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Trial record 8 of 8 for:    pelvic pain AND NICHD

Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design (ASPIRe)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by NICHD Pelvic Floor Disorders Network
Sponsor:
Collaborators:
The Cleveland Clinic
University of Alabama at Birmingham
University of California, San Diego
Duke University
University of New Mexico
Women and Infants Hospital of Rhode Island
RTI International
University of Pennsylvania
University of Pittsburgh
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier:
NCT02676973
First received: November 30, 2015
Last updated: March 24, 2016
Last verified: March 2016
  Purpose

The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach.

The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.


Condition Intervention
Visceral Prolapse
Procedure: Open, Robotic, or Laparoscopic
Procedure: Transvaginal Native Tissue Repair
Procedure: Uphold™ LITE or Elevate™-AA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Three Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial Involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Surgical Treatment Failure [ Time Frame: Through 60 months using assessments of surgical treatment failure made every 6 months ] [ Designated as safety issue: No ]

    The participant will be considered a treatment failure if any one of the following criteria is met:

    1. Report of bothersome vaginal bulge symptoms. Bothersome vaginal bulge symptoms is defined as a positive response to Question 3 of the Pelvic Floor Distress Inventory (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 (i.e., any response other than "not at all" to the question "How much does this bother you?")
    2. re-treatment for prolapse
    3. any prolapse measure (Ba, D, Bp) is beyond the hymen (i.e. >0 cm)


Secondary Outcome Measures:
  • Predictors of treatment failure, with treatment failure being a binary outcome as defined for the Primary Outcome [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
    Identify risk factors for treatment failure including method of vault suspension, baseline degree of prolapse, age, obesity, smoking, menopausal status, estrogen use, and previous prolapse surgery.

  • Effect of treatment on how a woman feels (her perceptions and attitudes) about her body (Body Image) as measured by the mean score for each treatment group on the body image scale. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
    Describe changes in body image as measured by a validated scale (BIS) in a group of women undergoing apical repair with and without mesh and to evaluate whether or not changes in sexual function are associated with changes in body image.

  • Cost of surgical procedures as measured by mean direct and indirect costs for participants in each treatment group. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
    Data on each participant's use of medical and non-medical resources related to urologic or gynecologic conditions will be collected during the follow up period. Direct and indirect costs of the treatment of apical pelvic organ prolapse (POP) with sacral colpopexy, Native Tissue surgical repair or Transvaginal Mesh Repair and women's preference for health states for improvement in POP will be estimated.

  • Treatment arm mean levels of anatomic: Pelvic Organ Prolapse Quantification (POPQ) System values (Aa, Ap, Ba, Bp, C) determined from anatomic measures. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Proportion of participants in each treatment group with POPQ levels of C > -2/3 TVL [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Mean levels in each treatment group of maximum extent of prolapse (Defined as leading edge of prolapse-Ba, C, Bp). [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Proportion of patients within each treatment group with adequate prolapse improvement as measured by Patients Global Impression of Improvement (PGI-I) [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Mean overall prolapse symptoms using Pelvic Organ Prolapse Distress Inventory (POPDI-6) scores (sub-scale of PFDI-20) [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Length of urinary complications after surgery as measured by duration of postoperative catheterization [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Postoperative urinary success as measured by mean Urogenital Distress Inventory (UDI-6) scores (sub-scale of PFDI-20) [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Urinary dysfunction as measured by proportion of participants in each group with de novo voiding dysfunction and de novo incontinence [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Urinary incontinence as measured by proportion of participants in each group with stress, urge, or mixed incontinence [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Quality of sexual/body image after surgery as measured by mean Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) and Body Image in the Pelvic Organ Prolapse Questionnaire (BIPOP) scales in each treatment group [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Quality of sexual/body image after surgery as measured by of proportion of participants in each treatment group with de novo dyspareunia [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Bowel function measured as the Colorectal-anal Distress Inventory (CRADI-8) scores (sub-scale of PFDI-20) in each treatment group [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • General quality of life as measured by mean quality of life scales in each treatment group on 4 Short-Form Health Survey Support Loss (SF-12) total scores and physical function and mental function sub-scales [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Pelvic QOL as measured by mean Pelvic Floor Impact Questionnaires (PFIQ) score in each treatment arm [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Level of function as measure by mean Functional Activity Scale score for each treatment group [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Patient Regret/Satisfaction after surgery as measured by mean scores in each treatment group of Regret with Decision Regret Scale (DRS-PFD), and Satisfaction with Decision Scale (SDS-PFD) [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Interoperative blood loss as measured by mean estimated blood loss in each treatment group and proportion of participants in each treatment group with a blood transfusion. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Extent of Interoperative complications as measured by Dindo complication scale distribution for each treatment group [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Interoperative safety measured as the proportion of participants in each arm with listed operative complications. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Risk of mesh-related complications measured as the proportion of participants in each treatment group with mesh exposure in the vagina or mesh erosion into another organ and the classification of the intervention. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Risk of surgical pain in each treatment group measured as proportion of participants with pain captured from the modified Surgical Pain Scale, pain medication use, and location of pain with Body Part Pain Score. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Risk of post-surgical complications measured as the proportion of participants in each treatment group with de novo vaginal bleeding, atypical vaginal discharge, fistula formation, or neuromuscular problems (including groin, buttock and leg pain). [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Risk of need for additional treatment measured as the proportion of participants on each treatment arm with the need for subsequent procedures- any surgical or non-surgical treatment for pelvic floor disorders. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Risk of vaginal scarring defined measured as the proportion of participants in each treatment group with de novo scar requiring medical or surgical intervention. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
  • Rates of vaginal shortening (TVL<6cm), de novo dyspareunia, or worsening dyspareunia as measured on adverse event forms. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 363
Study Start Date: March 2016
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sacral Colpopexy
Sacral Colpopexy performed via open, robotic, or laparoscopic procedure.
Procedure: Open, Robotic, or Laparoscopic
Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or robot. The surgery is done with a permanent synthetic (man-made) mesh. The mesh is sutured (stitched) to the vagina and sacrum (tail bone) and is used as reinforcement. It provides additional support to weakened tissues and/or muscles.
Active Comparator: Transvaginal Native Tissue Repair
Transvaginal Native Tissue Repair: Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS)
Procedure: Transvaginal Native Tissue Repair
Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable sutures (stitches), to support weakened tissue and/or muscles, and attach the top of the vagina to ligaments in the pelvis (either to the sacrospinous ligament or uterosacral ligament).
Active Comparator: Apical Transvaginal Mesh Repair
Uphold™ LITE or Elevate™-AA (Anterior & Apical)
Procedure: Uphold™ LITE or Elevate™-AA
Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached to ligaments in the pelvis and is used to reinforce natural tissue and/or muscles, which are no longer able to provide support to the vagina.

Detailed Description:

The primary purpose of this three arm randomized clinical trial is to determine if apical transvaginal mesh placement is non-inferior to sacral colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse and to determine if mesh reinforced repairs performed by abdominal or vaginal approach are superior to native tissue vaginal repair. This trial has the following primary aims:

  1. To determine if Apical Transvaginal Mesh is non-inferior to Sacral Colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.
  2. To determine if Sacral Colpopexy is superior to Native Tissue Repair for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.
  3. To determine if Apical Transvaginal Mesh is superior to Native Tissue Repair for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.

Additional secondary aims include:

  1. Evaluate the development of a valid and reliable Global Composite Outcome that balances adverse events and patient-centered outcomes to anatomic definitions of failure and success.
  2. Determine the impact of preoperative frailty and mobility on surgical treatment outcomes and postoperative complications of older women following surgical correction of apical pelvic organ prolapse.
  3. Evaluate the patient's perspective about adverse events and their role in patient decision-making outcomes. The aims include comparing patient versus surgeon rankings of complication grade, outcome, expectedness and seriousness, to estimate the association between patient rankings of adverse events (AEs) with decision-making and quality of life outcomes and to determine if their perspective about AEs changes over time.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women age 21 or older
  2. Prior total hysterectomy (no cervix present)
  3. Prolapse beyond the hymen (defined as Ba, C, or Bp > 0 cm)
  4. Vaginal cuff descent into at least the lower two thirds of the vagina (defined as point C> -2/3 TVL)
  5. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
  6. Desires surgical treatment for post-hysterectomy vaginal prolapse
  7. Available for up to 60 month follow-up

Exclusion Criteria:

  1. Previous synthetic material or biologic grafts (placed vaginally or abdominally) to augment POP repair including anterior, posterior and/or apical compartments
  2. Known previous formal SSLS performed for either uterovaginal or post-hysterectomy vaginal vault prolapse *
  3. Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
  4. Unresolved chronic pelvic pain-active
  5. Prior abdominal or pelvic radiation
  6. Contraindication to any of the index surgical procedures

    • Known Horseshoe Kidney or Pelvic Mass overlying the sacrum
    • Active diverticular abscess or diverticulitis
    • Shortened vaginal length (<6 cm TVL)

      • NOTE:

        • Only documented SSLS will be an exclusion.
        • Mesh used for only mid-urethral sling will NOT be an exclusion
        • If prior POP repair is unknown and unable to be documented, subjects will be eligible based on clinician judgment. The investigator will examine and assess for evidence of mesh or graft if no evidence of mesh or graft is present on examination subject remains eligible.
  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: NCT02676973

Contacts
Contact: Shawn Menefee, MD (619) 221-6200 Shawn.A.Menefee@kp.org
Contact: Susan Meikle, MD (301) 273-8541 meikles@mail.nih.gov

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Ed Varner, MD    205-934-1704    evarner@uabmc.edu   
United States, California
University of California at San Diego Not yet recruiting
San Diego, California, United States, 92037
Contact: Charles Nager, MD    858-657-8435    cnager@ucsd.edu   
Kaiser Permanente Recruiting
San Diego, California, United States, 92110
Contact: Shawn Menefee, MD    619-221-6200    Shawn.A.Menefee@kp.org   
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Peter Jeppson, MD       peterjeppson@gmail.com   
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27707
Contact: Alison Weidner, MD    919-401-1006    alison.weidner@dm.duke.edu   
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Matthew D Barber, MD    216-445-0439    Barberm2@ccf.org   
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19118
Contact: Heidi Harvie, MD    215-662-4147    hharvie@obgyn.upenn.edu   
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Pamela Moalli, MD    412-641-6052    pmoalli@mail.magee.edu   
United States, Rhode Island
Brown/Women and Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02903
Contact: Deb Myers, MD    401-453-7560    DMyers@wihri.org   
Sponsors and Collaborators
NICHD Pelvic Floor Disorders Network
The Cleveland Clinic
University of Alabama at Birmingham
University of California, San Diego
Duke University
University of New Mexico
Women and Infants Hospital of Rhode Island
RTI International
University of Pennsylvania
University of Pittsburgh
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Chair: Shawn Menefee, MD Kaiser Permanente San Diego
  More Information

Responsible Party: NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT02676973     History of Changes
Other Study ID Numbers: 27P01  1U01HD069031-01  2U10HD041261  2U10HD054215  2U10HD041267  1U10HD069006  2U10HD054214  1U10HD069013  1U10HD069025  1U10HD069010  U10HD041263 
Study First Received: November 30, 2015
Last Updated: March 24, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by NICHD Pelvic Floor Disorders Network:
pelvic organ prolapse
POP
vault prolapse
cystocele
vaginal prolapse
post-hysterectomy vaginal prolapse

Additional relevant MeSH terms:
Prolapse
Visceral Prolapse
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on September 28, 2016