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

NCT ID: NCT02067546

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31

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.

Conditions

Constipation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental toilet seat

Experimental toilet seat for 1 month

Group Type: EXPERIMENTAL

Experimental toilet seat

Intervention Type: DEVICE

Standard toilet seat

Standard toilet seat for 1 month

Group Type: SHAM_COMPARATOR

Standard toilet seat

Intervention Type: DEVICE

Interventions

Experimental toilet seat

Intervention Type: DEVICE

Standard toilet seat

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, Israel

Countries

Israel

Central Contacts

Yishai Ron, MD

Role: CONTACT

yishayr@tlvmc.gov.il

97236974176

Facility Contacts

Yishay Ron, MD

Role: primary

yishayr@tlvmc.gov.il

97236974176

Other Identifiers

TASMC-13-RY-244-CTIL

Identifier Type: -

Identifier Source: org_study_id