Visceral Prolapse Clinical Trial
— ASPIReOfficial title:
Three Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial Involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair
| Verified date | April 2024 |
| Source | NICHD Pelvic Floor Disorders Network |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 360 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | July 28, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 21 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of New Mexico | Albuquerque | New Mexico |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | University of Texas Southwestern Medical Center | Dallas | Texas |
| United States | Duke University | Durham | North Carolina |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Brown/Women and Infants Hospital of Rhode Island | Providence | Rhode Island |
| United States | Kaiser Permanente | San Diego | California |
| United States | University of California at San Diego | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| NICHD Pelvic Floor Disorders Network | 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 |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Primary | 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 |