Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00093

2 Trial Registration Date

2005-12-15

i Registration Status

Retrospective

3 Secondary IDs

N.A.

4 Source(s) of Funding

Department of Obstetrics & Gynaecology

5 Primary Sponsor

N.A.

6 Secondary Sponsor

N.A.

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Prof. Yip Shing-Kai

ii Address

iii Phone

iv Email

Email yipsk@cuhk.edu.hk

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Yip Shing-Kai

ii Address

iii Phone

iv Email

Email yipsk@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

A Randomised Double-blind Placebo-controlled Trial of Prophylactic Antibiotics in Preventing Female Urinary Tract Infection After Urodynamic Study

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N.A.

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-03-02

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Urinary Tract Infection

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Augmentin 375mg (single oral dose)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

15 min

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo 1 tab

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: All women requiring urodynamic studies attending the Urodynamic Clinic at Prince of Wales Hospital will be explained about the study and will be recruited.

ii Exclusion Criteria

Exclusion criteria: Excluded from the study with either one of the following criteria: (1) evidence of UTI at the time of UDS, (2) receiving antibiotics treatment, (3) had received antibiotics treatments two weeks before UDS, (4) requiring prophylactic antibiotics for invasive procedures, (5) allergic to antibiotics, (6) possible drug-drug interaction, and (7) refusal to participate.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-10-17

21 Target Sample Size

200/200

22 Recruitment Status

Complete

23 Primary Outcome

This project will answer the clinical question of whether prophylactic antibiotic is useful in preventing UTI in women undergoing UDS. This will change the clinical practice in managing such patients in Hong Kong, whom at the present moment have high prevalence of post-UDS UTI.

24 Secondary Outcome

N.A.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2006-10-14

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N.A.

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Trial History Detail on 2009-11-19