What side effects are associated with this type of intervention?

Common side effects of surgical treatments for Pelvic Organ Prolapse, such as Posterior Colporrhaphy and Perineorrhaphy, include pain, infection, bleeding, and urinary complications. There is also a risk of dyspareunia (painful intercourse), recurrence of prolapse, and anesthesia-related complications. Long-term outcomes can vary, and some patients may need additional surgeries.

What prior FDA approvals exist?

The FDA has approved various surgical and non-surgical treatments for Pelvic Organ Prolapse (POP). Surgical options similar to posterior colporrhaphy and perineorrhaphy, which focus on narrowing the genital hiatus, include procedures like sacrocolpopexy and transvaginal mesh implants. These treatments aim to provide structural support to the pelvic organs. Non-surgical options include pessaries and pelvic floor muscle training. Each treatment option is chosen based on the severity of the prolapse, patient health, and specific anatomical considerations.

What other types of research exist?

Promising novel alternatives for treating Pelvic Organ Prolapse include minimally invasive sacrocolpopexy, which can be performed laparoscopically or robotically. This procedure has shown good outcomes in terms of anatomical correction and functional results. Additionally, the use of bioabsorbable materials and advanced mesh techniques are being explored to improve patient outcomes and reduce complications.

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Procedure

Minimally Invasive Sacrocolpopexy for Pelvic Organ Prolapse (MERIT Trial)

N/A

Waitlist Available

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planning a surgical repair of POP with minimally invasive sacrocolpopexy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12 months postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing extra surgeries to tighten the vaginal opening after a primary surgery for women with pelvic organ prolapse. The goal is to see if these extra steps help keep the vaginal opening smaller over time.

Who is the study for?

This trial is for women with pelvic organ prolapse who have a genital hiatus size between 4.0 and 7.5cm and are planning to undergo minimally invasive sacrocolpopexy surgery.

What is being tested?

The study compares the effect of adding a Level III support procedure at the end of a sacrocolpopexy surgery on reducing enlarged genital hiatuses, using transperineal ultrasound to measure outcomes.

What are the potential side effects?

Potential side effects may include discomfort or complications from surgical procedures such as posterior colporrhaphy or perineorrhaphy, and risks associated with minimally invasive surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am planning a minimally invasive surgery for pelvic organ prolapse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12 months postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 12 months postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12 months postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enlarged Genital Hiatus at 6 months postoperatively

Secondary study objectives

Composite prolapse recurrence

Dyspareunia postoperatively

Levator Hiatal Area

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SacrocolpopexyExperimental Treatment2 Interventions

This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair.

Group II: Sacrocolpopexy and concomitant level III support procedureActive Control3 Interventions

This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Minimally Invasive Sacrocolpopexy

2020

N/A

~100

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pelvic Organ Prolapse (POP) treatments, such as Posterior Colporrhaphy and Perineorrhaphy, work by surgically narrowing the genital hiatus to restore normal pelvic anatomy. These procedures involve suturing the posterior vaginal wall and perineal body to provide better support to the pelvic organs. This is important for POP patients as it can alleviate symptoms like vaginal bulging, discomfort, and urinary incontinence, thereby improving their overall quality of life.