Surgical Procedures for Uterovaginal Prolapse

(SUPeR Trial)

No longer recruiting at 7 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NICHD Pelvic Floor Disorders Network

Disqualifiers: Chronic pelvic pain, Pelvic radiation, Uterine abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical methods for treating uterovaginal prolapse, a condition where the uterus and vaginal walls slip out of place. It compares the effectiveness and safety of a mesh-supported procedure called Uphold® LITE hysteropexy with a traditional surgery involving uterus removal and uterosacral ligament suspension. Women experiencing a bothersome bulge and seeking vaginal surgery for prolapse might be suitable candidates. The study aims to evaluate the effectiveness of these treatments over three years. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future prolapse treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study reported a serious complication rate of 4.3% for the Uphold® LITE mesh used in pelvic organ prolapse, including issues such as bladder injuries and heavy bleeding. Despite these risks, it effectively supports vaginal structures in women with prolapse.

Research has shown that uterosacral ligament suspension (USLS) is a safe and effective treatment for pelvic organ prolapse. Studies indicate it achieves very good results, with less than 1% of patients requiring additional surgery.

Both Uphold® LITE and USLS present their own risks and benefits. Uphold® LITE may cause serious complications for a small number of patients, while USLS is generally considered safe with a low likelihood of needing further surgeries. These factors are important to consider when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments for uterovaginal prolapse because they offer distinct approaches compared to traditional options like pessaries or standard surgical repairs. The Uphold® LITE system provides a minimally invasive solution with a lightweight mesh that supports weakened pelvic tissues, potentially reducing recovery time and complications. On the other hand, uterosacral ligament suspension (USLS) involves a vaginal hysterectomy to secure the pelvic organs, offering a more anatomical restoration. These innovative methods give patients alternatives that may enhance comfort and outcomes compared to conventional procedures.

What evidence suggests that this trial's treatments could be effective for uterovaginal prolapse?

Research has shown that the Uphold LITE mesh, a treatment in this trial, effectively treats pelvic organ prolapse. Studies have found cure rates of 96.7% after one year and 95.4% after three years. Another treatment option in this trial, uterosacral ligament suspension (USLS), also yields positive results. Studies report excellent outcomes for USLS, with less than 1% of patients requiring additional surgery. Both treatments in this trial successfully address prolapse issues, offering different surgical options with promising results. ^{2 3 6 7 8}

Who Is on the Research Team?

Kate Meriwether, MD

Principal Investigator

University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology

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

Charles R Rardin, MD

Principal Investigator

Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery

Sonia Thomas, DrPH

Principal Investigator

RTI International

Holly E Richter, PhD, MD

Principal Investigator

University of Alabama at Birmingham, Department of Obstetrics and Gynecology

Marie Paraiso, MD

Principal Investigator

Cleveland Clinic, Department OB/GYN

Heidi Harvie, MD

Principal Investigator

University of Pennsylvania

Halina M Zyczynski, MD

Principal Investigator

Magee-Women's Hospital, Department of Obstetrics and Gynecology

Are You a Good Fit for This Trial?

This trial is for women over 21 who've finished having children, are not pregnant, and can follow up for up to 5 years. They should have uterovaginal prolapse beyond the hymen with bothersome symptoms but no history of certain pelvic treatments or conditions that would exclude them from safe participation.

Inclusion Criteria

Available for up to 60 month follow-up

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)

Exclusion Criteria

I have received radiation therapy to my pelvis.

My cervix is expected to be low in position after a specific pelvic surgery.

I am at high risk for cervical issues and need screenings more often due to factors like HIV, immune suppression, DES exposure, or past treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either vaginal hysterectomy with uterosacral ligament suspension or mesh hysteropexy suspension for uterovaginal prolapse

Surgical procedure

1 visit (in-person, surgical)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with follow-up data collected during in-person clinic visits

36-60 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Uphold® LITE
• Uterosacral ligament suspension

Trial Overview The study compares two surgical methods for fixing uterine prolapse: a mesh-augmented hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension. It aims to see which method is more effective over three years.

How Is the Trial Designed?

Group I: Hysterectomy and USLS Active Control 1 Intervention

Vaginal hysterectomy and uterosacral ligament suspension (USLS)

Group II: Hysteropexy Active Control 1 Intervention

Uphold® LITE

Who Is Running the Clinical Trial?

NICHD Pelvic Floor Disorders Network

Lead Sponsor

Trials

16

Recruited

4,900+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7854402/

Long-term outcomes of pelvic organ prolapse repair using a ... The aim of this study was to compare long-term effects of high-volume surgery at a single-center to multicenter use when using a mesh-capturing device for ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0929664623004692

Polypropylene anterior-apical single-incision UPHOLD ... Objective cure rate at 1 and 3 years was high at 96.7 and 95.4 % respectively, with subjective cure of 95.1 % and 91.6 % (Fig.

3. fda.gov fda.gov/media/122867/download

BOSTON SCIENTIFIC CORPORATION Uphold LITE ... apical prolapse produced similar results within each component of the primary efficacy ... pelvic organ prolapse: results of a cohort study, Int.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01917968

NCT01917968 | Uphold LITE Post-Market Surveillance Study The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31359498/

Clinical evaluation of the Uphold LITE mesh for the surgical ... The composite success rate was 72.4% (71 of 98). The rate of reoperation for apical or anterior recurrent prolapse was 3.9% (4 of 103). Anatomical anterior or ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26874525/

Pelvic Organ Prolapse Repair Using the Uphold™ Vaginal ... Results: The overall rate of serious complications was 4.3 % (9 out of 207 patients), including 3 patients with bladder perforations, 1 with bleeding >1,000 ml, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030121152200611X

Long term surgical outcomes of vaginal colposuspension ... The aim of this study was to compare long term objective and subjective outcomes of apical prolapse repair using the Uphold Lite™ Mesh System for sacrospinous ...

8. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2819032

Apical Suspension Repair for Vaginal Vault Prolapse NTR has long been considered a safer alternative with similar subjective improvement to mesh-augmented repairs but less efficacy for anatomic ...