Anal Resting Pressure After Bidet, Compared to Sitz Bath

Anorectal Disorders Clinical Trial

— Bidet(2)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244840
• Other study ID #: 0620113700
• Status: Completed
• Phase: Phase 0
• First received: September 16, 2014
• Last updated: September 26, 2014
• Start date: December 2011
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• health volunteers

Exclusion Criteria:

• anorectal disorder

• medical comorbidities

• pregnancy

• history of vaginal delivery

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorectal Disorders

Intervention

Device:
• Electronic bidet
commercial electronic bidet
• Sitz bath
Conventional sitz bath

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongro-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Coway Research and Development Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal Resting Pressure Change	before and after bidet/sitz bath for 3 minute	3 minute	No
Secondary	Convenience	Questionnaires	3 minute	No