Early Phase 1
N=40
Anal Resting Pressure After Bidet, Compared to Sitz Bath
Anorectal Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02244840 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Anal Resting Pressure Change — 90.2; 71.3; 88.1; 69.6 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Electronic bidet (Device); Sitz bath (Device)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anal Resting Pressure Change |
90.2; 71.3; 88.1; 69.6 | — |
| SECONDARY Convenience |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- health volunteers
Exclusion Criteria
- anorectal disorder
- medical comorbidities
- pregnancy
- history of vaginal delivery
Data sourced from ClinicalTrials.gov (NCT02244840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.