Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00515

2 Trial Registration Date

2016-06-03

i Registration Status

Prospective

3 Secondary IDs

KW/FR-16-033(96-15)

4 Source(s) of Funding

Hospital Authority Clinical Research Centre Mini Research Grant

5 Primary Sponsor

Department of Obstetrics and Gynaecology, Princess Margaret Hospital

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Man Sum Tam

ii Address

Department of Obstetrics and Gynaecology, Princess Margaret Hospital, 2-10 Princess Margaret Hospital Road, New Territories, Hong Kong

iii Phone

90783324/64610293

iv Email

gmstam@gmail.com

v Affiliation

Department of Obstetrics and Gynaecology, Princess Margaret Hospital

vi Country

Hong Kong

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

i Name

Man Sum Tam

ii Address

Department of Obstetrics and Gynaecology, Princess Margaret Hospital, 2-10 Princess Margaret Hospital Road, New Territories, Hong Kong

iii Phone

90783324

iv Email

gmstam@gmail.com

v Affiliation

Department of Obstetrics and Gynaecology, Princess Margaret Hospital, Princess Margaret Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

Randomised controlled trial on time interval of replacement of vaginal ring pessary for pelvic organ prolapse: a pilot study on the effects of complications and patient’s satisfaction

10 Public Title

Randomised controlled trial on time interval of replacement of vaginal ring pessary for pelvic organ prolapse: a pilot study on the effects of complications and patient’s satisfaction

i Public Title in Chinese 研究名稱

盆腔器官脫垂更換陰道托環時間的研究

11 Short Title (Optional)

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?

2016-03-21

iii Full Name of IRB/IEC

Kowloon West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

KW/FR-16-033(96-15)

14 Medical Condition Being Studied

Pelvic organ prolapse

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Polyvinyl chloride vaginal ring pessary, brand name "Portia"

iii Dosage form of the intervention

Vaginal ring pessary

iv Dosage of the intervention

one vaginal ring pessary

v Duration of the intervention

6 months

vi Frequency of the intervention

change every 3 months or 6 months

16 Comparative Treatments

i Description/ name of comparative treatments

Time interval of ring pessary replacement every 3 months is compared with time interval of every 6 months. Follow-up duration of the study is 6 months.

The incidence of mild, moderate and serious complications will be compared between two groups. Patient's satisfaction will be assessed and compared between two groups.

ii Dosage form of the comparative treatments

Vaginal ring pessary

iii Dosage of the comparative treatments

Time interval of ring pessary replacement every 3 months is compared with time interval of every 6 months.

iv Duration of the comparative treatments

6 moths

v Frequency of the comparative treatments

Time interval of ring pessary replacement every 3 months is compared with time interval of every 6 m

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients on PVC ring pessary for treatment of pelvic organ prolapse for 6 months or more.

Patients aged 18 years or older.

Patients who opted for the use of vaginal pessaries while waiting for surgery.

Pelvic organ prolapse with Pelvic Organ Prolapse Quantification System (POP-Q) stage I to IV.

ii Exclusion Criteria

Serious complications due to use of vaginal pessary that needs discontinuation of use

Patient who cannot come back for shorter follow-up interval (the usual follow-up interval was 6 months)

Patients with ring pessary use less than 6 months

Patients unwilling to continue ring pessary treatment

Patients who cannot understand the study purpose and procedure.

Patients who cannot read the words written in Chinese or English

iii Age Minimum

18

iv Age Maximum

100

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomized controlled trial

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-06-08

21 Target Sample Size

60

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

Complications arise from the use of vaginal pessary. Patient satisfaction on use of vaginal pessary using visual analog score.

ii The metric or method of measurement used

Clinical assessment. Visual analog scale.

iii The timepoint(s) of primary interest

6 months

24 Secondary Outcome

i The Name of the outcome

Effect on degree of prolapse staging on clinical examination.

ii The metric or method of measurement used

Clinical examination

iii The timepoint(s) of primary interest

6 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-10-23

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-16008597

28 Date of Registration in Primary Registry

2016-06-03

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Trial History Detail on 2017-10-03