Surgical Treatments for Prolapse

(ASPIRe Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different surgical options for women who have experienced vaginal prolapse after a hysterectomy. The goal is to compare three surgical methods: two types of mesh repairs (Apical Transvaginal Mesh and Uphold™ LITE) and one using a patient’s own tissue. Researchers aim to determine which option best prevents the prolapse from recurring. Women who have had a hysterectomy, experience uncomfortable bulging sensations, and seek surgery to address their post-hysterectomy prolapse may be suitable candidates for this study. Participants will be monitored for up to five years to track outcomes. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance surgical options for future patients.

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.

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

Research has shown that both Apical Transvaginal Mesh and Sacral Colpopexy are generally safe, though they carry some risks. Serious complications occur in about 4.3% of Apical Transvaginal Mesh cases, with reported issues such as bladder injuries and significant bleeding. The mesh can occasionally become exposed or cause injuries to the bladder or bowel, though these instances are uncommon.

For Sacral Colpopexy, whether performed through open surgery, robotic, or laparoscopic methods, research indicates it is a safe and effective option. The success rate is high, with studies showing effectiveness in nearly 89.3% of cases. Complications are rare, but as with any surgery, risks exist.

Both treatments have undergone extensive study, and while they are generally well-tolerated, understanding the potential risks can aid in making an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical treatments for prolapse because they each offer unique approaches to addressing the condition. The Apical Transvaginal Mesh Repair, using Uphold™ LITE, offers a minimally invasive option that could potentially provide better support and durability compared to traditional methods. Sacral Colpopexy, which can be performed through open, robotic, or laparoscopic procedures, presents flexibility in surgical technique, potentially leading to fewer complications and faster recovery. Transvaginal Native Tissue Repair, including Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS), focuses on using the body's own tissues, which may reduce the risk of foreign body reactions. Each of these approaches is being explored to enhance the outcomes and safety for individuals with prolapse.

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

This trial will compare different surgical treatments for prolapse. Studies have shown that Sacral Colpopexy, performed through open surgery, robotic assistance, or small incisions (laparoscopic), is highly effective for treating pelvic organ prolapse. Success rates for this procedure range from 74% to 100%, making it a widely recognized top choice. In this trial, Sacral Colpopexy is one of the treatment options evaluated.

Another treatment option in this trial is Apical Transvaginal Mesh repairs, such as the Uphold™ LITE, which have a success rate of about 72.4% and a low rate of requiring additional surgery for recurring problems. Both types of mesh repairs generally work well for many patients, with Sacral Colpopexy usually achieving a higher success rate. Research suggests that mesh repairs are more effective than using the body's own tissue, providing a strong option for those considering surgery for prolapse. ^{1 2 5 6 7}

Who Is on the Research Team?

Shawn Menefee, MD

Principal Investigator

Kaiser Permanente San Diego

Are You a Good Fit for This Trial?

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

Shortened vaginal length (<6 cm TVL)

I cannot undergo certain surgeries due to health risks.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

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

Long-term outcomes of pelvic organ prolapse repair using a ... Optimal apical segment outcome was 95% in the single- compared to 83.3% in the multicenter study (p < 0.001). POP recurrence in the anterior and ...

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

Polypropylene anterior-apical single-incision UPHOLD ... Sacrospinous ligament fixation has been a reliable vaginal procedure to correct apical prolapse with success rate of 78–96 % [1]. However, this fixation is ...

3. 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 ...

4. fda.gov fda.gov/media/122860/download

Surgical Mesh for Transvaginal Repair of Pelvic Organ ... BSC stated that Uphold LITE data was comparable to native tissue repair. (NTR) across all analyses for the primary composite efficacy endpoint, which included ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1028455921000310

The efficacy and complications of using transvaginal mesh ... This review showed both the high treatment efficacy and low complication rate of TVM usage for the short-term treatment of POP in Taiwan.

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. fda.gov fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh

FDA's Activities: Urogynecologic Surgical Mesh The panel concluded that to support a favorable benefit/risk, surgical mesh for transvaginal repair of prolapse should be superior to native ...