What side effects are associated with this type of intervention?

Common treatments for uterine prolapse, such as prophylactic posterior colpoperineorrhaphy, can have several side effects. These may include pain, infection, bleeding, and urinary tract infections. There is also a risk of recurrence of prolapse, bowel dysfunction, and complications related to the surgical mesh if used. Long-term outcomes can include chronic pain and the need for repeat surgeries. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments directly analogous to prophylactic posterior colpoperineorrhaphy for uterine prolapse. However, surgical interventions such as mesh-augmented repairs have been commonly used and studied for pelvic organ prolapse, including uterine prolapse. The FDA has approved various types of surgical mesh for transvaginal repair of pelvic organ prolapse, although some products have been subject to scrutiny and recalls due to safety concerns. Non-surgical treatments, such as pessaries and pelvic floor muscle training, are also commonly used but do not require FDA approval. For a detailed and personalized treatment plan, patients should consult with their healthcare provider.

What other types of research exist?

Promising novel alternatives to Prophylactic Posterior Colpoperineorrhaphy for uterine prolapse patients include the use of mesh-augmented apical prolapse repair techniques, such as laparoscopic or robotic sacrocolpopexy, which provide strong support to the vaginal apex. Additionally, the use of biologic grafts and advanced synthetic meshes with improved biocompatibility and reduced risk of complications are being explored. Minimally invasive approaches, including transvaginal and laparoscopic methods, are also gaining traction due to their reduced recovery times and lower complication rates.

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Prophylactic Surgery for Prolapse Recurrence

N/A

Recruiting

Led By Julia Geynisman-Tan, M.D

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Symptomatic prolapse (stage II or greater) undergoing minimally-invasive sacrocolpopexy with Restorelle ultra lightweight mesh

Be older than 18 years old

Must not have

Patient has inflammatory bowel disease (Crohn's, Ulcerative Colitis)

Patient has had prior prolapse surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying whether adding an extra surgical step to a common prolapse repair surgery helps or causes more problems. It targets women undergoing surgery for vaginal prolapse. The extra step aims to provide more support but might also cause more pain.

Who is the study for?

This trial is for women over 18 with symptomatic prolapse (stage II or greater) who are undergoing a specific minimally-invasive surgery using Restorelle mesh and have a genital opening of at least 4cm when straining. Participants must speak English or Spanish. Women who are pregnant, had previous prolapse surgery, suffer from inflammatory bowel disease, have certain pelvic floor muscle conditions, or experience pain during intercourse cannot join.

What is being tested?

The REDUCE Trial is testing if adding an extra surgical step called prophylactic posterior colpoperineorrhaphy to the standard mesh-augmented apical prolapse repair can prevent the recurrence of uterine prolapse in patients.

What are the potential side effects?

Potential side effects may include discomfort at the surgical site, infection risk, bleeding complications, and possible changes in sexual function due to the additional posterior colpoperineorrhaphy procedure.

Eligibility Criteria

Inclusion Criteria

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

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I have a noticeable pelvic organ prolapse and will undergo a specific minimally-invasive surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have inflammatory bowel disease (Crohn's or Ulcerative Colitis).

Select...

I have had surgery for organ prolapse before.

Select...

I am planning to have a Burch procedure.

Select...

I experience pain during sexual intercourse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pelvic Organ Prolapse Quantification (POP-Q) System

Secondary study objectives

Defecatory Dysfunction

Dyspareunia

Surgical and Perioperative Events: Blood Loss

+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

Active Control

Group I: Sacralcolpopexy with posterior colpoperineorrhaphyActive Control1 Intervention

Group II: Sacralcolpopexy without posterior colpoperineorrhaphyActive Control1 Intervention

0 / 5Eligibility 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

The most common treatments for uterine prolapse involve surgical interventions aimed at restoring the normal anatomical position of the uterus and supporting pelvic structures. One such treatment is the prophylactic posterior colpoperineorrhaphy, which involves the preventive repair of the posterior vaginal wall and perineum. This procedure is often combined with mesh-augmented apical prolapse repair to enhance surgical outcomes by providing additional support to the pelvic floor, thereby reducing the risk of recurrence. These treatments are crucial for uterine prolapse patients as they aim to alleviate symptoms such as pelvic pressure, urinary incontinence, and discomfort, ultimately improving the patient's quality of life and functional outcomes.