search
Back to results

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

Primary Purpose

Low Anterior Resection Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Paula Method of muscle exercises
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Anterior Resection Syndrome focused on measuring Paula Method, Sphincter sparing rectal resection, Anal incontinence, Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hadassah Medical OrganizationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Paula Method

Standard Care

Arm Description

12 weeks of the Paula Method of muscle exercises with standard care

standard care

Outcomes

Primary Outcome Measures

Change in LARS score
Comparison of the change in LARS score from baseline to the completion of 12 weeks of the intervention (within and between groups).

Secondary Outcome Measures

Full Information

First Posted
December 27, 2022
Last Updated
March 22, 2023
Sponsor
Hadassah Medical Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT05682157
Brief Title
Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial
Official Title
Use of the Paula Method of Muscle Exercises Among Patients With Low Anterior Resection Syndrome After Sphincter-sparing Rectal Resection Using an Integrative Approach
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Anterior Resection Syndrome
Keywords
Paula Method, Sphincter sparing rectal resection, Anal incontinence, Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paula Method
Arm Type
Experimental
Arm Description
12 weeks of the Paula Method of muscle exercises with standard care
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
standard care
Intervention Type
Other
Intervention Name(s)
Paula Method of muscle exercises
Intervention Description
12 weekly sessions of Paula Method of excercise
Primary Outcome Measure Information:
Title
Change in LARS score
Description
Comparison of the change in LARS score from baseline to the completion of 12 weeks of the intervention (within and between groups).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noam Shussman, MD
Phone
+972 2 6779758
Email
noams@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noam Shussman, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs