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Vaginal pessary in the management of pelvic organ prolapse with stress urinary incontinence: a randomized controlled trial

Vaginal pessary in the management of pelvic organ prolapse with stress urinary incontinence: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034613
Enrollment
Unknown
Registered
2020-07-12
Start date
2020-07-20
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

pelvic organ prolapse with stress urinary incontinence

Interventions

Group 1:vaginal ring pessaries
Group 2:ring pessary with knob group (continence pessary)

Sponsors

None listed

Eligibility

Sex/Gender
Male
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 or above; 2. Patients with pelvic organ prolapse according to Pelvic Organ Prolapse Quantification (POP-Q) assessment, and with stress urinary incontinence symptoms; 3. Patients who are willing to give written consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who had history of continence operations; 2. Patients who have conditions contraindicated to use vaginal pessary, such as silicone allergy and presence of vaginal ulcers; 3. Patients unwilling to try pessary treatment; 4. Patients who are planning for pregnancy, or mental incapacity; 5. Patients who cannot understand written Chinese; 6. Patients refuse to participate in the study.

Design outcomes

Primary

MeasureTime frame
Reduction in the PFDI Urinary Distress Inventory scores between both groups at 6 months and 12 months after treatment;

Secondary

MeasureTime frame
1. Improvements of stress urinary incontinence using the Visual Analog Scale;2. Patients’ satisfaction on the vaginal pessaries using the Visual Analog Scale;3. Reduction in PFIQ Urinary Impact Questionnaire Domain scores between both groups;4. Changes in other domains of PFDI and PFIQ;5. Complications arising from vaginal pessaries;

Countries

China

Contacts

Public ContactLee Yung Ting

Department of Obstetrics and Gynaecology, Princess Margaret Hospital

lyt271@ha.org.hk+852 29901111

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026