Visceral ProlapseASPIReNCT02676973
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
A study testing Open, Robotic, or Laparoscopic, Transvaginal Native Tissue Repair and Uphold™ LITE in people with Visceral Prolapse, run by NICHD Pelvic Floor Disorders Network at 10 sites in United States.
Trial summary
The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Visceral Prolapse
- What is being tested?
- Open, Robotic, or Laparoscopic, Transvaginal Native Tissue Repair and Uphold™ LITE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 10 sitesUnited States
- Study dates
- 29 Feb 2016to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27707
University of Pennsylvania
Philadelphia, Pennsylvania, 19118
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Brown/Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02903
University of California at San Diego
San Diego, California, 92037
Kaiser Permanente
San Diego, California, 92110
About this study
Official title: Three Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial Involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair
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.
Read the 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:
- 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.
- Conditions
- Visceral Prolapse
- Being tested
- Open, Robotic, or Laparoscopic, Transvaginal Native Tissue Repair, Uphold™ LITE
- Keywords
- pelvic organ prolapse, POP, vault prolapse, cystocele, vaginal prolapse, post-hysterectomy vaginal prolapse
- Medical subject headings
- Visceral Prolapse, Pelvic Organ Prolapse, Cystocele, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open, Robotic, or LaparoscopicProcedure or surgery
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 RepairProcedure or surgery
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™ LITEProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Sacral Colpopexy | Active comparator | Sacral Colpopexy performed via open, robotic, or laparoscopic procedure. Receives: Procedure: Open, Robotic, or Laparoscopic |
| Transvaginal Native Tissue Repair | Active comparator | Transvaginal Native Tissue Repair: Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS) Receives: Procedure: Transvaginal Native Tissue Repair |
| Apical Transvaginal Mesh Repair | Active comparator | Uphold™ LITE Receives: Procedure: Uphold™ LITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months through 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start29 Feb 2016
- Primary completion28 Jul 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Visceral ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- The Cleveland Clinic, University of Alabama at Birmingham, University of California, San Diego, Duke University, University of New Mexico, Women and Infants Hospital of Rhode Island, RTI International, University of Pennsylvania, University of Pittsburgh, Kaiser Permanente, University of Texas Southwestern Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Shawn Menefee, MD, Study chair, Kaiser Permanente San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676973
- Sponsor's protocol ID
- 27P01
- Other IDs
- 1U01HD069031-01, 2U10HD041261, 2U10HD054215, 2U10HD041267, 1U10HD069006, 2U10HD054214, 1U10HD069013, 1U10HD069025
- Acronym
- ASPIRe
- Status last verified
- Aug 2026
- First submitted
- 30 Nov 2015
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38776067Sung 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.
PubMed 38710268Sung 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.
PubMed 32487881Menefee 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.
PubMed 31860566
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial Involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair
- ClinicalTrials.gov ID
- NCT02676973
- Acronym / sponsor ID
- ASPIRe / 27P01
- Conditions
- Visceral Prolapse
- Keywords
- pelvic organ prolapse, POP, vault prolapse, cystocele, vaginal prolapse, post-hysterectomy vaginal prolapse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (actual)
- Lead sponsor
- NICHD Pelvic Floor Disorders NetworkResearch network
- Collaborators
- The Cleveland Clinic, University of Alabama at Birmingham, University of California, San Diego, Duke University, University of New Mexico, Women and Infants Hospital of Rhode Island, RTI International, University of Pennsylvania, University of Pittsburgh, Kaiser Permanente, University of Texas Southwestern Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 17 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sacral Colpopexy | Active comparator | Procedure: Open, Robotic, or LaparoscopicSacral Colpopexy performed via open, robotic, or laparoscopic procedure. |
| Transvaginal Native Tissue Repair | Active comparator | Procedure: Transvaginal Native Tissue RepairTransvaginal Native Tissue Repair: Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS) |
| Apical Transvaginal Mesh Repair | Active comparator | Procedure: Uphold™ LITEUphold™ LITE |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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'
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open, Robotic, or LaparoscopicSacral 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. | Procedure or surgery | Sacral Colpopexy |
| Transvaginal Native Tissue RepairTransvaginal 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). | Procedure or surgery | Transvaginal Native Tissue Repair |
| Uphold™ LITETransvaginal 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. | Procedure or surgery | Apical Transvaginal Mesh Repair |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38776067Menefee 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.
- Derived from this study: PubMed 38710268Sung 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.
- Derived from this study: PubMed 32487881Sung 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.
- Derived from this study: PubMed 31860566Menefee 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.
- Individual participant dataSharing planned: No
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Prolapse; Female, Endometriosis-related Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn Menefee, MD study chair
Kaiser Permanente San Diego
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open, Robotic, or Laparoscopic, Transvaginal Native Tissue Repair and Uphold™ LITE in people with Visceral Prolapse, run by NICHD Pelvic Floor Disorders Network at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Considered Failures (time frame: 6 months through 60 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02676973, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.