Low Anterior Resection SyndromeNCT05682157
Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial
A study testing Paula Method of muscle exercises in people with Low Anterior Resection Syndrome, run by Hadassah Medical Organization at 2 sites in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Paula Method of muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesIsrael
- Study dates
- 21 Mar 2023to 11 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Chronic anal incontinence prior to surgery
- inability to perform exercises due to cognitive or physical limitations
- actively engaged in pelvic floor muscle exercises
- pregnancy.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Organization
Jerusalem
Rabin Medical Center
Petah Tikva
About this study
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
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.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Paula Method of muscle exercises
- Keywords
- Paula Method, Sphincter sparing rectal resection, Anal incontinence, Rectal Cancer
- Medical subject headings
- Low Anterior Resection Syndrome, Encopresis, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paula Method of muscle exercisesOther
12 weekly sessions of Paula Method of exercise
| Study group | Role | What they receive |
|---|---|---|
| Paula Method | Experimental | 12 weeks of the Paula Method of muscle exercises with standard care Receives: Other: Paula Method of muscle exercises |
| Standard Care | No intervention | standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start21 Mar 2023
- Primary completion11 Jan 2026
- Study completion11 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noam Shussman, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682157
- Sponsor's protocol ID
- RCT-PAULA-LARS-HMO-CTIL
- Status last verified
- May 2026
- First submitted
- 27 Dec 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05682157
- Acronym / sponsor ID
- RCT-PAULA-LARS-HMO-CTIL
- Conditions
- Low Anterior Resection Syndrome
- Keywords
- Paula Method, Sphincter sparing rectal resection, Anal incontinence, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 11 Jan 2026 (actual)
- Study completion
- 11 Jan 2026 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paula Method | Experimental | Other: Paula Method of muscle exercises12 weeks of the Paula Method of muscle exercises with standard care |
| Standard Care | No intervention | –standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Chronic anal incontinence prior to surgery
- inability to perform exercises due to cognitive or physical limitations
- actively engaged in pelvic floor muscle exercises
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paula Method of muscle exercises12 weekly sessions of Paula Method of exercise | Other | Paula Method |
Primary outcome
Change in LARS score
Time frame: 12 weeks
Comparison of the change in LARS score from baseline to the completion of 12 weeks of the intervention (within and between groups).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
Related trials for Low Anterior Resection Syndrome
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
Not yet recruiting
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
Not yet recruiting
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Low Anterior Resection Syndrome (LARS)
Recruiting
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
Rectal Cancer, Fecal Incontinence and Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noam Shussman, MD principal investigator
Hadassah Medical Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paula Method of muscle exercises in people with Low Anterior Resection Syndrome, run by Hadassah Medical Organization at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LARS score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.