Study of Uterine Prolapse Procedures - Randomized Trial (SUPeR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by NICHD Pelvic Floor Disorders Network
Sponsor:
Collaborators:
Boston Scientific Corporation
Information provided by (Responsible Party):
dwallace, RTI International
ClinicalTrials.gov Identifier:
NCT01802281
First received: February 25, 2013
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Symptomatic Uterovaginal Prolapse at or Beyond the Hymen
Procedure: Vaginal hysterectomy and uterosacral ligament suspension (USLS)
Procedure: Uphold® LITE

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by NICHD Pelvic Floor Disorders Network:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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:

    1. Patient perceived improvement in prolapse - PGI-I
    2. Prolapse change - prolapse symptoms score from POPDI-6 of the PFDI-20
    3. Urinary function post-operatively - UDI-6 of the PFDI-20
    4. Recovery of urinary function post-operatively - duration of catheterization
    5. Urinary function post-operatively - the Hunskaar Incontinence Severity Index
    6. Sexual function post-operatively - the PISQ-IR
    7. Post-operative bowel function-Colorectal - CRADI-8 of the PFDI-20
    8. General quality of life - SF-12
    9. Pelvic-organ related quality of life - PFIQ -7
    10. 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).


Estimated Enrollment: 180
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)
Arms Assigned Interventions
Active Comparator: Hysteropexy
Uphold® LITE
Procedure: Uphold® LITE
Active Comparator: Hysterectomy and USLS
Vaginal hysterectomy and uterosacral ligament suspension (USLS)
Procedure: Vaginal hysterectomy and uterosacral ligament suspension (USLS)

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802281

Contacts
Contact: Charles Nager, MD 858-657-8435 cnager@ucsd.edu
Contact: Dennis Wallace, PhD 919-541-6271 dwallace@rti.org

Locations
United States, Alabama
University of Alabama at Birmingham, Department of Obstetrics and Gynecology Recruiting
Birmingham, Alabama, United States, 35249-7333
Contact: Velria Willis, RN,BSN,CCRC    205-975-8522    vwillis@uabmc.edu   
Principal Investigator: Holly E Richter, PhD, MD         
United States, California
University of California at San Diego, UCSD Women's Pelvic Medicine Center Recruiting
La Jolla, California, United States, 92037-0974
Contact: Joann Columbo    858-657-6827    jcolumbo@ucsd.edu   
Principal Investigator: Charles Nager, MD         
United States, New Mexico
University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology Recruiting
Albuquerque, New Mexico, United States, 87131-0001
Contact: Anne Fullilove    505-272-6391    AMFullilove@salud.unm.edu   
Principal Investigator: Rebecca Rogers, MD         
United States, North Carolina
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery Recruiting
Durham, North Carolina, United States, 27707
Contact: Mary Raynor, RN, BSN    919-401-1016    mary.raynor@duke.edu   
Principal Investigator: Anthony G Visco, MD         
United States, Ohio
Cleveland Clinic, Department OB/GYN Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ly Pung, RN, BSN    216-445-5505    pungl@ccf.org   
Principal Investigator: Matthew Barber, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michelle Kinglee    215-615-6569    kingleem@uphs.upenn.edu   
Principal Investigator: Heidi Harvie, MD         
Magee-Women's Hospital, Department of Obstetrics and Gynecology Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Judy Gruss, RN    412-641-5388    grusja@mail.magee.edu   
Principal Investigator: Halina M Zyczynski, MD         
United States, Rhode Island
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery Recruiting
Providence, Rhode Island, United States, 02903
Contact: Ann Meers, RN, CCRC    401-276-7869    ameers@wihri.org   
Principal Investigator: Charles R Rardin, MD         
Sponsors and Collaborators
NICHD Pelvic Floor Disorders Network
Boston Scientific Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: dwallace, Project Director, RTI International
ClinicalTrials.gov Identifier: NCT01802281     History of Changes
Other Study ID Numbers: PFDN-24P01
Study First Received: February 25, 2013
Last Updated: April 17, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014