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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Visceral Prolapse
• Intervention / Treatment: Procedure: Open, Robotic, or Laparoscopic; Procedure: Transvaginal Native Tissue Repair; Procedure: Uphold™ LITE

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.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • San Diego, California, United States, 92110
      • Kaiser Permanente
    • San Diego, California, United States, 92037
      • University of California at San Diego
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19118
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown/Women and Infants Hospital of Rhode Island
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Considered Failures	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.	6 months through 60 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of treatment failure, with treatment failure being a binary outcome as defined for the Primary Outcome	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
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.	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Cost of surgical procedures as measured by mean direct and indirect costs for participants in each treatment group.	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Treatment arm mean levels of anatomic: Pelvic Organ Prolapse Quantification (POPQ) System values (Aa, Ap, Ba, Bp, C) determined from anatomic measures.	Mean levels in of anatomic measures of key pelvic floor metrics (Aa, Ap, Ba, Bp, C) obtained from the POPQ exam.	Baseline, 6, 12, 24, 36, 48, and 60 months
Proportion of participants in each treatment group with POPQ levels of C > -2/3 TVL	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).	Baseline, 6, 12, 24, 36, 48, and 60 months
Mean levels in each treatment group of maximum extent of prolapse (Defined as leading edge of prolapse-Ba, C, Bp).	Measures maximum extent of prolapse (defined as leading edge of prolapse - Ba, C, or Bp as measured by the POPQ).	Baseline, 6, 12, 24, 36, 48, and 60 months
Proportion of patients within each treatment group with adequate prolapse improvement as measured by Patients Global Impression of Improvement (PGI-I)	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).	Baseline, 6, 12, 24, 36, 48, and 60 months
Mean overall prolapse symptoms using Pelvic Organ Prolapse Distress Inventory (POPDI-6) scores (sub-scale of PFDI-20)	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Length of urinary complications after surgery as measured by duration of postoperative catheterization	Measures time to removal of the catheter post-operatively.	Baseline, 6, 12, 24, 36, 48, and 60 months
Postoperative urinary success as measured by mean Urogenital Distress Inventory (UDI-6) scores (sub-scale of PFDI-20)	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Urinary dysfunction as measured by proportion of participants in each group with de novo voiding dysfunction.	Measures risk of de novo voiding dysfunction at 6-month post-operative intervals.	Baseline, 6, 12, 24, 36, 48, and 60 months
Urinary incontinence as measured by proportion of participants in each group with stress, urge, or mixed incontinence	Measures risk of de novo incontinence at 6-month post-operative intervals for stress, urge, and mixed incontinence.	Baseline, 6, 12, 24, 36, 48, and 60 months
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	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Quality of sexual/body image after surgery as measured by of proportion of participants in each treatment group with de novo dyspareunia	Defined as an event of dyspareunia as listed on adverse event form.	Baseline, 6, 12, 24, 36, 48, and 60 months
Bowel function measured as the Colorectal-anal Distress Inventory (CRADI-8) scores (sub-scale of PFDI-20) in each treatment group	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
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	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Pelvic QOL as measured by mean Pelvic Floor Impact Questionnaires (PFIQ) score in each treatment arm	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Level of function as measure by mean Functional Activity Scale score for each treatment group	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
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)	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Interoperative blood loss in each treatment group.	Measured by mean estimated blood loss in each treatment group and proportion of participants in each treatment group with a blood transfusion.	Baseline, 6, 12, 24, 36, 48, and 60 months
Extent of interoperative complications in each treatment group.	Extent of interoperative complications is measured by Dindo complication scale.	Baseline, 6, 12, 24, 36, 48, and 60 months
Interoperative safety in each treatment group.	Measured as the proportion of participants in each arm with listed operative complications	Baseline, 6, 12, 24, 36, 48, and 60 months
Risk of mesh-related complications in each treatment group.	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Risk of post-surgical complications in each treatment group	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).	Baseline, 6, 12, 24, 36, 48, and 60 months
Risk of need for additional treatment/subsequent procedures for pelvic floor disorders.	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Risk of vaginal scarring requiring medical or surgical intervention in each treatment group.	Measured as the proportion of participants in each treatment group with de novo scar requiring medical or surgical intervention.	Baseline, 6, 12, 24, 36, 48, and 60 months
Rates of vaginal shortening (TVL<6cm), de novo dyspareunia, or worsening dyspareunia.	Defined as an event of vaginal shortening, de novo dyspareunia, or worsening dyspareunia as listed on adverse event forms.	Baseline, 6, 12, 24, 36, 48, and 60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline PFDI Score	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).	6 months through 60 Months
Change From Baseline CRADI Score	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).	6 months through 60 Months
Change From Baseline POPDI Score	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).	6 months through 60 Months
Change From Baseline UDI Score	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).	6 months through 60 Months
Change From Baseline PFIQ Score	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 months through 60 Months
Change From Baseline CRAIQ Score	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 months through 60 Months
Change From Baseline POPIQ Score	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 months through 60 Months
Change From Baseline UIQ Score	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 months through 60 Months
Change From Baseline Functional Activity Scale	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).	6 months through 60 Months
Change From Baseline Body Part Pain Scale	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).	6 months through 60 Months
Change From Baseline Surgical Pain Scale Rest Score	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).	6 months through 60 Months
Change From Baseline Surgical Pain Scale Normal Score	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).	6 months through 60 Months
Change From Baseline Surgical Pain Scale Exercise Score	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).	6 months through 60 Months
Change From Baseline Surgical Pain Scale Worst Score	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).	6 months through 60 Months
Change From Baseline PISQ-IR Sexually Active Average Score	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.	6 months through 60 Months
Change From Baseline POP-Q Ba Measurement	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.	6 months through 60 Months
Change From Baseline POP-Q Bp Measurement	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).	6 months through 60 Months
Change From Baseline POP-Q C Measurement	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.	6 months through 60 Months
Change From Baseline POP-Q TVL Measurement	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.	6 months through 60 Months
Number of Participants With PGI-I Reported Improvement	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).	6 months through 60 Months

