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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Post-operative Compared to Post-operative Only Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
- ClinicalTrials.gov ID
- NCT06159777
- Acronym / sponsor ID
- STUDY20231417
- Keywords
- postoperative constipation, minimally invasive surgery, apical prolapse, prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Posted 22 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative | Experimental | Drug: Polyethylene Glycol 3350Participants 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. |
| Post-operative | Active comparator | Drug: Polyethylene Glycol 3350Participants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene Glycol 3350Also: 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. | Drug | Post-operative, Pre-operative |
Primary outcome
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. Higher scores indicate more constipation symptoms
5 secondary outcomes
PAC-QOL: Patient Assessment of Constipation Quality of Life Measure
Time frame: 2 weeks post-operative
Time to First Bowel Movement
Time frame: 1 week post-operative
Doses of PEG Used
Time frame: 1 week post-operative, 2 weeks post-operative
Number of Participants With Rescue Laxative Use
Time frame: 1 week post-operative, 2 weeks post-operative
Satisfaction With Pain After Surgery
Time frame: 1 week post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Sheyn, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAC-SYM (time frame: Pre-operative, 1 week post-operative, 2 weeks post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.