search
Back to results

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

Primary Purpose

Constipation

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Experimental toilet seat
Standard toilet seat
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental toilet seat

Standard toilet seat

Arm Description

Experimental toilet seat for 1 month

Standard toilet seat for 1 month

Outcomes

Primary Outcome Measures

Improvement in bowel movement frequency

Secondary Outcome Measures

Improvement in quality of life
According to QOL questionnaire

Full Information

First Posted
February 18, 2014
Last Updated
February 18, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02067546
Brief Title
Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders
Acronym
constipation
Official Title
Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental toilet seat
Arm Type
Experimental
Arm Description
Experimental toilet seat for 1 month
Arm Title
Standard toilet seat
Arm Type
Sham Comparator
Arm Description
Standard toilet seat for 1 month
Intervention Type
Device
Intervention Name(s)
Experimental toilet seat
Intervention Type
Device
Intervention Name(s)
Standard toilet seat
Primary Outcome Measure Information:
Title
Improvement in bowel movement frequency
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Improvement in quality of life
Description
According to QOL questionnaire
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yishai Ron, MD
Phone
97236974176
Email
yishayr@tlvmc.gov.il
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423966
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yishay Ron, MD
Phone
97236974176
Email
yishayr@tlvmc.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs