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

Last updated: March 12, 2025
Sponsor: Hadassah Medical Organization
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Paula Method of muscle exercises

Clinical Study ID

NCT05682157
RCT-PAULA-LARS-HMO-CTIL
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • patients 6-18 months post restorative surgery (either resection with a primaryfunctional anastomosis or after the closure of a temporary ileostomy followingcurative surgery for rectal cancer) and, if applicable, at least one month post lastadjuvant 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

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

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: Paula Method of muscle exercises
Phase:
Study Start date:
March 21, 2023
Estimated Completion Date:
October 01, 2026

Connect with a study center

  • Hadassah Medical Organization

    Jerusalem,
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petach Tikva,
    Israel

    Site Not Available

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