Paula Method Muscle Exercises in Patients With Low Anterior Resection Syndrome After Sphincter Sparing Rectal Resection: A Feasibility Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Improvement in LARS (Low Anterior Resection Syndrome) Score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Improvement in LARS (Low Anterior Resection Syndrome) Score
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported