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Trial History Detail on 2017-10-03

CUHK_CCRB00515

2016-06-03

Prospective

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

Hospital Authority Clinical Research Centre Mini Research Grant

Department of Obstetrics and Gynaecology, Princess Margaret Hospital

N/A

Not Applicable

Man Sum Tam

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

90783324/64610293

gmstam@gmail.com

Department of Obstetrics and Gynaecology, Princess Margaret Hospital

Hong Kong

Man Sum Tam

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

90783324

gmstam@gmail.com

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

Hong Kong

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

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

盆腔器官脫垂更換陰道托環時間的研究

Hong Kong

Yes

2016-03-21

Kowloon West Cluster Research Ethics Committee

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

Pelvic organ prolapse

Device

Polyvinyl chloride vaginal ring pessary, brand name "Portia"

Vaginal ring pessary

one vaginal ring pessary

6 months

change every 3 months or 6 months

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.

Vaginal ring pessary

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

6 moths

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

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.

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

18

100

Female

Interventional

Randomized

Randomized controlled trial

Active

Single-blind

Trial subjects

Parallel

0

2016-06-08

60

Complete

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

Clinical assessment. Visual analog scale.

6 months

Effect on degree of prolapse staging on clinical examination.

Clinical examination

6 months

No

2018-10-23

ChiCTR-IOR-16008597

2016-06-03

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