Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

NCT06159777 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY20231417
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the use of a laxative before surgery in women having surgery to fix pelvic prolapse that do not have constipation. The main question it aims to answer is: Does use of a laxative before surgery lessen the discomfort of bowel movements after surgery? Participants will be asked to complete questionnaires before and after surgery. Researchers will compare using the laxative before and after surgery versus only after surgery to see if there is less discomfort with bowel movements after surgery.

Conditions

Constipation; Surgical Procedure, Unspecified; Prolapse; Female

Keywords

postoperative constipation; minimally invasive surgery; apical prolapse; prolapse

Outcome Measures

Primary Outcomes (1)

• PAC-SYM

  Patient assessment of constipation symptoms (PAC-SYM) is a validated 12-item questionnaire with reported average score 0-4.

  Pre-operative, 1 week post-operative, 2 weeks post-operative

Secondary Outcomes (5)

• PAC-QOL: Patient assessment of constipation quality of life measure

  Pre-operative, 2 weeks post-operative

• Time to first bowel movement

  1 week post-operative

• Doses of PEG used

  1 week post-operative, 2 weeks post-operative

• Rescue laxative use

  1 week post-operative, 2 weeks post-operative

• Satisfaction with pain after surgery

  1 week post-operative

Study Arms (2)

Pre-operative

EXPERIMENTAL

Participants will be instructed to take 17 grams of powder Polyethylene glycol 3350 (PEG) every day starting 3 days prior to scheduled surgery date and continue to take 17 grams of PEG every day for 7 days following the day of surgery. Participants will be allowed to titrate up or down the amount of PEG used as needed and instructed to record all doses of PEG used.

Drug: Polyethylene Glycol 3350

Post-operative

ACTIVE COMPARATOR

Participants will be instructed to take 17 grams of powder PEG\* every day for 7 days starting the day of surgery. Participants will be allowed to titrate up or down the amount of PEG used as needed and instructed to record all doses of PEG used.

Drug: Polyethylene Glycol 3350

Interventions

Polyethylene Glycol 3350 DRUG

\*Polyethylene glycol 3350 (PEG) will be used within it's FDA indication and dosing for constipation. Each 17-gram dose of PEG is to be mixed in 8oz of liquid.

Also known as: Miralax

Post-operative; Pre-operative

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients assigned female sex at birth undergoing an apical prolapse procedure including: sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, or colpocleisis. Planned urogynecologic procedure may include hysterectomy, adnexectomy, colporrhaphy, perineorrhaphy, or treatment of stress urinary incontinence.
• Planning to undergo primary procedure as above via minimally invasive route: vaginal or laparoscopic (including robotic-assisted). Including those that have an unplanned conversion intraoperatively of minimally invasive route to open laparotomy.

You may not qualify if:

• Diagnosis of irritable bowel syndrome, inflammatory bowel disease, slow transit constipation, obstructed defecation, or symptomatic constipation at time of study screening and recruitment. (Slow transit constipation and obstructed defecation defined as per American Gastroenterological Association 2013 constipation statement. Symptomatic constipation defined as any of the following: Bristol Stool Scale score of 1 or 2, PAC-SYM score greater than 1.0, self-reported 2 or less bowel movements per week.)
• Current use of pharmacologic laxative agent ≥1x/week (prescription or OTC) for the treatment of constipation symptoms
• Allergy or intolerance to polyethylene glycol 3350
• Planning to undergo surgery via laparotomy
• Scheduled for any concurrent non-urogynecologic procedure, ex abdominoplasty
• History of large bowel resection, surgical treatment of constipation, or anal sphincter surgery
• History of sacral neuromodulation
• Current or prior radiation therapy to the abdomen or pelvis
• Current or prior diagnosis of malignancy
• Unable to provide informed consent

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Constipation; Prolapse

Interventions

polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• David Sheyn, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 7, 2023
• Study Start: June 5, 2024
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)