Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders (constipation)
Recruitment status was Not yet recruiting
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.
|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|
- Improvement in bowel movement frequency [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Improvement in quality of life [ Time Frame: 2 months ] [ Designated as safety issue: No ]According to QOL questionnaire
|Study Start Date:||March 2014|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|