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

Constipation Clinical Trial

— constipation  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02067546
• Other study ID #: TASMC-13-RY-244-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2014
• Last updated: February 18, 2014
• Start date: March 2014

Study information

• Verified date: February 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Yishai Ron, MD
• Phone: 97236974176
• Email: yishayr[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: National Health Institution
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Device:
• Experimental toilet seat

• Standard toilet seat

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in bowel movement frequency		2 months	No
Secondary	Improvement in quality of life	According to QOL questionnaire	2 months	No