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The Effect of Electronic Cleansing Toilet System (Bidet) on Anal Resting Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01111006
First Posted: April 27, 2010
Last Update Posted: April 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Woongjin Coway Corporation
Information provided by:
Seoul National University Hospital
  Purpose
The purpose of this study was to evaluate the effect of Bidet on anal resting pressure with regards to various flow rates and temperatures.

Condition Intervention Phase
Anorectal Physiology Device: Bidet (electronic cleansing toilet system) Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Electronic Cleansing Toilet System (Bidet) on Anal Resting Pressure in Normal Healthy Volunteers

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Bidet (electronic cleansing toilet system)
    The volunteers underwent rectal examinations and baseline manometry at lateral decubitus position. Subjects were then placed on a toilet with Bidet attached and manometry catheter was inserted and fixed placing the channels of the catheter at the high pressure zone (HPZ) of the anal canal. Anorectal pressures were measured before and after using the Bidet under different water pressures (4, 8, 16, 20 gram force, gf), types of water stream (narrow vs. wide), and different temperatures (24oC vs. 38oC).
    Other Name: Bidet
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteer

Exclusion Criteria:

  • anal disease pregnancy any medical disease that is necessary to treat psychosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111006


Locations
Korea, Republic of
Department of Surgery, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Woongjin Coway Corporation
Investigators
Principal Investigator: Kyu Joo Park, MD, PhD Department of Surgery, Seoul National University Hospital
  More Information

Responsible Party: Kyu Joo Park, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01111006     History of Changes
Other Study ID Numbers: 0620092310
First Submitted: April 4, 2010
First Posted: April 27, 2010
Last Update Posted: April 27, 2010
Last Verified: April 2010

Keywords provided by Seoul National University Hospital:
Electronic toilet
Bidet
Anorectal resting pressure