- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111006
The Effect of Electronic Cleansing Toilet System (Bidet) on Anal Resting Pressure
April 26, 2010 updated by: Seoul National University Hospital
The Effect of Electronic Cleansing Toilet System (Bidet) on Anal Resting Pressure in Normal Healthy Volunteers
The purpose of this study was to evaluate the effect of Bidet on anal resting pressure with regards to various flow rates and temperatures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bidet is an electronic device spraying stream of the water for cleansing the anus and sometimes to aid defecation.
It is widely used in Korea and Japan, with the flow rate (pressure) and temperature of water varying widely among the manufacturers.
However, the effects of Bidet on anorectal function have not been studied in detail with regards to these variables.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 110-744
- Department of Surgery, Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy volunteer
Exclusion Criteria:
- anal disease pregnancy any medical disease that is necessary to treat psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pressure before and after applying the bidet
Time Frame: after 1minute
|
After the anal resting pressure was stabilized at sitting position, water stream of the bidet was applied to anus for 1 minute under various settings of different pressures (4, 8, 16, 20 gram force, gf), temperatures (24oC vs. 38oC), types of stream (narrow vs. wide) (Total time for experiment at individual subject was about two hours)
|
after 1minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The temperature of rectum
Time Frame: after 1minute
|
The temperature probe was supposed to be placed in the rectum with manometry catheter and to prove the possibility of insertion of warm water into the rectum.
|
after 1minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kyu Joo Park, MD, PhD, Department of Surgery, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
April 4, 2010
First Submitted That Met QC Criteria
April 26, 2010
First Posted (Estimate)
April 27, 2010
Study Record Updates
Last Update Posted (Estimate)
April 27, 2010
Last Update Submitted That Met QC Criteria
April 26, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 0620092310
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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