosion in the viscera, and suture exposure in the vagina and in the viscera), occurrence of additional surgery, and categorization of intra- and post-operative complications using a modification of the Dindo Classification.
- Predictors of poor outcomes [ Time Frame: Baseline and then every six months post-surgery up to a maximum of 60 months (i.e. 6 mo, 12 mo, 18 mo, 24 mo, 30 mo, 36 mo, 42 mo, 48 mo, 54 mo, 60 mo) ] [ Designated as safety issue: No ]Covariates of advance prolapse, age, obesity, smoking, menopausal status, estrogens, primary versus recurrent prolapse, and physical and functional activity as measured by the Functional Activity Scale will be evaluated to determine if they predict higher treatment failure.
- Cost-Effectiveness Analysis [ Time Frame: Baseline and then every six months post-surgery up to a maximum of 60 months (i.e. 6 mo, 12 mo, 18 mo, 24 mo, 30 mo, 36 mo, 42 mo, 48 mo, 54 mo, 60 mo) ] [ Designated as safety issue: No ]The cost-effectiveness analysis will be conducted from a payer perspective and will be expressed as incremental cost required to produce one additional unit of quality-adjusted life year (QALY). At the above time points, data will be collected on: 1) each participant's use of medical and non-medical resources related to urologic or gynecologic conditions, 2) direct and indirect costs of the treatment of each of the study surgeries, and 3) participants preference for health states for improvement in pelvic organ prolapse will be estimated.
- Body Image [ Time Frame: Baseline and then every six months post-surgery up to a maximum of 60 months (i.e. 6 mo, 12 mo, 18 mo, 24 mo, 30 mo, 36 mo, 42 mo, 48 mo, 54 mo, 60 mo) ] [ Designated as safety issue: No ]Comparison of body image scores between participants who receive each type of study surgery will be conducted. This comparison will be made from data collected via the body image scale (BIS).
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Hysteropexy
Procedure: Uphold® LITE
The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg.
Active Comparator: Hysterectomy and USLS
Vaginal hysterectomy and uterosacral ligament suspension (USLS)
Procedure: Uterosacral ligament suspension
The ULS procedure used in this protocol is a modification of the technique described by Shull.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802281
|United States, Alabama|
|University of Alabama at Birmingham, Department of Obstetrics and Gynecology|
|Birmingham, Alabama, United States, 35249-7333|
|United States, California|
|University of California at San Diego, UCSD Women's Pelvic Medicine Center|
|La Jolla, California, United States, 92037-0974|
|United States, New Mexico|
|University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology|
|Albuquerque, New Mexico, United States, 87131-0001|
|United States, North Carolina|
|Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery|
|Durham, North Carolina, United States, 27707|
|United States, Ohio|
|Cleveland Clinic, Department OB/GYN|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Magee-Women's Hospital, Department of Obstetrics and Gynecology|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Rhode Island|
|Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Charles W Nager, MD||University of California at San Diego, UCSD Women's Pelvic Medicine Center|
|Principal Investigator:||Anthony G Visco, MD||Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery|
|Principal Investigator:||Heidi Harvie, MD||University of Pennsylvania|
|Principal Investigator:||Matthew Barber, MD||Cleveland Clinic, Department OB/GYN|
|Principal Investigator:||Charles R Rardin, MD||Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery|
|Principal Investigator:||Holly E Richter, PhD, MD||University of Alabama at Birmingham, Department of Obstetrics and Gynecology|
|Principal Investigator:||Rebecca Rogers, MD||University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology|
|Principal Investigator:||Halina M Zyczynski, MD||Magee-Women's Hospital, Department of Obstetrics and Gynecology|
|Principal Investigator:||Dennis Wallace, PhD||RTI International|