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

Not Applicable

• Conditions: Constipation
• Interventions: Device: Standard toilet seat; Device: Experimental toilet seat

• Registration Number: NCT02067546
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-18
• Last Update Submitted: 2014-02-18
• Study First Posted: 2014-02-20
• Last Update Posted: 2014-02-20
• Study Start: 2014-03
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard toilet seat	Standard toilet seat	Standard toilet seat for 1 month
Experimental toilet seat	Experimental toilet seat	Experimental toilet seat for 1 month

Primary Outcome Measures

Name	Time	Method
Improvement in bowel movement frequency	2 months

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life	2 months	According to QOL questionnaire

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel