Prophylactic Surgery for Prolapse Recurrence

Overseen By Julia Geynisman-Tan, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

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

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a procedure called posterior colpoperineorrhaphy (also known as posterior colporrhaphy or posterior vaginal wall repair) to standard prolapse repair surgery can help prevent prolapse recurrence. Prolapse occurs when pelvic organs, such as the bladder or uterus, drop from their normal position. The trial compares two groups: one receiving only the standard surgery and the other receiving the surgery plus the additional procedure. Women experiencing noticeable prolapse symptoms and undergoing minimally-invasive surgery may be suitable candidates for this trial.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance prolapse treatment options.

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 prior data suggests that this surgical technique is safe?

Research has shown that posterior colpoperineorrhaphy, a surgery to repair weaknesses in the vaginal walls, is generally safe but carries some risks. Studies indicate a high success rate for this surgery, ranging from 76% to 96%, meaning many patients experience positive outcomes.

However, as with any surgery, complications may occur in about 2% to 21% of cases. These issues can vary, but most patients manage the surgery well.

Considering both the potential benefits and risks is important when deciding to join a trial involving this surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for prolapse recurrence that often involve only sacralcolpopexy, researchers are exploring the addition of posterior colpoperineorrhaphy. This surgical approach is unique because it focuses on reinforcing the vaginal wall and perineum, which could potentially reduce the chances of prolapse recurring. The combination of these two procedures might offer a more comprehensive repair by addressing multiple anatomical support structures at once. Researchers are excited about this because it could lead to improved long-term outcomes and reduce the need for additional surgeries.

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

This trial will compare sacralcolpopexy with and without posterior colpoperineorrhaphy. Research has shown that posterior colpoperineorrhaphy, a surgery to fix pelvic organ prolapse, succeeds in 76% to 96% of cases, leading many patients to feel much better afterward. However, studies have not clearly demonstrated that adding mesh to this surgery provides extra benefits. Overall, patients undergoing pelvic organ prolapse surgery usually report high satisfaction and fewer symptoms, indicating good long-term results. This treatment generally proves effective, with most patients experiencing an improved quality of life after surgery. ^{2 3 5 6 7}

Who Is on the Research Team?

Julia Geynisman-Tan, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 am a woman aged 18 or older.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Posterior colpoperineorrhaphy

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.

How Is the Trial Designed?

Group I: Sacralcolpopexy without posterior colpoperineorrhaphy Active Control 1 Intervention

Group II: Sacralcolpopexy with posterior colpoperineorrhaphy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

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

Collaborator

Trials

2

Recruited

200+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24142058/

Surgery for Posterior Vaginal Wall Prolapse To date, no studies have shown any benefit of mesh overlay or augmentation of a suture repair for posterior vaginal wall prolapse (grade B).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9270303/

Long-term outcome after routine surgery for pelvic organ ... The subjective cure rate after primary POP operations is high, with reduced symptoms and satisfied patients regardless of compartment.

3. emedicine.medscape.com emedicine.medscape.com/article/276259-treatment

Pelvic Organ Prolapse Treatment & Management The success rate of traditional posterior vaginal repair ranges from 76-96%. The success rate for site-specific defect repair with posterior ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/000293789190503J

Posterior colporrhaphy and perineorrhaphy: Separate and ... Posterior colporrhaphy and perineorrhaphy: Separate and distinct operations. Posterior vaginal repair is often poorly understood and ineffectively performed. ...

5. pelviperineology.org pelviperineology.org/articles/vaginal-reconstruction-effectiveness-and-safety-comparison-of-anterior-versus-posterior-pelvic-floor-compartment-reinforcement-with-partially-absorbable-mini-mesh-implant-in-500-cases-of-apical-pelvic-organ-prolapse/doi/PPj.2025.44.01.2024-9-1

Vaginal reconstruction effectiveness and safety Excellent anatomical and quality of life outcomes were seen in patients treated with the seratom PA MR MN® mini-mesh system for POP, according to this current ...

6. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/23324-colporrhaphy

Colporrhaphy: Purpose, Procedure, Results & Recovery Colporrhaphy is a surgery used to fix weaknesses in your vaginal walls. It's a treatment for pelvic organ prolapse (POP).

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29502352/

Surgery for women with posterior compartment prolapse If 2% of women have complications after transvaginal repair, then between 2% and 21% are likely to have complications after transanal repair.