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

Not Applicable

Recruiting

• Conditions: Low Anterior Resection Syndrome
• Interventions: Other: Paula Method of muscle exercises

• Registration Number: NCT05682157
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2022-12-27
• Study First Posted: 2023-01-12
• Study Start: 2023-03-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-02-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paula Method	Paula Method of muscle exercises	12 weeks of the Paula Method of muscle exercises with standard care

Primary Outcome Measures

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

Trial Locations

Locations (2)

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel