Surgical Treatments for Prolapse

(ASPIRe Trial)

Recruiting at 9 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NICHD Pelvic Floor Disorders Network

Disqualifiers: Previous grafts, Chronic pelvic pain, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

360 Participants Needed

Trial Summary

What is the purpose of this trial?

The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach. The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the treatment Apical Transvaginal Mesh, Sacral Colpopexy, Uphold™ LITE for prolapse?

Research shows that the Uphold LITE mesh system is effective in treating pelvic organ prolapse, with studies indicating positive clinical outcomes and patient satisfaction over both short and medium-term follow-ups. ^{1 2 3 4 5}

Is the Uphold™ LITE system safe for treating prolapse?

The Uphold™ LITE system has been studied for safety, with some reports of mesh-related complications and the need for additional surgeries. However, many patients have reported positive outcomes over the long term. ^{3 5 6 7 8}

How does the Uphold™ LITE treatment for prolapse differ from other treatments?

The Uphold™ LITE treatment is unique because it uses a mesh system for vaginal colposuspension, which provides support to the pelvic organs through a minimally invasive transvaginal approach. This differs from other treatments like sacral colpopexy, which involves attaching mesh to the sacrum (lower back bone) and can have complications such as infections. ^{1 2 5 9 10}

Research Team

Shawn Menefee, MD

Principal Investigator

Kaiser Permanente San Diego

Eligibility Criteria

This trial is for women over 21 with symptomatic vaginal prolapse after a hysterectomy, who feel a bulge or something falling out and want surgery. They must be able to follow up for up to 5 years. Those without a cervix but with significant vaginal cuff descent are eligible.

Inclusion Criteria

I am a woman aged 21 or older.

Exclusion Criteria

Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess

I cannot undergo certain surgeries due to health risks.

I currently have an infection in my digestive tract.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo one of three surgical treatments: Sacral Colpopexy, Transvaginal Mesh Repair, or Native Tissue Repair

6 months

Multiple visits for surgical procedure and initial recovery

Follow-up

Participants are monitored for safety, effectiveness, and complications post-surgery

60 months

Regular follow-up visits at 6, 12, 24, 36, 48, and 60 months

Treatment Details

Interventions

• Apical Transvaginal Mesh
• Sacral Colpopexy
• Uphold™ LITE

Trial Overview The study compares three surgical treatments for post-hysterectomy apical prolapse: transvaginal native tissue repair, sacral colpopexy using mesh (open, robotic, or laparoscopic), and Apical Transvaginal Mesh. It aims to see if there's a difference in treatment failure between the methods over time.

Participant Groups

Group I: Transvaginal Native Tissue Repair Active Control 1 Intervention

Transvaginal Native Tissue Repair: Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS)

Group II: Sacral Colpopexy Active Control 1 Intervention

Sacral Colpopexy performed via open, robotic, or laparoscopic procedure.

Group III: Apical Transvaginal Mesh Repair Active Control 1 Intervention

Uphold™ LITE

Who Is Running the Clinical Trial?

NICHD Pelvic Floor Disorders Network

Lead Sponsor

Trials

16

Recruited

4,900+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

RTI International

Collaborator

Trials

201

Recruited

942,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Laparoscopic uterosacral ligament suspension versus vaginal colposuspension using the Uphold Lite™ mesh system: clinical outcome and patient satisfaction. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial. [2020]

3. Singapore pubmed.ncbi.nlm.nih.gov

Polypropylene anterior-apical single-incision UPHOLD-LITE mesh surgery in women with severe pelvic organ prolapse: Outcome at 53 months follow up. [2023]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of the single-incision uphold system for pelvic organ prolapse repair. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Vaginal Colposuspension Using the Uphold Lite Mesh System versus Transvaginal Hysterectomy with Uterosacral Ligament Suspension for Treatment of Apical Prolapse: A Comparative Study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment of apical vaginal prolapse with minimal mesh repair (Uphold): patient-reported long-term outcomes and mesh-related complications. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Morbidity of a Single Incision Transvaginal Mesh to Correct Apical Prolapse. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A novel transvaginal approach to correct recurrent apical prolapse after failed sacral colpopexy: case series. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Sacral colpopexy followed by refractory Candida albicans osteomyelitis and discitis requiring extensive spinal surgery. [2021]