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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT02067546
First received: February 18, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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
Constipation
Device: Experimental toilet seat
Device: Standard toilet seat

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in quality of life [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02067546

Contacts
Contact: Yishai Ron, MD 97236974176 yishayr@tlvmc.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 6423966
Contact: Yishay Ron, MD    97236974176    yishayr@tlvmc.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov 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
Health Authority: Israel: National Health Institution

Keywords provided by Tel-Aviv Sourasky Medical Center:
constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014