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Study of Uterine Prolapse Procedures - Randomized Trial (SUPeR)

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: NCT01802281
Recruitment Status : Active, not recruiting
First Posted : March 1, 2013
Results First Posted : March 22, 2021
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
NICHD Pelvic Floor Disorders Network

Brief Summary:

The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years.

A supplemental study investigates anterior vaginal wall movement resulting from descent or rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the study arms of SUPeR.


Condition or disease Intervention/treatment Phase
Uterovaginal Prolapse Procedure: Uterosacral ligament suspension Procedure: Uphold® LITE Not Applicable

Detailed Description:

The study population will be adult women (>21 years of age) with symptomatic uterovaginal prolapse at or beyond the hymen who desire vaginal surgical management. This study is intended to be done only on women who have completed child-bearing and have an inactive uterus, defined as amenorrhea for 1 year. Therefore women will be postmenopausal or will have amenorrhea from an endometrial ablation. Amenorrhea caused from exogenous steroids, or hypothalamic disorders will not allow inclusion.

Participants will be obtained from the clinic population of each of the eight Pelvic Floor Disorders Network (PFDN) sites. Participants will be randomly assigned to have either vaginal hysterectomy and USLS or mesh hysteropexy suspension for treatment of their uterovaginal prolapse. The surgical assignment will be revealed in the operating room, after the participant is under anesthesia.

Participants will be followed for at least 36-months (3-years) post surgery and up to a maximum of 60-months (5-years). Follow-up data will be obtained during in-person clinic visits, and study staff who are masked to the surgical assignment will be the primary person who obtain follow-up data. Although the primary study outcome does not depend on masked participants and blinded evaluators, several important participant reported secondary aims are subject to reporting bias if the participant is aware of her study assignment. Therefore, study participants, coordinators, and nurses will be masked to the study assignment. Study surgeons and anatomic evaluators will be unmasked. Evaluators conducting the POPQ exam will be a co-investigator, fellow or other qualified nurse who did not perform the study surgery.

Surgical failure rates will be compared using survival analysis approaches appropriate for interval censored data (classic log-rank tests and survival models using a generalized linear model approach with a complementary log-log link) and secondary outcomes will be reported as rates in each group or as group means and evaluated with the appropriate parametric or nonparametric statistical tests.

Throughout the study, the PFDN Data Safety and Monitoring Committee (DSMB) will review study data and decide if the study can or cannot continue. Additionally, this study will adhere to the CONSORT guidelines for performing and reporting randomized controlled trials (Begg et al 1996). Women who are eligible but decline enrollment will be characterized in a manner consistent with CONSORT requirements.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension
Study Start Date : April 2013
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hysteropexy
Uphold® LITE
Procedure: Uphold® LITE
The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg.

Active Comparator: Hysterectomy and USLS
Vaginal hysterectomy and uterosacral ligament suspension (USLS)
Procedure: Uterosacral ligament suspension
The USLS procedure used in this protocol is a modification of the technique described by Shull.




Primary Outcome Measures :
  1. Cumulative Failure [ Time Frame: 6 Months through 36 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.


Secondary Outcome Measures :
  1. At-visit Failure [ Time Frame: 6 months through 36 Months ]
    Failure was defines 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 transient failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study. Similarly, the denominator number of participants for the transient failure at each visit includes all participants who were still participating in the study and attended the visit or who missed the visit but had a retreatment failure outcome prior to their missed visit.


Other Outcome Measures:
  1. Change From Baseline PFDI Score [ Time Frame: 6, 12, 18, 24, and 36 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. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  2. Change From Baseline CRADI Score [ Time Frame: 6, 12, 18, 24, and 36 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. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  3. Change From Baseline POPDI Score [ Time Frame: 6, 12, 18, 24, and 36 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. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  4. Change From Baseline UDI Score [ Time Frame: 6, 12, 18, 24, and 36 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. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  5. Change From Baseline PFIQ Score [ Time Frame: 6, 12, 18, 24, and 36 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). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  6. Change From Baseline CRAIQ Score [ Time Frame: 6, 12, 18, 24, and 36 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). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  7. Change From Baseline POPIQ Score [ Time Frame: 6, 12, 18, 24, and 36 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). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  8. Change From Baseline UIQ Score [ Time Frame: 6, 12, 18, 24, and 36 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). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  9. Change From Baseline Incontinence Severity Index [ Time Frame: 6, 12, 18, 24, and 36 Months ]
    Incontinence Severity Index measuring the severity of urinary incontinence is composed of 2 questions: frequency of leakage (0=Never,...,4=Every day/night) and amount of urine leakage (1=Drops, 2=small splashes, 3= More). The index score is calculated categorizing the product of the two responses. The range of responses is: 0 (no incontinence) to 12 (severe incontinence). Lower index scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  10. Change From Baseline Functional Activity Scale [ Time Frame: 6, 12, 18, 24, and 36 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).

  11. Change From Baseline Body Part Pain Scale [ Time Frame: 6, 12, 18, 24, 30, and 36 Months ]
    The Body Part Pain Scale measuring the 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).

  12. Change From Baseline Surgical Pain Scale Rest Score [ Time Frame: 6, 12, 18, 24, and 36 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. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  13. Change From Baseline Surgical Pain Scale Normal Score [ Time Frame: 6, 12, 18, 24, and 36 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. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  14. Change From Baseline Surgical Pain Scale Exercise Score [ Time Frame: 6, 12, 18, 24, and 36 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. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  15. Change From Baseline Surgical Pain Scale Worst Score [ Time Frame: 6, 12, 18, 24, and 36 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. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score).

  16. Change From Baseline Body Image Scale [ Time Frame: 6, 12, 18, 24, and 36 Months ]
    The Body Image Scale measuring how the subjects feel about their appearance and about any changes that may have resulted from their condition consists of 8 questions. The questions are scored from 0=Not at all,..., 3=Very much. The score is calculated by summing the responses and ranges from 0 to 24. Higher scores correspond to worse body image. Change = Month [6, 12, 18, 24, and 36] Score - Baseline Score.

  17. Change From Baseline PISQ-IR Sexually Active Average Score [ Time Frame: 6, 12, 18, 24, and 36 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.

  18. POP-Q Ba Measurement [ Time Frame: 12, 24, and 36 Months ]
    The Pelvic Organ Prolapse Quantification (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.

  19. POP-Q Bp Measurement [ Time Frame: 12, 24, and 36 Months ]
    The Pelvic Organ Prolapse Quantification (POPQ) 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).

  20. POP-Q C Measurement [ Time Frame: 12, 24, and 36 Months ]
    The Pelvic Organ Prolapse Quantification (POPQ) 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.

  21. POP-Q TVL Measurement [ Time Frame: 12, 24, and 36 Months ]
    The Pelvic Organ Prolapse Quantification (POPQ) Total Vaginal Length (TVL) is the length of the vagina from posterior fornix tothe hymen when Point C or D is reduced to its full normal position.

  22. PGI-I [ Time Frame: 6,12, 18, 24, and 36 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).



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 aged 21 or older who have completed child -bearing
  2. Prolapse beyond the hymen (defined as Ba, Bp, or C > 0 cm)
  3. Uterine descent into at least the lower half of the vagina (defined as point C> -TVL/2) )
  4. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
  5. Desires vaginal surgical treatment for uterovaginal prolapse
  6. Available for up to 60 month follow-up
  7. Amenorrhea for the past 12 months from either menopause or endometrial ablation
  8. Not pregnant, not at risk for pregnancy or agree to contraception if at risk for pregnancy (only applicable to the rare endometrial ablation patient)
  9. Eligible for no cervical cancer screening for at least 3 years

Exclusion Criteria:

  1. Previous synthetic material (placed vaginally or abdominally) to augment POP repair
  2. Known previous uterosacral or sacrospinous uterine suspension
  3. Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
  4. Chronic pelvic pain
  5. Pelvic radiation
  6. Cervical elongation- defined as an expectation that the C point would be Stage 2 or greater postoperatively if a hysteropexy was performed. (Note: cervical shortening or trachelectomy is not an allowed intraoperative procedure within the hysteropexy treatment group).
  7. Women at increased risk of cervical dysplasia requiring cervical cancer screening more often than every 3 years (e.g. HIV+ status, immunosuppression because of transplant related medications, Diethylstilbestrol (DES) exposure in utero, or previous treatment for cervical intraepithelial neoplasia (CIN)2, CIN3, or cancer)
  8. Uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, endometrial cancer, or any uterine disease that precluded prolapse repair with uterine preservation in the opinion of the surgeon
  9. Indication for ovarian removal (adnexal mass, BRCA 1/2 positivity, family history of ovarian cancer)
  10. Current condition of amenorrhea caused by exogenous sex steroids or hypothalamic conditions.

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): NCT01802281


Locations
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United States, Alabama
University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, United States, 35249
United States, California
University of California at San Diego, UCSD Women's Pelvic Medicine Center
La Jolla, California, United States, 92037-0974
United States, New Mexico
University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States, 27707
United States, Ohio
Cleveland Clinic, Department OB/GYN
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Magee-Women's Hospital, Department of Obstetrics and Gynecology
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
NICHD Pelvic Floor Disorders Network
Boston Scientific Corporation
Investigators
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Principal Investigator: Charles W Nager, MD University of California at San Diego, UCSD Women's Pelvic Medicine Center
Principal Investigator: Anthony G Visco, MD Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Principal Investigator: Heidi Harvie, MD University of Pennsylvania
Principal Investigator: Marie Paraiso, MD Cleveland Clinic, Department OB/GYN
Principal Investigator: Charles R Rardin, MD Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Principal Investigator: Holly E Richter, PhD, MD University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Principal Investigator: Yuko Komesu, MD University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
Principal Investigator: Halina M Zyczynski, MD Magee-Women's Hospital, Department of Obstetrics and Gynecology
Principal Investigator: Sonia Thomas, DrPH RTI International
  Study Documents (Full-Text)

Documents provided by NICHD Pelvic Floor Disorders Network:
Study Protocol  [PDF] October 9, 2020
Statistical Analysis Plan  [PDF] December 15, 2018

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: NCT01802281    
Other Study ID Numbers: PFDN-24P01
First Posted: March 1, 2013    Key Record Dates
Results First Posted: March 22, 2021
Last Update Posted: March 22, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical