NCT01111006

Brief Summary

The purpose of this study was to evaluate the effect of Bidet on anal resting pressure with regards to various flow rates and temperatures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2009

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

Enrollment Period

4 months

First QC Date

April 4, 2010

Last Update Submit

April 26, 2010

Conditions

Anorectal Physiology

Keywords

Electronic toiletBidetAnorectal resting pressure

Outcome Measures

Primary Outcomes (1)

  • The pressure before and after applying the bidet

    After the anal resting pressure was stabilized at sitting position, water stream of the bidet was applied to anus for 1 minute under various settings of different pressures (4, 8, 16, 20 gram force, gf), temperatures (24oC vs. 38oC), types of stream (narrow vs. wide) (Total time for experiment at individual subject was about two hours)

    after 1minute

Secondary Outcomes (1)

  • The temperature of rectum

    after 1minute

Interventions

Bidet (electronic cleansing toilet system)DEVICE

The volunteers underwent rectal examinations and baseline manometry at lateral decubitus position. Subjects were then placed on a toilet with Bidet attached and manometry catheter was inserted and fixed placing the channels of the catheter at the high pressure zone (HPZ) of the anal canal. Anorectal pressures were measured before and after using the Bidet under different water pressures (4, 8, 16, 20 gram force, gf), types of water stream (narrow vs. wide), and different temperatures (24oC vs. 38oC).

Also known as: Bidet

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteer

You may not qualify if:

  • anal disease pregnancy any medical disease that is necessary to treat psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Study Officials

  • Kyu Joo Park, MD, PhD

    Department of Surgery, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2010

First Posted

April 27, 2010

Study Start

September 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 27, 2010

Record last verified: 2010-04

Locations

KR(1)