Anorectal PhysiologyEarly Phase 1NCT01111006
The Effect of Electronic Cleansing Toilet System (Bidet) on Anal Resting Pressure
A Early Phase 1 study testing Bidet (electronic cleansing toilet system) in people with Anorectal Physiology, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to evaluate the effect of Bidet on anal resting pressure with regards to various flow rates and temperatures. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorectal Physiology
- What is being tested?
- Bidet (electronic cleansing toilet system)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Jan 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer
Who cannot join
- anal disease pregnancy any medical disease that is necessary to treat psychosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorectal Physiology
- Being tested
- Bidet (electronic cleansing toilet system)
- Keywords
- Electronic toilet, Bidet, Anorectal resting pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bidet (electronic cleansing toilet system)Device
Also called Bidet
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
The pressure before and after applying the bidet
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)
Measured: after 1minute
Secondary outcomes (1)
The temperature of rectum
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.
Measured: after 1minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal PhysiologyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Woongjin Coway Corporation
- Investigators
- Kyu Joo Park, MD, PhD, Principal investigator, Department of Surgery, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111006
- Sponsor's protocol ID
- 0620092310
- Status last verified
- Apr 2010
- First submitted
- 4 Apr 2010
- Last updated
- 27 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electronic Cleansing Toilet System (Bidet) on Anal Resting Pressure in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01111006
- Acronym / sponsor ID
- 0620092310
- Conditions
- Anorectal Physiology
- Keywords
- Electronic toilet, Bidet, Anorectal resting pressure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Woongjin Coway Corporation
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the effect of Bidet on anal resting pressure with regards to various flow rates and temperatures.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteer
Key exclusion criteria (1 listed)
- anal disease pregnancy any medical disease that is necessary to treat psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bidet (electronic cleansing toilet system)Also: BidetThe 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). | Device | – |
Primary outcome
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)
1 secondary outcome
The temperature of rectum
Time frame: after 1minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu Joo Park, MD, PhD principal investigator
Department of Surgery, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bidet (electronic cleansing toilet system) in people with Anorectal Physiology, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pressure before and after applying the bidet (time frame: after 1minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2010.