Collaborators and Investigators

• Sponsor: NICHD Pelvic Floor Disorders Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pennsylvania; University of California, San Diego; University of Alabama at Birmingham; University of Pittsburgh; The Cleveland Clinic; Duke University; University of Texas Southwestern Medical Center; Kaiser Permanente; University of New Mexico; Women and Infants Hospital of Rhode Island; RTI International
• Investigators: Study Chair: Shawn Menefee, MD, Kaiser Permanente San Diego

Publications and helpful links

General Publications

• Sung VW, Menefee S, Dunivan G, Richter HE, Moalli P, Weidner A, Andy UU, Jelovsek E, Mazloomdoost D, Whitworth R, Thomas S; NICHD Pelvic Floor Disorders Network. Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial. Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):e112-e117. doi: 10.1097/SPV.0000000000000845.
• Menefee S, Richter HE, Myers D, Weidner A, Moalli P, Harvie H, Rahn D, Jeppson P, Paraiso M, Thomas S, Mazloomdoost D; NICHD Pelvic Floor Disorders Network. Design of a 3-Arm Randomized Trial for Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair: The Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial. Female Pelvic Med Reconstr Surg. 2020 Jul;26(7):415-424. doi: 10.1097/SPV.0000000000000803.
• Menefee SA, Richter HE, Myers D, Moalli P, Weidner AC, Harvie HS, Rahn DD, Meriwether KV, Paraiso MFR, Whitworth R, Mazloomdoost D, Thomas S; NICHD Pelvic Floor Disorders Network. Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial. JAMA Surg. 2024 Aug 1;159(8):845-855. doi: 10.1001/jamasurg.2024.1206.
• Sung VW, Menefee S, Richter HE, Moalli PA, Andy U, Weidner A, Rahn DD, Paraiso MF, Jeney SE, Mazloomdoost D, Gilbert J, Whitworth R, Thomas S; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Patient perspectives in adverse event reporting after vaginal apical prolapse surgery. Am J Obstet Gynecol. 2024 Aug;231(2):268.e1-268.e16. doi: 10.1016/j.ajog.2024.04.043. Epub 2024 May 6.

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2016
• Primary Completion (Actual): July 28, 2022
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimated): February 9, 2016

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: vaginal prolapse; pelvic organ prolapse; POP; vault prolapse; cystocele; post-hysterectomy vaginal prolapse
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Diseases; Gastrointestinal Diseases; Uterine Diseases; Genital Diseases, Female; Urinary Bladder Diseases; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Uterine Prolapse; Cystocele; Visceral Prolapse; Technology, Industry, and Agriculture; Automation; Technology; Robotics
• Other Study ID Numbers: 27P01; U10HD041263 (U.S. NIH Grant/Contract); 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO