Uterovaginal ProlapseSUPeRNCT01802281
Study of Uterine Prolapse Procedures - Randomized Trial
A study testing Uterosacral ligament suspension and Uphold® LITE in people with Uterovaginal Prolapse, run by NICHD Pelvic Floor Disorders Network at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Uterovaginal Prolapse
- What is being tested?
- Uterosacral ligament suspension and Uphold® LITE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Apr 2013to 7 Mar 2025
- 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 aged 21 or older who have completed child -bearing
- Prolapse beyond the hymen (defined as Ba, Bp, or C > 0 cm)
- Uterine descent into at least the lower half of the vagina (defined as point C> -TVL/2) )
- Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
- Desires vaginal surgical treatment for uterovaginal prolapse
- Available for up to 60 month follow-up
Show all 9Show fewer
- Amenorrhea for the past 12 months from either menopause or endometrial ablation
- Not pregnant, not at risk for pregnancy or agree to contraception if at risk for pregnancy (only applicable to the rare endometrial ablation patient)
- Eligible for no cervical cancer screening for at least 3 years
Who cannot join
- Previous synthetic material (placed vaginally or abdominally) to augment POP repair
- Known previous uterosacral or sacrospinous uterine suspension
- Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
- Chronic pelvic pain
- Pelvic radiation
- 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).
Show all 10Show fewer
- 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)
- 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
- Indication for ovarian removal (adnexal mass, BRCA 1/2 positivity, family history of ovarian cancer)
- Current condition of amenorrhea caused by exogenous sex steroids or hypothalamic conditions.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
Albuquerque, New Mexico, 87131
University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, 35249
Cleveland Clinic, Department OB/GYN
Cleveland, Ohio, 44195
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 27707
University of California at San Diego, UCSD Women's Pelvic Medicine Center
La Jolla, California, 92037-0974
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Magee-Women's Hospital, Department of Obstetrics and Gynecology
Pittsburgh, Pennsylvania, 15213
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, 02903
About this study
Official title: A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension
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.
Read the 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) 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). 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.
- Conditions
- Uterovaginal Prolapse
- Being tested
- Uterosacral ligament suspension, Uphold® LITE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterosacral ligament suspensionProcedure or surgery
The USLS procedure used in this protocol is a modification of the technique described by Shull.
Uphold® LITEProcedure or surgery
The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg.
| Study group | Role | What they receive |
|---|---|---|
| Hysteropexy | Active comparator | Uphold® LITE Receives: Procedure: Uphold® LITE |
| Hysterectomy and USLS | Active comparator | Vaginal hysterectomy and uterosacral ligament suspension (USLS) Receives: Procedure: Uterosacral ligament suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Failure
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 36 Months
Secondary outcomes (1)
At-visit Failure
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.
Measured: 6 months through 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study start1 Apr 2013
- Primary completion31 Jul 2023
- Study completion7 Mar 2025
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 (7)Papers the sponsor has linked to this study.
- Other trials for Uterovaginal 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Charles W Nager, MD, Principal investigator, University of California at San Diego, UCSD Women's Pelvic Medicine CenterAnthony G Visco, MD, Principal investigator, Duke University, Duke Division of Urogynecology and Reconstructive Pelvic SurgeryHeidi Harvie, MD, Principal investigator, University of PennsylvaniaMarie Paraiso, MD, Principal investigator, Cleveland Clinic, Department OB/GYNCharles R Rardin, MD, Principal investigator, Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive SurgeryHolly E Richter, PhD, MD, Principal investigator, University of Alabama at Birmingham, Department of Obstetrics and GynecologyKate Meriwether, MD, Principal investigator, University of New Mexico Health Sciences Center, Department of Obstetrics and GynecologyHalina M Zyczynski, MD, Principal investigator, Magee-Women's Hospital, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802281
- Sponsor's protocol ID
- PFDN-24P01
- Acronym
- SUPeR
- Status last verified
- Aug 2025
- First submitted
- 25 Feb 2013
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nager CW, Visco AG, Richter HE, Rardin CR, Meriwether K, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Sridhar A, Thomas S; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network. Sacrospinous Hysteropexy With Mesh vs Vaginal Hysterectomy for Treatment of Uterovaginal Prolapse: 10-Year Results of a Randomized Clinical Trial. JAMA Surg. 2026 Aug 1;161(8):764-774. doi: 10.1001/jamasurg.2026.2263.
PubMed 42340704Lockhart ME, Moalli PA, Richter HE, Meyer I, Weidner AC, Komesu YM, Carper B, Gantz MG; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network. MRI 2-D Parameters Associated with Native Tissue or Transvaginal Mesh Surgical Apical Prolapse Repair Failure. Int Urogynecol J. 2026 May 30:10.1007/s00192-026-06699-0. doi: 10.1007/s00192-026-06699-0. Online ahead of print.
PubMed 42217015Bradley MS, Sridhar A, Ferrante K, Andy UU, Visco AG, Florian-Rodriguez ME, Myers D, Varner E, Mazloomdoost D, Gantz MG; NICHD Pelvic Floor Disorders Network. Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension. Urogynecology (Phila). 2023 May 1;29(5):479-488. doi: 10.1097/SPV.0000000000001309. Epub 2022 Dec 23.
PubMed 36701331Napoe GS, Luchristt D, Sridhar A, Ellington D, Ridgeway B, Mazloomdoost D, Sung V, Ninivaggio C, Harvie H, Santiago-Lastra Y, Gantz MG, Zyczynski HM. Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment. Int Urogynecol J. 2023 Jan;34(1):255-261. doi: 10.1007/s00192-022-05411-2. Epub 2022 Nov 30.
PubMed 36449027Nager CW, Visco AG, Richter HE, Rardin CR, Komesu Y, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Sridhar A, Thomas S; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial. Am J Obstet Gynecol. 2021 Aug;225(2):153.e1-153.e31. doi: 10.1016/j.ajog.2021.03.012. Epub 2021 Mar 12.
PubMed 33716071Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.
PubMed 32769645Nager CW, Visco AG, Richter HE, Rardin CR, Rogers RG, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Grey S, Sridhar A, Wallace D; NICHD Pelvic Floor Disorders Network. Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1054-1065. doi: 10.1001/jama.2019.12812.
PubMed 31529008
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension
- ClinicalTrials.gov ID
- NCT01802281
- Acronym / sponsor ID
- SUPeR / PFDN-24P01
- Conditions
- Uterovaginal Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- NICHD Pelvic Floor Disorders NetworkResearch network
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Posted 22 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) 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). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysteropexy | Active comparator | Procedure: Uphold® LITEUphold® LITE |
| Hysterectomy and USLS | Active comparator | Procedure: Uterosacral ligament suspensionVaginal hysterectomy and uterosacral ligament suspension (USLS) |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women aged 21 or older who have completed child -bearing
- Prolapse beyond the hymen (defined as Ba, Bp, or C > 0 cm)
- Uterine descent into at least the lower half of the vagina (defined as point C> -TVL/2) )
- Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
- Desires vaginal surgical treatment for uterovaginal prolapse
Key exclusion criteria (10 listed)
- Previous synthetic material (placed vaginally or abdominally) to augment POP repair
- Known previous uterosacral or sacrospinous uterine suspension
- Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
- Chronic pelvic pain
- 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 |
|---|---|---|
| Uterosacral ligament suspensionThe USLS procedure used in this protocol is a modification of the technique described by Shull. | Procedure or surgery | Hysterectomy and USLS |
| Uphold® LITEThe Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg. | Procedure or surgery | Hysteropexy |
Primary outcome
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.
1 secondary outcome
At-visit Failure
Time frame: 6 months through 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42340704Nager CW, Visco AG, Richter HE, Rardin CR, Meriwether K, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Sridhar A, Thomas S; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network. Sacrospinous Hysteropexy With Mesh vs Vaginal Hysterectomy for Treatment of Uterovaginal Prolapse: 10-Year Results of a Randomized Clinical Trial. JAMA Surg. 2026 Aug 1;161(8):764-774. doi: 10.1001/jamasurg.2026.2263.
- Derived from this study: PubMed 42217015Lockhart ME, Moalli PA, Richter HE, Meyer I, Weidner AC, Komesu YM, Carper B, Gantz MG; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network. MRI 2-D Parameters Associated with Native Tissue or Transvaginal Mesh Surgical Apical Prolapse Repair Failure. Int Urogynecol J. 2026 May 30:10.1007/s00192-026-06699-0. doi: 10.1007/s00192-026-06699-0. Online ahead of print.
- Derived from this study: PubMed 36701331Bradley MS, Sridhar A, Ferrante K, Andy UU, Visco AG, Florian-Rodriguez ME, Myers D, Varner E, Mazloomdoost D, Gantz MG; NICHD Pelvic Floor Disorders Network. Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension. Urogynecology (Phila). 2023 May 1;29(5):479-488. doi: 10.1097/SPV.0000000000001309. Epub 2022 Dec 23.
- Derived from this study: PubMed 36449027Napoe GS, Luchristt D, Sridhar A, Ellington D, Ridgeway B, Mazloomdoost D, Sung V, Ninivaggio C, Harvie H, Santiago-Lastra Y, Gantz MG, Zyczynski HM. Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment. Int Urogynecol J. 2023 Jan;34(1):255-261. doi: 10.1007/s00192-022-05411-2. Epub 2022 Nov 30.
- Derived from this study: PubMed 33716071Nager CW, Visco AG, Richter HE, Rardin CR, Komesu Y, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Sridhar A, Thomas S; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial. Am J Obstet Gynecol. 2021 Aug;225(2):153.e1-153.e31. doi: 10.1016/j.ajog.2021.03.012. Epub 2021 Mar 12.
- Derived from this study: PubMed 32769645Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.
- Derived from this study: PubMed 31529008Nager CW, Visco AG, Richter HE, Rardin CR, Rogers RG, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Grey S, Sridhar A, Wallace D; NICHD Pelvic Floor Disorders Network. Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1054-1065. doi: 10.1001/jama.2019.12812.
- Individual participant dataSharing planned: No
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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.
Charles W Nager, MD principal investigator
University of California at San Diego, UCSD Women's Pelvic Medicine Center
Anthony G Visco, MD principal investigator
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Heidi Harvie, MD principal investigator
University of Pennsylvania
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterosacral ligament suspension and Uphold® LITE in people with Uterovaginal Prolapse, run by NICHD Pelvic Floor Disorders Network at 8 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 22 Mar 2021). 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?
Cumulative Failure (time frame: 6 Months through 36 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 NCT01802281, which also lists 7 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 26 Aug 2025.