Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders (constipation)
|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.|
|ClinicalTrials.gov Identifier: NCT02067546|
Recruitment Status : Unknown
Verified February 2014 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : February 20, 2014
Last Update Posted : February 20, 2014
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 or disease||Intervention/treatment||Phase|
|Constipation||Device: Experimental toilet seat Device: Standard toilet seat||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2015|
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
- Improvement in bowel movement frequency [ Time Frame: 2 months ]
- Improvement in quality of life [ Time Frame: 2 months ]According to QOL questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067546
|Contact: Yishai Ron, MDfirstname.lastname@example.org|
|Tel Aviv Sourasky Medical Center||Not yet recruiting|
|Tel Aviv, Israel, 6423966|
|Contact: Yishay Ron, MD 97236974176 email@example.com|