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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001796
Enrollment
Unknown
Registered
2011-12-14
Start date
2011-12-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse

Interventions

Two groups:Vaginal ring pessary for 1 year versus Conservative treatment without ring pessary

Sponsors

The Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The efficacy of symptoms improvement based on PFDI and PFIQ assessment;

Secondary

MeasureTime frame
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.;

Countries

China

Contacts

Public ContactLee Ho Sze Jacqueline
jaclee@cuhk.edu.hk+852 26326250

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 1, 2026