Paula Method of Exercises in Patients With LARS Syndrome

Paula Method Muscle Exercises in Patients With Low Anterior Resection Syndrome After Sphincter Sparing Rectal Resection: A Feasibility Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05016583

Enrollment

Registered

2021-08-23

Start date

2021-10-28

Completion date

2022-07-04

Last updated

2022-10-13

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

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 feasibility of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

Interventions

OTHERPaula Method

12 weeks of Paula Method of Exercises

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Over age 18 * LARS syndrome (LARS score of 21 or higher) up to 24 months post sphincter sparing rectal resection * Able to read, understand and communicate in Hebrew

Exclusion criteria

* Pregnancy * Actively undergoing Chemotherapy or Radiation * Other causes of anal incontinence or bowel dysfunction (ex: Irritable Bowel Syndrome) * Concurrent performance of other exercise methods * Unable or unwilling to perform the Paula exercises

Design outcomes

Primary

Measure	Time frame	Description
Improvement in LARS (Low Anterior Resection Syndrome) Score	12 weeks	Decrease of in the LARS Score from baseline measurement to the end of the study measurement. The scale is based on a score of 0-42 . A score of 0-20 indicates the absence of LARS, 21-29- Minor LARS, and 30-42- Major LARS.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026