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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT02067546
First Posted: February 20, 2014
Last Update Posted: February 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
February 18, 2014
February 20, 2014
February 20, 2014
March 2014
December 2015   (Final data collection date for primary outcome measure)
Improvement in bowel movement frequency [ Time Frame: 2 months ]
Same as current
No Changes Posted
Improvement in quality of life [ Time Frame: 2 months ]
According to QOL questionnaire
Same as current
Not Provided
Not Provided
 
Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders
Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Constipation
  • Device: Experimental toilet seat
  • Device: Standard toilet seat
  • Experimental: Experimental toilet seat
    Experimental toilet seat for 1 month
    Intervention: Device: Experimental toilet seat
  • Sham Comparator: Standard toilet seat
    Standard toilet seat for 1 month
    Intervention: Device: Standard toilet seat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Not Provided
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT02067546
TASMC-13-RY-244-CTIL
No
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP