Prospective Randomized Controlled Trial of Obstructed Defecation Surgery (PROD)

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: Recruiting
• Conditions: Obstructed Defecation
• Intervention / Treatment: Procedure: Laparoscopic abdominal ventral rectopexy; Procedure: Transvaginal sacrospinous rectopexy

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghazaleh Rostami Nia, MD; Phone Number: 405-326-8143; Email: GRostamiNia@northshore.org

Study Locations

• United States
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Recruiting
      • Endeavor Health
      • Contact: Jungeun Lee, MS; Phone Number: 847-570-4729; Email: JLee5@northshore.org

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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
Postoperative pain by pain scale	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 by an assessment of pain medication use	Participants will be asked to indicate whether or not they are taking pain medication.	24 months post-operatively
Postoperative functional activity level	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	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
Pelvic Organ Prolapse Distress Inventory (POPDI)	As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete the 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
Colorectal-Anal Distress Inventory (CRADI)	As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete the 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
Urinary Distress Inventory (UDI)	As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete the 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
Pelvic floor Impact Questionnaire (PFIQ)	Participants will complete 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
Short Form 36 Health Survey Questionnaire (SF-36)	Participants will complete 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
EuroQol-5D (EQ-5D)	Participants will complete 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
Brink Scale	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

• Sponsor: NorthShore University HealthSystem
• Collaborators: University of Pittsburgh; Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): February 1, 2028

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): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EH22-284

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No