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Anal Resting Pressure After Bidet, Compared to Sitz Bath (Bidet(2))

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ClinicalTrials.gov Identifier: NCT02244840
Recruitment Status : Completed
First Posted : September 19, 2014
Results First Posted : October 3, 2014
Last Update Posted : October 3, 2014
Sponsor:
Collaborator:
Coway Research and Development Center
Information provided by (Responsible Party):
Kyu Joo Park, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Anorectal Disorders Device: Electronic bidet Device: Sitz bath Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Electronic Bidet on Anal Resting Pressure, Compared to Conventional Sitz Bath in Normal Healthy Volunteers
Study Start Date : December 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Electronic bidet and sitz bath
Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject
Device: Electronic bidet
commercial electronic bidet

Device: Sitz bath
Conventional sitz bath




Primary Outcome Measures :
  1. Anal Resting Pressure Change [ Time Frame: 3 minute ]
    before and after bidet/sitz bath for 3 minute


Secondary Outcome Measures :
  1. Convenience [ Time Frame: 3 minute ]
    Questionnaires



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • health volunteers

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244840


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Jongro-gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Coway Research and Development Center
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Responsible Party: Kyu Joo Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02244840    
Other Study ID Numbers: 0620113700
First Posted: September 19, 2014    Key Record Dates
Results First Posted: October 3, 2014
Last Update Posted: October 3, 2014
Last Verified: September 2014
Keywords provided by Kyu Joo Park, Seoul National University Hospital:
Bidet, Sitz bath, Anal resting pressure
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases