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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Constipation

Intervention / Treatment
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* Device: Experimental toilet seat
* Device: Standard toilet seat


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients suffering from constipation and meet the criteria of Rome 3. No sub - distribution by emptying disorders or decreased stool frequency Age group 18-80 years Study population may include patients suffering from metabolic diseases such as diabetes mellitus, hypothyroidism and hypercalcemia. Patients who understand the goals of the research and collaborate Exclusion Criteria: Patients who do not understand the goals of the research and / or unable to cooperate. women with known pregnancy - second trimester and up Patients with obesity - BMI> 35 and / or weight over 120 kg Neurological diseases - dementia, Parkinson's disease, CVA, multiple sclerosis, muscular dystrophy, spinal cord injury Disabled patients on wheelchairs. Patients with active anal fissure / fistula, active inflammation of the colon, patients after resection of the colon. Minors and no judgment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental toilet seat<br>Experimental toilet seat for 1 month | Device: Experimental toilet seat<br> <br> |
| Sham Comparator: Standard toilet seat<br>Standard toilet seat for 1 month | Device: Standard toilet seat<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in bowel movement frequency |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life | According to QOL questionnaire | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation