Prospective Randomized Controlled Trial of Obstructed Defecation Surgery (PROD)

July 14, 2025 updated by: Ghazaleh Rostami Nia, Endeavor Health

Prospective Randomized Controlled Trial Comparing Transvaginal Rectopexy and Ventral Mesh Rectopexy for Obstructed Defecation in Pelvic Organ Prolapse (PROD Trial)

Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population.

Laparoscopic abdominal ventral rectopexy is an established surgical technique aimed at restoring rectal support in women with this condition. It is the most common surgery used nowadays to treat ODS. Transvaginal sacrospinous rectopexy, is an innovative procedure which has been shown to be safe and effective in the treatment of stool entrapment. Currently it is unknown whether one of the procedures mentioned is superior to the other regarding surgical outcomes and patient experience. The purpose of this research is to compare the outcomes of these two procedures considering their efficacy to improve symptoms.

During the study, participants will be randomized to undergo one of two procedures for treatment of inability to completely empty their bowel and/or rectal prolapse: 1) laparoscopic abdominal ventral rectopexy; 2) transvaginal sacrospinous rectopexy. Following the procedure, participants will be asked to return to the office for a follow-up visit 2-weeks, 2-, 12- and 24-months after the surgery. During each follow-up visit participants will undergo symptom evaluation, pelvic exam and transvaginal pelvic ultrasound to evaluate surgical success.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Endeavor Health
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female, between the age of 18 and 80

  2. OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14 of the Pelvic Floor Distress Inventory (PFDI):

    1. Do you feel you need to strain too hard to have a bowel movement?
    2. Do you feel you have not completely emptied your bowels at the end of a bowel movement?
    3. Does part of your bowel ever pass through the rectum and bulge outside during or after a bowel movement?
  3. Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound
  4. Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months
  5. Patient who is not pregnant and does not intend to become pregnant in the next 2 years
  6. Available for 24-months of follow-up
  7. Stated willingness to comply with all study procedures and availability for the duration of the study
  8. Able to complete study assessments, per clinician judgment
  9. Able and willing to provide independent written informed consent
  10. Stable cardiovascular and respiratory status to meet candidacy in vaginal or laparoscopic surgeries

Exclusion Criteria:

  1. Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating surgeon
  2. History of previous surgery that included any type of surgery for rectal prolapse
  3. Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program
  4. Previous adverse reaction to synthetic mesh
  5. Current cytotoxic chemotherapy or current or history of pelvic radiation therapy within 12 months
  6. History of two inpatient hospitalizations for medical comorbidities in the previous 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic abdominal ventral rectopexy
Procedure: Laparoscopic abdominal ventral rectopexy
Laparoscopic abdominal ventral rectopexy is an established surgical technique used to restore rectal support in women with obstructive defecatory syndrome (ODS). It is the most common surgery used to treat ODS. It involves a series of small cuts in the abdomen and the use of mesh to hold the rectum in the correct position.
Experimental: Transvaginal sacrospinous rectopexy
Procedure: Transvaginal sacrospinous rectopexy
Transvaginal sacrospinous rectopexy is an innovative procedure which has shown to be safe and effective in the treatment of stool entrapment. This is a mesh-free and vaginal route procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Rectal Hypermobility Measured Via Ultrasound
Time Frame: 24 months post-operatively
The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).
24 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Floor Distress Inventory (PFDI) - POPDI
Time Frame: 24 months post-operatively
As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete prolapse symptoms assessments using pelvic organ prolapse distress inventory (POPDI). The symptoms will be measured on a scale of 0, present, to 4, quite a bit. A higher score will indicate a higher symptom burden.
24 months post-operatively
Pelvic Floor Distress Inventory (PFDI) - CRADI
Time Frame: 24 months post-operatively
As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete colorectal symptoms assessments using colorectal anal distress inventory (CRADI). The symptoms will be measured on a scale of 0, present, to 4, quite a bit. A higher score will indicate a higher symptom burden.
24 months post-operatively
Pelvic Floor Distress Inventory (PFDI) - UDI
Time Frame: 24 months post-operatively
As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete urinary symptoms assessments using urinary distress inventory (UDI). The symptoms will be measured on a scale of 0, present, to 4, quite a bit. A higher score will indicate a higher symptom burden.
24 months post-operatively
Postoperative Pain Measured by Pain Scale
Time Frame: 24 months post-operatively
Participants will complete the pain scale. No pain will indicate the best outcome whereas the most intense pain imaginable will indicate the worst outcome.
24 months post-operatively
Postoperative Pain Measured by Pain Medication Use
Time Frame: 24 months post-operatively
Participants will complete an assessment of pain medication use.
24 months post-operatively
Postoperative Functional Activity Level
Time Frame: 24 months post-operatively
Participants will complete the Activity Assessment Scale which measures functional activity. The activity level will be measured on a scale of no difficulty, a little difficulty, some difficulty, a lot of difficulty, not able to do it, and did not do it for other reasons.
24 months post-operatively
Global Improvement in Bladder Function
Time Frame: 24 months post-operatively
Participants will complete the Patient Global Impression of Improvement. The improvement will be measured on a scale of very much better, much better, a little better, no change, a little worse, much worse, and very much worse.
24 months post-operatively
Quality of Life Measured by PFIQ
Time Frame: 24 months post-operatively
Participants will complete pelvic floor impact questionnaire (PFIQ), a condition-specific health-related quality of life questionnaire. The measurement will be on a scale of 0, not at all, to 3, quite a bit. Higher scores indicate greater impact.
24 months post-operatively
Quality of Life Measured by SF-36
Time Frame: 24 months post-operatively
Participants will also complete short form health survey (SF-36), which measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Higher scores indicate better health status.
24 months post-operatively
Quality of Life Measured by EQ-5D
Time Frame: 24 months post-operatively
Participants will complete EuroQol-5D (EQ-5D), an instrument that evaluates quality of life on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The measurement will be on a scale of 1 to 5.
24 months post-operatively
Pelvic Muscle Strength
Time Frame: 24 months post-operatively
Participants will complete the Brink Scale, a digital assessment of pelvic floor muscle strength. It consists of 3 separate 4-point rating scales for pressure, vertical finger displacement, and duration.
24 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endeavor Health

Collaborators

University of Pittsburgh
Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Ghazaleh Rostami Nia, MD, Endeavor Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH22-284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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