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Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders (constipation)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center Identifier:
First received: February 18, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted

Emptying disorders are of the most common causes of constipation. An adjustable toilet seat was designed by " Shva-Nach" Ltd company, and is designed to facilitate the angle sitting position.

Its efficacy will be evaluated in the current study, on 50 volunteers who suffer from constipation and meet the Rome 3 criteria for constipation.

Condition Intervention
Device: Experimental toilet seat
Device: Standard toilet seat

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Improvement in bowel movement frequency [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Improvement in quality of life [ Time Frame: 2 months ]
    According to QOL questionnaire

Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental toilet seat
Experimental toilet seat for 1 month
Device: Experimental toilet seat
Sham Comparator: Standard toilet seat
Standard toilet seat for 1 month
Device: Standard toilet seat

Detailed Description:

Emptying disorders are of the most common causes of constipation. Laxatives are usually unsuccessful. Behavioral therapy such as anorectal biofeedback , have a limited success in most hospitals in this country. Toilet seat that lifts the legs and brings us into a sitting position closer to squatting (which is the desired physiological position) can relieve these patients in the emptying process.

The Company " Shva-Nach" Ltd. and its design team designed a seat at an angle slightly elevated and a toilet stool customized to the personal anatomy of each subject.

The purpose of the study: evaluating efficacy elevated toilet seat with a support of a brackets stool making emptying easier in patients with constipation and difficulty in emptying.

Methods: An open, randomized, crossover study in use of a toilet seat and comparing it to a standard seat.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Patients suffering from constipation and meet the criteria of Rome 3. No sub - distribution by emptying disorders or decreased stool frequency
  2. Age group 18-80 years
  3. Study population may include patients suffering from metabolic diseases such as diabetes mellitus, hypothyroidism and hypercalcemia.
  4. Patients who understand the goals of the research and collaborate

Exclusion Criteria:

  1. Patients who do not understand the goals of the research and / or unable to cooperate.
  2. women with known pregnancy - second trimester and up
  3. Patients with obesity - BMI> 35 and / or weight over 120 kg
  4. Neurological diseases - dementia, Parkinson's disease, CVA, multiple sclerosis, muscular dystrophy, spinal cord injury
  5. Disabled patients on wheelchairs.
  6. Patients with active anal fissure / fistula, active inflammation of the colon, patients after resection of the colon.
  7. Minors and no judgment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02067546

Contact: Yishai Ron, MD 97236974176

Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 6423966
Contact: Yishay Ron, MD    97236974176   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT02067546     History of Changes
Other Study ID Numbers: TASMC-13-RY-244-CTIL
Study First Received: February 18, 2014
Last Updated: February 18, 2014

Keywords provided by Tel-Aviv Sourasky Medical Center:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on May 25, 2017