NCT05682157Completed
Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial
Use of the Paula Method of Muscle Exercises Among Patients With Low Anterior Resection Syndrome After Sphincter-sparing Rectal Resection Using an Integrative Approach
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the usefulness of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 27 Dec 2022
- Start date
- 21 Mar 2023
- Primary completion date
- 11 Jan 2026
- Lead sponsor
- Hadassah Medical Organization
- Diseases
- Colorectal cancer
- NCT number
- NCT05682157
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 21 Mar 2023 to the primary completion date, 11 Jan 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic anal incontinence prior to surgery
Other
- inability to perform exercises due to cognitive or physical limitations
- actively engaged in pelvic floor muscle exercises
- pregnancy.
Who the study is looking for
- patients 6-18 months post restorative surgery (either resection with a primary functional anastomosis or after the closure of a temporary ileostomy following curative surgery for rectal cancer) and, if applicable, at least one month post last adjuvant chemotherapy treatment
- LARS score of 21 or greater
- age 18 or older
- able to read and write in Hebrew or English
- able and willing to comply with the study requirements.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hadassah Medical Organization Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.