ConstipationPhase 4NCT06159777
Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
A Phase 4 study testing Polyethylene Glycol 3350 in people with Constipation and Surgical Procedure, Unspecified, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Constipation, Surgical Procedure, Unspecified, Prolapse; Female
- What is being tested?
- Polyethylene Glycol 3350
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to 13 Mar 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Pre- and Post-operative Compared to Post-operative Only 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.
Read the detailed description
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)
- Being tested
- Polyethylene Glycol 3350
- Keywords
- postoperative constipation, minimally invasive surgery, apical prolapse, prolapse
- Medical subject headings
- Constipation, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol 3350Drug
Also called Miralax
*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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Polyethylene Glycol 3350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAC-SYM
Patient assessment of constipation symptoms (PAC-SYM) is a validated 12-item questionnaire with reported average score 0-4. Higher scores indicate more constipation symptoms
Measured: Pre-operative, 1 week post-operative, 2 weeks post-operative
Secondary outcomes (5)
PAC-QOL: Patient Assessment of Constipation Quality of Life Measure
PAC-QOL is a 28-item questionnaire with scores averaged ranging from 0-4 without units. Higher scores signify worse constipation symptoms.
Measured: 2 weeks post-operative
Time to First Bowel Movement
after surgery in approximate days
Measured: 1 week post-operative
Doses of PEG Used
polyethylene glycol 3350 (PEG) doses of 17 grams powder mixed in 8oz of liquid
Measured: 1 week post-operative, 2 weeks post-operative
Number of Participants With Rescue Laxative Use
Use of additional laxatives or enemas
Measured: 1 week post-operative, 2 weeks post-operative
Satisfaction With Pain After Surgery
Satisfaction with pain after surgery, 0-10 Likert scale (0=not at all satisfied, 10= completely satisfied)
Measured: 1 week post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start5 Jun 2024
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Sheyn, University Hospitals Cleveland Medical Center
- Investigators
- David Sheyn, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159777
- Sponsor's protocol ID
- STUDY20231417
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2023
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No