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Laxative

Pre-operative for Uterine Prolapse

Phase 4
Waitlist Available
Led By David Sheyn, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week post-operative, 2 weeks post-operative
Awards & highlights

Study Summary

This trial aims to see if giving women a laxative before surgery for pelvic prolapse reduces discomfort with bowel movements after surgery. Participants will complete questionnaires before and after surgery to compare the effects of using

Who is the study for?
This trial is for women who are planning to have minimally invasive surgery (vaginal or laparoscopic, including robotic-assisted) to correct pelvic prolapse. It includes those who might need an unplanned switch to open surgery during the procedure. Participants should be undergoing procedures like sacrocolpopexy or uterosacral ligament suspension and may also have additional related surgeries.Check my eligibility
What is being tested?
The study tests whether taking a laxative called Polyethylene Glycol 3350 before pelvic prolapse surgery can reduce discomfort in bowel movements post-surgery compared to only using it after the operation. Women will fill out questionnaires about their bowel movement comfort levels before and after surgery.See study design
What are the potential side effects?
Polyethylene Glycol 3350 is a laxative that could cause side effects such as bloating, gas, upset stomach, dizziness, or increased thirst if taken before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week post-operative, 2 weeks post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week post-operative, 2 weeks post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PAC-SYM
Secondary outcome measures
Doses of PEG used
PAC-QOL: Patient assessment of constipation quality of life measure
Rescue laxative use
+2 more

Side effects data

From 2017 Phase 4 trial • 276 Patients • NCT03060512
6%
Abdominal pain
4%
Diarrhoea
4%
Abdominal pain upper
3%
Flatulence
2%
Headache
1%
Bronchitis
1%
Drug withdrawal syndrome
1%
Dry mouth
1%
Defaecation urgency
1%
Cough
1%
Nausea
1%
Non-cardiac chest pain
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Movantik
PEG 3350

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pre-operativeExperimental Treatment1 Intervention
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.
Group II: Post-operativeActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polyethylene Glycol 3350
2023
Completed Phase 4
~510

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
318 Previous Clinical Trials
340,011 Total Patients Enrolled
1 Trials studying Uterine Prolapse
320 Patients Enrolled for Uterine Prolapse
David Sheyn, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
6 Previous Clinical Trials
444 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"The information available on clinicaltrials.gov indicates that the investigation is not currently seeking participants. Although initially posted on August 1st, 2024 and last revised on April 10th, 2024, this trial is presently inactive in terms of participant recruitment. It's noteworthy that there are a total of 185 ongoing studies actively looking for eligible individuals to enroll at present."

Answered by AI

Is the research trial open to individuals who are younger than 60 years old?

"For enrollment in this study, individuals aged between 18 and 89 are sought. Other trials cater specifically to participants under 18 or over 65 years old with a total of 32 and 144 trials respectively available for these age groups."

Answered by AI

Which specific individuals are considered the ideal candidates for inclusion in this clinical trial?

"In this clinical trial, 74 patients aged between 18 and 89 who are presently dealing with uterine prolapse can enroll. Eligible participants must be preparing for the specified primary procedure through a minimally invasive approach such as vaginal or laparoscopic (including robotic-assisted), including cases where an initially planned minimally invasive surgery converts to open laparotomy during operation. Specifically, individuals born biologically female undergoing apical prolapse procedures like sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, or colpocleisis qualify for inclusion. Planned urogynec"

Answered by AI

Does Pre-operative have approval from the FDA?

"Based on our assessment at Power, the safety rating for Pre-operative procedures was scored as 3. This is attributed to its Phase 4 status denoting official approval of this therapeutic approach."

Answered by AI

Who else is applying?

What site did they apply to?
University Hospitals Cleveland Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
David Sheyn 2024. "Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06159777.
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~49 spots leftby Feb 2025
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