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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Constipation

Treatments: Device: Experimental toilet seat; Device: Standard toilet seat

Study type: Interventional

Funder types: Other

Identifiers

NCT02067546

TASMC-13-RY-244-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Experimental toilet seat

Experimental group

Description:

Experimental toilet seat for 1 month

Treatment:

Device: Experimental toilet seat

Standard toilet seat

Sham Comparator group

Description:

Standard toilet seat for 1 month

Treatment:

Device: Standard toilet seat