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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02676973
Recruitment Status : Active, not recruiting
First Posted : February 9, 2016
Last Update Posted : March 10, 2021
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
University of Texas Southwestern Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Pelvic Floor Disorders Network

Brief Summary:

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 or disease Intervention/treatment Phase
Visceral Prolapse Procedure: Open, Robotic, or Laparoscopic Procedure: Transvaginal Native Tissue Repair Procedure: Uphold™ LITE Not Applicable

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.

1A. In the case where Apical Transvaginal Mesh is shown to be statistically significantly non-inferior to Sacral Colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years, to determine if Apical Transvaginal Mesh is superior 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (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
Study Start Date : March 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
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
Procedure: Uphold™ LITE
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.




Primary Outcome Measures :
  1. Surgical Treatment Success [ Time Frame: Up to 60 months using a survival treatment analysis approach ]

    Treatment success is the primary outcome and treatment success is defined as:

    1. Absence of bothersome bulge symptoms
    2. Absence of retreatment
    3. No prolapse past the hymen (points Ba, C, and Bp <=0 cm)


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    Mean levels in of anatomic measures of key pelvic floor metrics (Aa, Ap, Ba, Bp, C) obtained from the POPQ exam.

  5. 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 ]
    Obtained by comparing the cervical or cuff location (Point C) to the total vaginal length (TVL) from the POPQ exam obtained at 6-month post-operative intervals. A participant will be defined as positive at any time point if C > -2/3 total vaginal length (TVL).

  6. 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 ]
    Measures maximum extent of prolapse (defined as leading edge of prolapse - Ba, C, or Bp as measured by the POPQ).

  7. 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 ]
    The PGI-I is a single question form collected every 6 months that asks for a response to the question: "Check the number that best describes how your post-operative condition is now, compared with how it was before you had the surgery." The response is a 7-level Likert scale from 1 Very much better to 7 Very much worse. Adequate prolapse improve is defined as a participant response of either 1 (very much better), 2 (much better), and 3 (better).

  8. 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 ]
    The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms.

  9. Length of urinary complications after surgery as measured by duration of postoperative catheterization [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Measures time to removal of the catheter post-operatively.

  10. 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 ]
    The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms.

  11. Urinary dysfunction as measured by proportion of participants in each group with de novo voiding dysfunction. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Measures risk of de novo voiding dysfunction at 6-month post-operative intervals.

  12. 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 ]
    Measures risk of de novo incontinence at 6-month post-operative intervals for stress, urge, and mixed incontinence.

  13. 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 ]
    Mean BIPOP and PISQ-IR scores in each treatment group. The BIPOP is scored from 1 to 5, with higher scores indicating worse body image. The PISQ-IR is a 31-item questionnaire where higher scores reflect better sexual functioning.

  14. 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 ]
    Defined as an event of dyspareunia as listed on adverse event form.

  15. 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 ]
    The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms.

  16. 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 ]

    Physical component summary scale (PCS-12) will be computed at 6 month post-operative intervals using standard algorithms from the SF-12 developer.

    Mental component summary scale (MCS-12) will be computed at 6 month post-operative intervals using standard algorithms from the SF-12 developer.


  17. 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 ]
    The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman''s daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Month [12, 24, 36] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

  18. 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 ]
    The Activities Assessment Scale (AAS) score will be computed at 6 month post-operative intervals using standard scoring algorithms described by McCarthy (2005) to create a measure scaled 0 to 100 at each time point.

  19. 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 ]
    The Decision Regret Scale (DRS) measures regret after health care decision. It is a 5-item measure and the answers range from "strongly agree" to "strongly disagree" on a five point Likert scale. Scores on DRS range from 0 to 100, were higher score indicate more regret after health care decision. Satisfaction with Decision scale (SDS) is a 6-item scale measuring satisfaction with health care decisions, The scale uses a 1-5 rating (1=strongly disagree; 5 = strongly agree). Scores from these 6 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with the decision.

  20. Interoperative blood loss in each treatment group. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Measured by mean estimated blood loss in each treatment group and proportion of participants in each treatment group with a blood transfusion.

  21. Extent of interoperative complications in each treatment group. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Extent of interoperative complications is measured by Dindo complication scale.

  22. Interoperative safety in each treatment group. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Measured as the proportion of participants in each arm with listed operative complications

  23. Risk of mesh-related complications in each treatment group. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    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.

  24. Risk of surgical pain in each treatment group. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    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.

  25. Risk of post-surgical complications in each treatment group [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    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).

  26. Risk of need for additional treatment/subsequent procedures for pelvic floor disorders. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    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.

  27. Risk of vaginal scarring requiring medical or surgical intervention in each treatment group. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Measured as the proportion of participants in each treatment group with de novo scar requiring medical or surgical intervention.

  28. Rates of vaginal shortening (TVL<6cm), de novo dyspareunia, or worsening dyspareunia. [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Defined as an event of vaginal shortening, de novo dyspareunia, or worsening dyspareunia as listed on adverse event forms.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes 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 active 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676973


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
University of California at San Diego
San Diego, California, United States, 92037
Kaiser Permanente
San Diego, California, United States, 92110
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27707
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19118
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown/Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02903
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
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
University of Texas Southwestern Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Chair: Shawn Menefee, MD Kaiser Permanente San Diego
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT02676973    
Other Study ID Numbers: 27P01
1U01HD069031-01 ( U.S. NIH Grant/Contract )
2U10HD041261 ( U.S. NIH Grant/Contract )
2U10HD054215 ( U.S. NIH Grant/Contract )
2U10HD041267 ( U.S. NIH Grant/Contract )
1U10HD069006 ( U.S. NIH Grant/Contract )
2U10HD054214 ( U.S. NIH Grant/Contract )
1U10HD069013 ( U.S. NIH Grant/Contract )
1U10HD069025 ( U.S. NIH Grant/Contract )
1U10HD069010 ( U.S. NIH Grant/Contract )
U10HD041263 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
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:
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Visceral Prolapse
Prolapse
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse