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Laxative
Laxative for Pelvic Prolapse Surgery
Phase 4
Recruiting
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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week post-operative, 2 weeks post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week post-operative, 2 weeks post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PAC-SYM
Secondary study objectives
Doses of PEG used
Rescue laxative use
Satisfaction with pain after surgery
+1 moreSide effects data
From 2017 Phase 4 trial • 276 Patients • NCT030605123%
Flatulence
2%
Nausea
2%
Abdominal pain
1%
Urinary tract infection
1%
Abdominal pain upper
1%
Diarrhoea
1%
Vertigo
1%
Gastroenteritis
1%
Laceration
1%
Abdominal distension
1%
Vomiting
1%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
PEG 3350
Movantik
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
330 Previous Clinical Trials
391,612 Total Patients Enrolled
David Sheyn, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
6 Previous Clinical Trials
440 Total Patients Enrolled