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NCT Number: NCT02676973

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

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. Participants will be followed for at least 36-months (3-years) post surgery and up to a maximum of 60-months (5-years) during the primary trial. Participants who complete the primary trial will be approached for consent for long-term follow-up as part of a study extension and will be followed up to a maximum of 120-months (10-years).

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Visceral Prolapse Cystocele Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Uterine Diseases Uterine Prolapse

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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:

  • 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.

  • 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.
  • 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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Open, Robotic, or Laparoscopic

Procedure

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.

Transvaginal Native Tissue Repair

Procedure

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).

Uphold™ LITE

Procedure

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 outcomes

  1. Number of Participants Considered Failures

    Time frame: 6 months through 60 Months

    Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit.

Other outcomes

  1. Change From Baseline PFDI Score

    Time frame: 6 months through 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 for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month [12, 24, 36] Score - Baseline Score).

  2. Change From Baseline CRADI Score

    Time frame: 6 months through 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 for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month [12, 24, 36] Score - Baseline Score).

  3. Change From Baseline POPDI Score

    Time frame: 6 months through 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 for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month [12, 24, 36] Score - Baseline Score).

  4. Change From Baseline UDI Score

    Time frame: 6 months through 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 for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month [12, 24, 36] Score - Baseline Score).

  5. Change From Baseline PFIQ Score

    Time frame: 6 months through 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 an overall score (range 0-300), 3 subscales (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 all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week [12, 24] Score - Baseline Score).

  6. Change From Baseline CRAIQ Score

    Time frame: 6 months through 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 an overall score (range 0-300), 3 subscales (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 all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week [12, 24] Score - Baseline Score).

  7. Change From Baseline POPIQ Score

    Time frame: 6 months through 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 an overall score (range 0-300), 3 subscales (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 all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week [12, 24] Score - Baseline Score).

  8. Change From Baseline UIQ Score

    Time frame: 6 months through 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 an overall score (range 0-300), 3 subscales (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 all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week [12, 24] Score - Baseline Score).

  9. Change From Baseline Functional Activity Scale

    Time frame: 6 months through 60 Months

    Functional Activity Scale measuring the impact of incontinence symptoms on a woman's daily activities is composed of 13 questions about normal and physically strenuous daily activities. The range of responses on the individual questions is (1) No difficulty,... (5) Not able to do it. Scores are calculated by subtracting from the maximum sum (5*13=65) the product of the mean response and number of questions, then dividing by the total range of sums (65 - 13 = 52) and multiplying by 100. The range of responses is: 0-100 with 0 (worse functionality) to 100 (Better functionality). Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  10. Change From Baseline Body Part Pain Scale

    Time frame: 6 months through 60 Months

    The Body Part Pain Scale measuring the pain experienced in the lower abdomen and pelvic region of the body is composed of 7 questions, each with a yes (1) or no (0) questions about experiencing pain followed by an intensity rating: 0 (No pain),..., 10 (Most intense). The score is calculated as the average of the responses. The range of responses is: 0-10 with 0 (No pain) to 10 (most intense pain). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  11. Change From Baseline Surgical Pain Scale Rest Score

    Time frame: 6 months through 60 Months

    The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  12. Change From Baseline Surgical Pain Scale Normal Score

    Time frame: 6 months through 60 Months

    The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  13. Change From Baseline Surgical Pain Scale Exercise Score

    Time frame: 6 months through 60 Months

    The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  14. Change From Baseline Surgical Pain Scale Worst Score

    Time frame: 6 months through 60 Months

    The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  15. Change From Baseline PISQ-IR Sexually Active Average Score

    Time frame: 6 months through 60 Months

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. The PISQ-IR Sexually Active-Average Score (SA-AVG) ranges from 0 to 5 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 6, 12, 18, 24, and 36 months and the score at baseline.

  16. Change From Baseline POP-Q Ba Measurement

    Time frame: 6 months through 60 Months

    POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C.

  17. Change From Baseline POP-Q Bp Measurement

    Time frame: 6 months through 60 Months

    POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap).

  18. Change From Baseline POP-Q C Measurement

    Time frame: 6 months through 60 Months

    POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy.

  19. Change From Baseline POP-Q TVL Measurement

    Time frame: 6 months through 60 Months

    POP-Q Total Vaginal Length (TVL) is measured in cm. It is the length of the vagina from posterior fornix to the hymen when Point C or D is reduced to its full normal position.

  20. Number of Participants With PGI-I Reported Improvement

    Time frame: 6 months through 60 Months

    The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).

Sponsors and collaborators

Lead sponsor

NICHD Pelvic Floor Disorders Network

Network

Collaborators

  • Duke University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Kaiser Permanente
  • RTI International
  • The Cleveland Clinic
  • University of Alabama at Birmingham
  • University of California, San Diego
  • University of New Mexico
  • University of Pennsylvania
  • University of Pittsburgh
  • University of Texas Southwestern Medical Center
  • Women and Infants Hospital of Rhode Island

Registry information

Official study title

Three Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial Involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair

Acronym: ASPIRe

Important dates

Study start
2016
Primary completion
2022
Study completion
2026
First posted
Feb 9, 2016
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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