Laxative for Pelvic Prolapse Surgery

Overseen By Gabriella M Rustia, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University Hospitals Cleveland Medical Center

Must not be taking: Laxatives

Disqualifiers: Irritable bowel syndrome, Inflammatory bowel disease, Constipation, Allergy to polyethylene glycol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking a laxative before pelvic prolapse surgery can ease bowel movements post-surgery. Researchers compare two groups: one takes the laxative, polyethylene glycol 3350 (PEG), before and after surgery, while the other takes it only after surgery. Women without constipation undergoing certain minimally invasive pelvic prolapse surgeries might be suitable for this study. Participants will complete questionnaires about their experiences before and after surgery. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using a laxative at least once a week for constipation, you cannot participate in the trial.

What is the safety track record for Polyethylene Glycol 3350?

Research has shown that polyethylene glycol 3350, commonly known as MiraLAX, is generally safe for use. In one study with 304 participants experiencing chronic constipation, 52% found polyethylene glycol 3350 effective, and any side effects were mild and manageable. Another study found that daily use of this laxative was safe and effective over 24 weeks. Since polyethylene glycol 3350 is already used to treat constipation, it is known to be well-tolerated. This makes it a promising option for easing discomfort after pelvic prolapse surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Polyethylene Glycol 3350 (PEG) for pelvic prolapse surgery because it offers a flexible and proactive approach to managing post-operative bowel function. Unlike traditional laxatives that are typically administered only after surgery, PEG can be started pre-operatively, which may help patients maintain regularity and comfort throughout the surgical process. Additionally, PEG allows for personalized dosing, enabling patients to adjust the amount they take based on their individual needs, potentially improving patient satisfaction and outcomes.

What evidence suggests that using a laxative before pelvic prolapse surgery could lessen post-operative bowel movement discomfort?

This trial will compare the effects of Polyethylene Glycol 3350 (PEG 3350) when used before and after pelvic prolapse surgery. Studies have shown that PEG 3350 improves bowel movements. In one study with 304 patients, 52% of those using PEG reported better results compared to those who did not use it. Another study found that people using PEG needed less additional medication for relief. This evidence suggests that PEG 3350 can ease bowel movements, potentially reducing discomfort after pelvic prolapse surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

David Sheyn

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a patient assigned female at birth and am scheduled for a pelvic organ prolapse surgery with additional urogynecologic procedures.

I am scheduled for a surgery that will start with a less invasive approach.

Exclusion Criteria

Allergy or intolerance to polyethylene glycol 3350

I have been diagnosed with cancer before.

I have been diagnosed with a bowel disorder such as IBS or constipation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative

Participants in the experimental group take 17 grams of PEG every day starting 3 days prior to scheduled surgery date

3 days

1 visit (in-person) for surgery preparation

Post-operative

Participants take 17 grams of PEG every day for 7 days starting the day of surgery. Participants can adjust the dose as needed and record all doses used.

1 week

1 visit (in-person) for surgery, follow-up via questionnaires

Follow-up

Participants are monitored for constipation symptoms and other outcomes using questionnaires at 1 and 2 weeks post-operative

2 weeks

Questionnaires at 1 and 2 weeks post-operative

What Are the Treatments Tested in This Trial?

Interventions

• Polyethylene Glycol 3350

Trial Overview 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.

How Is the Trial Designed?

Group I: Pre-operative Experimental Treatment 1 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-operative Active Control 1 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.

Polyethylene Glycol 3350 is already approved in United States, Canada, European Union for the following indications:

Approved in United States as MiraLAX for:

• Constipation
• Bowel preparation for colonoscopy or surgery

Approved in Canada as Polyethylene Glycol 3350 for:

• Constipation
• Bowel preparation for colonoscopy or surgery

Approved in European Union as Macrogol 3350 for:

• Constipation
• Faecal impaction
• Bowel preparation for colonoscopy or surgery

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Published Research Related to This Trial

Polyethylene glycol 3350 (MiraLAX) is an effective and safe osmotic laxative for treating chronic constipation in both children and adults, supported by 21 clinical studies involving 1949 patients.

The American College of Gastroenterology has given polyethylene glycol 3350 a grade A recommendation for its ability to improve stool frequency and consistency, indicating strong clinical support for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal. Zurad, EG., Johanson, JF.[2019]

In a study involving 151 constipated but otherwise healthy outpatients, Braintree polyethylene glycol (PEG) laxative significantly increased bowel movement frequency compared to a placebo, with an average of 4.5 movements per week in the PEG group versus 2.7 in the placebo group by week 2.

The PEG laxative was found to be safe, with no significant differences in laboratory results or adverse effects between the treatment and placebo groups, indicating its suitability for short-term use in treating constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. DiPalma, JA., DeRidder, PH., Orlando, RC., et al.[2022]

In a study involving 156 patients with chronic constipation, PEG3350 plus electrolytes (PEG3350 + E) significantly increased the frequency of spontaneous bowel movements compared to placebo, demonstrating its efficacy in resolving constipation.

The long-term use of PEG3350 + E over 52 weeks was well tolerated, with only mild gastrointestinal side effects reported, indicating its safety for chronic use in managing constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene glycol 3350 plus electrolytes for chronic constipation: a 2-week, randomized, double-blind, placebo-controlled study with a 52-week open-label extension. Nakajima, A., Shinbo, K., Oota, A., et al.[2020]

In a study involving 311 patients, including 117 elderly individuals, polyethylene glycol 3350 (MiraLAX) was found to be safe and effective for treating chronic constipation over a 12-month period, with 80-88% of patients reporting successful treatment outcomes.

The treatment was associated with mild to moderate gastrointestinal side effects, such as diarrhea and nausea, but there were no significant changes in blood chemistry or hematology, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label study of chronic polyethylene glycol laxative use in chronic constipation. Di Palma, JA., Cleveland, MV., McGowan, J., et al.[2018]

In a study of 304 patients with chronic constipation, PEG 3350 (MiraLAX) was found to be significantly more effective than placebo, with 52% of PEG users achieving treatment success compared to only 11% of those on placebo (P < 0.001).

The study demonstrated that PEG laxative is safe for long-term use, as there were no significant differences in adverse events or laboratory findings compared to placebo, although some gastrointestinal side effects like diarrhea and nausea were reported more frequently with PEG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Dipalma, JA., Cleveland, MV., McGowan, J., et al.[2022]

A 7-year-old child developed acute kidney injury and altered mental status after using generic PEG 3350, suggesting possible contamination with ethylene glycol, which can lead to serious health issues.

The child's condition improved after treatment, highlighting the importance of recognizing potential contamination in PEG 3350 products, especially when symptoms like metabolic acidosis and kidney injury occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol 3350 Crystal Nephropathy in Association With Glomerular Mesangial Immunoglobin A Deposition. Aly, R., Acharya, R., Zeng, X., et al.[2022]

In a study involving 23 patients with constipation, daily treatment with 17 g of polyethylene glycol (PEG) laxative significantly increased bowel movement frequency to once per day compared to a placebo, which resulted in about one bowel movement every two days.

The PEG treatment not only improved bowel movement frequency but also enhanced patients' subjective symptoms related to constipation, with no significant adverse effects observed in blood chemistry or other health markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. Cleveland, MV., Flavin, DP., Ruben, RA., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-4-constipation-1-2024-2565a

Laxative for Pelvic Prolapse Surgery In a study of 304 patients with chronic constipation, PEG 3350 (MiraLAX) was found to be significantly more effective than placebo, with 52% of PEG users ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01691742?term=DOCUSATE&viewType=Table&rank=9

MiraLAX Versus Placebo to Prevent Constipation ... This is a randomized double-blind placebo-controlled clinical trial of MiraLAX versus placebo in women undergoing pelvic reconstructive surgery receiving ...

3. gpm.amegroups.org gpm.amegroups.org/article/view/10013/html

Scoping review of evidence-based postoperative ... A survey of Danish gynecologists regarding post-operative restrictions after uncomplicated anterior or posterior vaginal prolapse repair found ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3460325/

Consensus statement AIGO/SICCR diagnosis and ... In patients treated with PEG, there are also lower rates of rescue medication use and flatulence. One trial showed that PEG was more effective ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9481403/

Polyethylene Glycol 3350 in the Treatment of Chronic ... Once-daily polyethylene glycol 3350 demonstrated substantial and sustained efficacy and safety over 24 weeks in patients with chronic idiopathic constipation.