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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05682157

Enrollment

Registered

2023-01-12

Start date

2023-03-21

Completion date

2026-01-11

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Anterior Resection Syndrome

Keywords

Paula Method, Sphincter sparing rectal resection, Anal incontinence, Rectal Cancer

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.

Interventions

OTHERPaula Method of muscle exercises

12 weekly sessions of Paula Method of exercise

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Israel

Contacts

PRINCIPAL_INVESTIGATORNoam Shussman, MD

Hadassah Medical Organization

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026