Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial

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.

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Key information

Conditions

Low Anterior Resection Syndrome Behavior Behavioral Symptoms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Elimination Disorders Encopresis Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Mental Disorders Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Rectal Neoplasms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization, Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Chronic anal incontinence prior to surgery
inability to perform exercises due to cognitive or physical limitations
actively engaged in pelvic floor muscle exercises
pregnancy.

Treatment and study plan

Paula Method of muscle exercises

Other

12 weekly sessions of Paula Method of exercise

Primary outcomes

Change in LARS score

Time frame: 12 weeks

Comparison of the change in LARS score from baseline to the completion of 12 weeks of the intervention (within and between groups).

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Use of the Paula Method of Muscle Exercises Among Patients With Low Anterior Resection Syndrome After Sphincter-sparing Rectal Resection Using an Integrative Approach

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Jan 12, 2023
Registry last updated: May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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