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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02067546
Acronym
constipation
Enrollment
50
Registered
2014-02-20
Start date
2014-03-31
Completion date
Unknown
Last updated
2014-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

constipation

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.

Interventions

DEVICEExperimental toilet seat
DEVICEStandard toilet seat

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Improvement in bowel movement frequency2 months

Secondary

MeasureTime frameDescription
Improvement in quality of life2 monthsAccording to QOL questionnaire

Countries

Israel

Contacts

Primary ContactYishai Ron, MD
yishayr@tlvmc.gov.il97236974176

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026