RecruitingNot ApplicableNCT05682157

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


Sponsor

Hadassah Medical Organization

Enrollment

62 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

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

Interventions

OTHERPaula Method of muscle exercises

12 weekly sessions of Paula Method of exercise


Locations(2)

Hadassah Medical Organization

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

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NCT05682157


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