Prophylactic Surgery for Prolapse Recurrence

Overseen by Julia Geynisman-Tan, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Disqualifiers: Prior prolapse surgery, Inflammatory bowel disease, Dyspareunia, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Posterior colpoperineorrhaphy, Posterior colporrhaphy, Posterior vaginal wall repair, Colpoperineorrhaphy for prolapse recurrence?

Research shows that posterior colporrhaphy, a type of surgery to repair the back wall of the vagina, can significantly improve symptoms like vaginal lump sensation and constipation in patients with posterior vaginal prolapse. Additionally, studies suggest that using surgical mesh in these procedures may reduce the chance of prolapse coming back. ^{1 2 3 4 5}

Is prophylactic surgery for prolapse recurrence generally safe for humans?

Research shows that posterior colporrhaphy, a type of surgery for prolapse, is generally safe with only minor complications like small hematomas (bruises) occurring in about 2.2% of cases. No major health issues were reported in the studies reviewed. ^{1 4 6 7 8}

How does prophylactic surgery for prolapse recurrence differ from other treatments?

Prophylactic surgery for prolapse recurrence may involve the use of non-absorbable polypropylene mesh, which is different from traditional methods like posterior colporrhaphy that often involve stitching muscles together. This mesh approach aims to provide stronger support and potentially reduce the chance of prolapse coming back, although it may carry risks like infection or erosion. ^{2 3 4 9 10}

Research Team

Julia Geynisman-Tan, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

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

Preoperative genital hiatus with valsalva/strain greater than or equal to 4cm

I speak English or Spanish.

Exclusion Criteria

You are currently pregnant.

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

Patients with a score of 7 or greater in any one muscle on the Meister Pelvic Floor Exam

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo sacrocolpopexy with or without posterior colpoperineorrhaphy

Day of surgery

1 visit (in-person)

Postoperative Recovery

Participants are monitored for postoperative pain, pain medication use, and blood loss

2 weeks

1 visit (in-person), 1 follow-up call

Follow-up

Participants are monitored for prolapse recurrence, defecatory dysfunction, and dyspareunia

1 year

2 visits (in-person)

Treatment Details

Interventions

• Posterior colpoperineorrhaphy (Procedure)

Trial Overview 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.

Participant Groups

Group I: Sacralcolpopexy with posterior colpoperineorrhaphy Active Control 1 Intervention

Group II: Sacralcolpopexy without posterior colpoperineorrhaphy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

Lynne A. Bui

University of Kansas

Chief Medical Officer since 2017

MD from the David Geffen UCLA School of Medicine, BA in Molecular and Cell Biology from University of California, Berkeley

Randy Milby

University of Kansas

Chief Executive Officer since 2017

BS in Pharmacy from The University of Kansas, MBA in Finance/Marketing from Washington University in St. Louis – Olin Business School

The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania

Collaborator

Trials

2

Recruited

200+

Findings from Research

In a study of 90 patients undergoing posterior colporrhaphy with mesh for vaginal prolapse, the procedure showed high efficacy with an 83.9% surgical correction rate at 6 months and significant improvement in common prolapse symptoms (p<0.001).

The safety profile was favorable, with only 2.2% experiencing minor hematomas and manageable cases of minor vaginal mesh protrusion, which were treated without the need for mesh removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ambispective observational study in the safety and efficacy of posterior colporrhaphy with composite Vicryl-Prolene mesh. Lim, YN., Rane, A., Muller, R.[2018]

In a study of 71 Thai women undergoing vaginal hysterectomy with sacrospinous ligament fixation (SSLF), the procedure was found to be safe and effective for preventing post-hysterectomy vaginal vault prolapse, with a low overall recurrence rate of 2.81% at 12 months.

However, there was a notable recurrence rate of anterior compartment prolapse, with 25.35% of participants experiencing this issue at the 12-month follow-up, highlighting the need for preoperative counseling and long-term monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical outcomes of sacrospinous ligament fixation at the time of vaginal hysterectomy for vaginal vault prolapse prevention: 10 years review. Bunyavejchevin, S., Songsiriphan, A., Ruanphoo, P., et al.[2023]

Transvaginal repair of rectocele is more effective than transanal repair in reducing the recurrence of posterior vaginal wall prolapse, based on two randomized trials.

While traditional posterior colporrhaphy is being replaced by fascial repairs that show similar success rates, the midline fascial plication may provide better anatomical and functional outcomes, though further controlled studies are needed to assess the effectiveness of combining sacrocolpopexy with posterior mesh interposition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical management of posterior vaginal wall prolapse: an evidence-based literature review. Maher, C., Baessler, K.[2018]

In a study of 626 women with recurrent posterior vaginal wall prolapse, those treated with non-absorbable polypropylene mesh had a higher 1-year cure rate compared to those who underwent standard posterior colporrhaphy, with an odds ratio of 2.06.

While the mesh group reported greater patient satisfaction and symptom improvement, they also experienced more minor complications, suggesting that the benefits of mesh reinforcement may outweigh the risks for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair of recurrent rectocele with posterior colporrhaphy or non-absorbable polypropylene mesh-patient-reported outcomes at 1-year follow-up. Nüssler, E., Granåsen, G., Nüssler, EK., et al.[2020]

Vaginal hysterectomy combined with anterior and posterior colporrhaphy (VH APR) is a safe and effective treatment for pelvic organ prolapse (POP), showing significant improvement in POP-Q scores at 1 year post-surgery for 610 patients studied.

The recurrence rate of POP after VH APR was 9.6%, with advanced preoperative stages (stage 3 or 4) being a significant risk factor for recurrence, indicating that earlier intervention may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of vaginal hysterectomy combined with anterior and posterior colporrhaphy for pelvic organ prolapse: a single center retrospective study. Kim, JH., Lee, SY., Chae, HD., et al.[2022]

In a study of 100 women with anterior vaginal wall prolapse, both anterior colporrhaphy and transvaginal polypropylene mesh insertion showed good anatomical outcomes after 24 months, with significant improvement in the mesh group for certain measurements.

However, the mesh group experienced a 16.4% rate of asymptomatic mesh exposure and other minor complications, indicating that while mesh insertion can improve anatomical outcomes, it may also carry risks that are not present with traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized, controlled trial of the treatment of anterior vaginal wall prolapse: medium term followup. Tamanini, JT., de Oliveira Souza Castro, RC., Tamanini, JM., et al.[2015]

Midline plication posterior repair without levatorplasty is recommended as the preferred surgical method for posterior vaginal wall prolapse, showing better objective outcomes compared to site-specific repairs, based on level 1 and 2 evidence.

There is no evidence supporting the use of mesh or biological grafts in surgeries for posterior vaginal wall prolapse, indicating that traditional repair methods are more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery for posterior vaginal wall prolapse. Karram, M., Maher, C.[2021]

Surgery for posterior vaginal wall prolapse should only be considered for symptomatic patients, with careful evaluation of bowel symptoms to prevent worsening conditions post-surgery.

The transvaginal approach is preferred over the transanal approach for repairs, and biological grafts or polypropylene meshes are not recommended due to safety concerns and lack of evidence for their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vaginal surgery and transanal approach for posterior vaginal wall prolapse: Guidelines for clinical practice]. Cour, F., Le Normand, L., Meurette, G.[2017]

In a study involving 71 women aged 42-82, the tension-free reconstruction method using polypropylene mesh for treating posterior vaginal wall prolapse and rectocele achieved a permanent reconstruction success rate of 98%.

The treatment demonstrated high efficacy with only a 10.3% rate of persistent symptoms and a low complication rate, as 81.7% of patients reported satisfaction with their outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prosthetic materials for treating posterior vaginal wall prolapse and rectocele - own experience. Stadnik, H., Kościński, TM.[2018]

Posterior colporrhaphy is the most common surgery for repairing posterior compartment defects, but traditional methods can lead to complications like dyspareunia due to narrowing of the vaginal opening.

The use of grafts to reinforce these repairs is becoming popular despite limited data on their effectiveness and potential complications, such as infection and recurrence of prolapse, highlighting the need for more rigorous clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior compartment defect repair in vaginal surgery: update on surgical techniques. Ginger, VA., Kobashi, KC.[2019]

References

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

An ambispective observational study in the safety and efficacy of posterior colporrhaphy with composite Vicryl-Prolene mesh. [2018]

2. Australia pubmed.ncbi.nlm.nih.gov

Surgical outcomes of sacrospinous ligament fixation at the time of vaginal hysterectomy for vaginal vault prolapse prevention: 10 years review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Surgical management of posterior vaginal wall prolapse: an evidence-based literature review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Repair of recurrent rectocele with posterior colporrhaphy or non-absorbable polypropylene mesh-patient-reported outcomes at 1-year follow-up. [2020]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Outcomes of vaginal hysterectomy combined with anterior and posterior colporrhaphy for pelvic organ prolapse: a single center retrospective study. [2022]

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

A prospective, randomized, controlled trial of the treatment of anterior vaginal wall prolapse: medium term followup. [2015]

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

Surgery for posterior vaginal wall prolapse. [2021]

8. France pubmed.ncbi.nlm.nih.gov

[Vaginal surgery and transanal approach for posterior vaginal wall prolapse: Guidelines for clinical practice]. [2017]

9. Poland pubmed.ncbi.nlm.nih.gov

Prosthetic materials for treating posterior vaginal wall prolapse and rectocele - own experience. [2018]

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

Posterior compartment defect repair in vaginal surgery: update on surgical techniques. [2019]