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Anal Resting Pressure After Bidet, Compared to Sitz Bath

The Effects of Electronic Bidet on Anal Resting Pressure, Compared to Conventional Sitz Bath in Normal Healthy Volunteers

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02244840
Acronym
Bidet(2)
Enrollment
40
Registered
2014-09-19
Start date
2011-12-31
Completion date
2014-04-30
Last updated
2014-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorectal Disorders

Keywords

Bidet, Sitz bath, Anal resting pressure

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.

Interventions

commercial electronic bidet

DEVICESitz bath

Conventional sitz bath

Sponsors

Coway Research and Development Center
CollaboratorUNKNOWN
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* health volunteers

Exclusion criteria

* anorectal disorder * medical comorbidities * pregnancy * history of vaginal delivery

Design outcomes

Primary

MeasureTime frameDescription
Anal Resting Pressure Change3 minutebefore and after bidet/sitz bath for 3 minute

Secondary

MeasureTime frameDescription
Convenience3 minuteQuestionnaires

Countries

South Korea

Participant flow

Participants by arm

ArmCount
Electronic Bidet and Sitz Bath
Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject Electronic bidet: commercial electronic bidet Sitz bath: Conventional sitz bath
40
Total40

Baseline characteristics

CharacteristicElectronic Bidet and Sitz Bath
Age, Continuous30.0 years
Region of Enrollment
Korea, Republic of
40 participants
Sex: Female, Male
Female
20 Participants
Sex: Female, Male
Male
20 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 40
serious
Total, serious adverse events
0 / 40

Outcome results

Primary

Anal Resting Pressure Change

before and after bidet/sitz bath for 3 minute

Time frame: 3 minute

ArmMeasureGroupValue (MEAN)Dispersion
Electronic Bidet and Sitz BathAnal Resting Pressure ChangeBaseline Electronic bidet90.2 mmHgStandard Deviation 24.6
Electronic Bidet and Sitz BathAnal Resting Pressure ChangePost Electronic Bidet71.3 mmHgStandard Deviation 23.4
Electronic Bidet and Sitz BathAnal Resting Pressure ChangeBaseline Sitz bath88.1 mmHgStandard Deviation 16.8
Electronic Bidet and Sitz BathAnal Resting Pressure ChangePost Sitz Bathbath69.6 mmHgStandard Deviation 19.8
Secondary

Convenience

Questionnaires

Time frame: 3 minute

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026