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Comparing pain during pessary change: sitting position versus side-lying position

A randomized trial comparing pain levels during pessary replacement in lithotomy versus left-lateral position among women with pelvic organ prolapse

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16907860
Enrollment
128
Registered
2026-04-20
Start date
2026-04-16
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Pain and procedural comfort during pessary replacement in women with pelvic organ prolapse. Urological and Genital Diseases

Interventions

This study is a randomized, parallel-group controlled trial comparing two active interventions: lithotomy position (control) and left-lateral position (intervention) during routine pessary removal and

Sponsors

University of Malaya
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18 years and above 2. Diagnosed with pelvic organ prolapse (POP) 3. Currently using a ring pessary for management of POP 4. Scheduled for routine pessary removal and replacement at the gynaecology clinic 5. Able to lie in both lithotomy and left-lateral positions safely 6. Able to understand the study information and provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Women undergoing first-time pessary insertion 2. Presence of active vaginal infection (e.g. vaginitis, ulceration requiring treatment) 3. History of postmenopausal bleeding within the past 6 months 4. Inability to safely tolerate lithotomy or left-lateral position (e.g. severe hip or knee osteoarthritis, recent lower limb or pelvic surgery, significant spinal deformity, severe chronic back pain, or marked mobility limitation) 5. Acute vaginal complications requiring urgent management (e.g. significant bleeding, severe pain, or suspected injury) 6. Cognitive impairment or language barrier preventing understanding of the study or reliable pain scoring 7. Declines or unable to provide informed consent

Countries

Malaysia

Contacts

Public ContactAdli Hakimi;Mukhri Zulkifli;Hamdan

;

adlihakimi888@ummc.edu.my;mukhri@ummc.edu.my+601110568087;+60123615253

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026