Anorectal Disorders Clinical Trial
Official title:
The Effects of Electronic Bidet on Anal Resting Pressure, Compared to Conventional Sitz Bath in Normal Healthy Volunteers
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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