Using a laxative before surgery for pelvic prolapse in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of administering polyethylene glycol 3350, a laxative, before surgery in women undergoing procedures for pelvic organ prolapse. The study will compare the discomfort experienced during bowel movements after surgery between two groups: one receiving the laxative pre-operatively and the other receiving it post-operatively. Participants will complete questionnaires before and after their surgeries to assess their experiences. The trial is designed as a multi-institution, single-blind, randomized control study to ensure unbiased results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Where it's running

• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: David Sheyn, MD — University Hospitals Cleveland Medical Center
• Study coordinator: Gabriella M Rustia, MD
• Email: gabriella.rustia@uhhospitals.org
• Phone: 216-202-0597

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluation of the Anchorsure® Device for Treating Apical Prolapse in Women

  This study is testing a new device called Anchorsure® to see if it can help women with pelvic organ prolapse have a quicker and less painful surgery while keeping everything securely in place.

  Recruiting at 4 sites Centre Hospitalier Universitaire de Nīmes · La Rochelle and 3 other locations · NCT05836844

• Comparing biological and synthetic mesh in pelvic prolapse surgery

  This study is testing whether a new biological mesh works better than the standard synthetic mesh in surgeries for pelvic prolapse to help doctors make better choices for their patients.

  Recruiting Meander Medical Center · Amersfoort, Utrecht · NCT06430931

• Using human acellular dermal matrix for treating pelvic organ prolapse in women

  This study is testing three different surgical options to see which one works best for women with pelvic organ prolapse.

  Recruiting Phase 2 Hospital Mutua de Terrassa · Terrassa · NCT06404931

• Exploring the connection between the jaw joint and pelvis in women with certain health issues

  This study is testing if a special therapy can help women with prolapse and endometriosis-related pain by looking at how the jaw joint and pelvis are connected.

  Recruiting Poznan University of Physical Education · Poznan · NCT05978414

• Gut health follow-along with Peachbiotic in adults

  This single-arm study tests whether Peachbiotic taken daily for 12 weeks helps adults with gut symptoms feel better.

  Recruiting Peach Perfect · Las Vegas, Nevada · NCT07927907

• Prebiotic and Probiotic Combo for Constipation Symptoms

  This study tests whether adding 1-kestose to a probiotic (BBH112) helps adults with constipation-related symptoms see more relief and better quality of life.

  Recruiting Seoul National University Hospital · Seongnam-si, Gyeonggi-do · NCT07923279

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.