Anal Resting Pressure After Bidet, Compared to Sitz Bath (Bidet(2))
Primary Purpose
Anorectal Disorders
Status
Completed
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electronic bidet
Sitz bath
Sponsored by
About this trial
This is an interventional treatment trial for Anorectal Disorders focused on measuring Bidet, Sitz bath, Anal resting pressure
Eligibility Criteria
Inclusion Criteria:
- health volunteers
Exclusion Criteria:
- anorectal disorder
- medical comorbidities
- pregnancy
- history of vaginal delivery
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electronic bidet and sitz bath
Arm Description
Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject
Outcomes
Primary Outcome Measures
Anal Resting Pressure Change
before and after bidet/sitz bath for 3 minute
Secondary Outcome Measures
Convenience
Questionnaires
Full Information
NCT ID
NCT02244840
First Posted
September 16, 2014
Last Updated
September 26, 2014
Sponsor
Seoul National University Hospital
Collaborators
Coway Research and Development Center
1. Study Identification
Unique Protocol Identification Number
NCT02244840
Brief Title
Anal Resting Pressure After Bidet, Compared to Sitz Bath
Acronym
Bidet(2)
Official Title
The Effects of Electronic Bidet on Anal Resting Pressure, Compared to Conventional Sitz Bath in Normal Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Coway Research and Development Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Sitz bath is conventional and empirical remedy and commonly recommended for non-operative treatment of various anal diseases. However, as there was no substitute for sitz bath until now, the patients have to accept the inconvenience for treatment of their diseases.
Electronic bidet is used with convenience as automatic device for cleansing the perineal area, especially after defecation. The similarity of contacting water to perineal area, clinical use of electronic bidet has been suggested for treatment of anal diseases. However, there had been few reports of clinical use of electronic bidet.
Investigators performed the study to evaluate the effects of electronic bidet on anal resting pressure, compared to conventional warm sitz bath in normal healthy volunteers.
Detailed Description
Baseline Anorectal Manometry
The Subjects underwent a digital rectal examination and baseline anorectal manometry in the lateral decubitus position using a device from Dynacompact (Menfis Biomedica Corp., Bologna, Italy) using an 8 channel polyvinyl (PVC) catheter with the measuring orifices oriented radially. Resting and maximal pressure in the anal canal were measured by pulling the catheter out of the anorectum at a speed of 0.5 mm/sec (the 'rapid pull through' technique)
Recordings of Anal Resting Pressure on Electronic Bidet and Sitz Bath
The subjects underwent clinical experiments for recordings of anal resting pressure changes using the electronic bidet and taking the sitz bath. For the measurement of effects of electronic bidet on anal resting pressure, a different manometry catheter (8 spirally arranged channels, 0.5 cm apart) was inserted into the anal canal placing the upper channels (channels No. 1-2) with a temperature probe in the rectum and the lower channels (channel No. 3-8) in the anal canal. The catheter was fixed in the buttock area using waterproof tape and subjects sat on a toilet equipped with an electronic bidet (Coway Corp, Seoul, Korea). After anal resting pressure had stabilized at the sitting position, anal resting pressure at high pressure zone (HPZ) was checked as control value to measure the change of anal resting pressure. The anal high pressure zone (HPZ) was defined as the channel representing the highest pressure within the anal canal for each subject. The pressures while sitting were adjusted for gravity. A water flow of the electronic bidet was applied to the anus for 3 minute. We designed the new water flow system of the electronic bidet, which was fountain type with very low force (10mN), as water falls down immediately after contacting the perineal area (Fig 1A). Before applying the water flow, mist type of water particles was sprayed for a few seconds for gentle contact with water first. The water used in the electronic bidet was a tap water of warm temperature about 38 degree celsius. Anal resting pressure at the channel of HPZ was checked at 1, 2 and 3 minutes after using the electronic bidet and percentage of anal resting pressure was calculated with compared to control value checked before using the electronic bidet. Maximum and minimum pressures in the HPZ during application of the electronic bidet were noted.
Sitz bath was also undergone at another day. After insertion of catheter, the subjects were seated on a chair with small tub filled with warm water of about 38 degree celsius and sink their buttock (Fig 1B). The measurements of anal resting pressure were similar to the electronic bidet. Anal resting pressures of HPZ were checked before and after using the electronic bidet for 3 minutes. Maximum and minimum pressures were also checked.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorectal Disorders
Keywords
Bidet, Sitz bath, Anal resting pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electronic bidet and sitz bath
Arm Type
Experimental
Arm Description
Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject
Intervention Type
Device
Intervention Name(s)
Electronic bidet
Intervention Description
commercial electronic bidet
Intervention Type
Device
Intervention Name(s)
Sitz bath
Intervention Description
Conventional sitz bath
Primary Outcome Measure Information:
Title
Anal Resting Pressure Change
Description
before and after bidet/sitz bath for 3 minute
Time Frame
3 minute
Secondary Outcome Measure Information:
Title
Convenience
Description
Questionnaires
Time Frame
3 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
health volunteers
Exclusion Criteria:
anorectal disorder
medical comorbidities
pregnancy
history of vaginal delivery
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongro-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
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Anal Resting Pressure After Bidet, Compared to Sitz Bath
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