Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00302

2 Trial Registration Date

2011-11-15

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

Obstetrics and Gynaecology Department, the Chinese University of Hong Kong

5 Primary Sponsor

nil

6 Secondary Sponsor

nil

Function

Please specify

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

i Name

Lee Ho Sze Jacqueline

ii Address

Department of Obstetrics & Gynaecology Prince of Wales Hospital 30-32 Ngan Shing Street Shatin, New Territories Hong Kong

iii Phone

26326250

iv Email

jaclee@cuhk.edu.hk

v Affiliation

Department of Obstetrics & Gynaecology, the Chinese University of Hong Kong

vi Country

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

i Name

Lee Ho Sze Jacqueline

ii Address

Department of Obstetrics & Gynaecology Prince of Wales Hospital 30-32 Ngan Shing Street Shatin, New Territories Hong Kong

iii Phone

26326250

iv Email

jaclee@cuhk.edu.hk

v Affiliation

Department of Obstetrics & Gynaecology, the Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

randomised controlled trial of vaginal ring pessary versus conservative management in women with pelvic organ prolapse

10 Public Title

randomised controlled trial of vaginal ring pessary versus conservative management in women with pelvic organ prolapse

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

A RCT on management of pelvic organ prolapse

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-10-18

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Pelvic organ prolapse

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Vaginal ring pessary

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 year

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Conservative treatment without ring pessary

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

1. Patients with stage I to III pelvic organ prolapse according to Pelvic Organ Prolapse Quantification (POP-Q) assessment who have not received treatment before the consultation
2. Willing to give written consent to participate in the study

ii Exclusion Criteria

1. Patients with stage I to III pelvic organ prolapse but with complications of POP, e.g. confirmed retention of urine or presence of vaginal ulcer at consultation in which they need treatment
2. Patients with stage IV POP who needs intervention to treat their condition or to prevent complications of POP
3. Refused to participate in the study

iii Age Minimum

nil

iv Age Maximum

nil

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Single-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

2011-12-01

21 Target Sample Size

240

22 Recruitment Status

Recruiting

23 Primary Outcome

The efficacy of symptoms improvement based on PFDI and PFIQ assessment

24 Secondary Outcome

1. The rate of successfully fitted vaginal pessary in POP women, the continuation rate of vaginal pessary, and the complication rate of vaginal pessary at one year
2. The factors (including womens’ characteristics, POP-Q findings and Perineal USG parameters) affecting the rate of successful vaginal pessary insertion and continuation of vaginal pessary at one year
3. The decision on treatment option, conservative, vaginal pessary or surgery, for POP at one year

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-02-03

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001796

28 Date of Registration in Primary Registry

2011-12-14

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

nil

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Trial History Detail on 2012-10-18