Anal Resting Pressure After Bidet, Compared to Sitz Bath
Bidet(2)
The Effects of Electronic Bidet on Anal Resting Pressure, Compared to Conventional Sitz Bath in Normal Healthy Volunteers
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Dec 2011
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
September 19, 2014
CompletedResults Posted
Study results publicly available
October 3, 2014
CompletedOctober 3, 2014
September 1, 2014
2.3 years
September 16, 2014
September 20, 2014
September 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anal Resting Pressure Change
before and after bidet/sitz bath for 3 minute
3 minute
Secondary Outcomes (1)
Convenience
3 minute
Study Arms (1)
Electronic bidet and sitz bath
EXPERIMENTALElectronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject
Interventions
Eligibility Criteria
You may qualify if:
- health volunteers
You may not qualify if:
- anorectal disorder
- medical comorbidities
- pregnancy
- history of vaginal delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Jongro-gu, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor
- Organization
- Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 16, 2014
First Posted
September 19, 2014
Study Start
December 1, 2011
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
October 3, 2014
Results First Posted
October 3, 2014
Record last verified: 2014-09