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Trial History Detail on 2015-02-03

CUHK_CCT00302

2011-11-15

Prospective

nil

Obstetrics and Gynaecology Department, the Chinese University of Hong Kong

nil

nil

Lee Ho Sze Jacqueline

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

26326250

jaclee@cuhk.edu.hk

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

Lee Ho Sze Jacqueline

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

26326250

jaclee@cuhk.edu.hk

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

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

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

A RCT on management of pelvic organ prolapse

Hong Kong

Yes

2011-10-18

Pelvic organ prolapse

Device

Vaginal ring pessary

1 year

Conservative treatment without ring pessary

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

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

nil

nil

Female

Interventional

Randomized

Not Applicable

Single-blind

Parallel

2011-12-01

240

Complete

The efficacy of symptoms improvement based on PFDI and PFIQ assessment

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

No

2015-02-03

ChiCTR-TRC-11001796

2011-12-14


Yes

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