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NCT Number: NCT06159777

Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

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.

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Key information

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

The purpose of this study is to evaluate if there is a difference in bother related to constipation between a pre-operative versus post-operative start of a bowel regimen for patients undergoing surgery for pelvic organ prolapse This will be a multi-institution, single-blind, randomized control trial utilizing questionnaires and chart review to evaluate effect of pre-operative bowel regimen on post-operative constipation.

  • Study team and surgeons will be blinded to group assignments, participants will not be.
  • Participants will be randomized after consent is obtained, and at least 1 week prior to planned surgery, via computer-generated blocks in a 1:1 ratio between study group (pre-operative and post-operative use) and control group (post-operative only use) of polyethylene glycol 3350 (PEG)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Miralax

Primary outcomes

  1. PAC-SYM

    Time frame: Pre-operative, 1 week post-operative, 2 weeks post-operative

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

Secondary outcomes

  1. PAC-QOL: Patient assessment of constipation quality of life measure

    Time frame: Pre-operative, 2 weeks post-operative

  2. Time to first bowel movement

    Time frame: 1 week post-operative

    after surgery in approximate hours/days

  3. Doses of PEG used

    Time frame: 1 week post-operative, 2 weeks post-operative

    polyethylene glycol 3350 (PEG) doses of 17 grams powder mixed in 8oz of liquid

  4. Rescue laxative use

    Time frame: 1 week post-operative, 2 weeks post-operative

    Use of additional laxatives or enemas

  5. Satisfaction with pain after surgery

    Time frame: 1 week post-operative

    Satisfaction with pain after surgery

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Pre- and Post-operative Compared to Post-operative Only Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2023
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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