A randomized trial comparing pain levels during pessary replacement in lithotomy versus left-lateral position among women with pelvic organ prolapse
Pain and procedural comfort during pessary replacement in women with pelvic organ prolapse.
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 replacement in women with pelvic organ prolapse. Eligible participants will be identified during scheduled gynaecology clinic visits and recruited following informed consent. Participants will be randomly assigned in a 1:1 ratio to either lithotomy or left-lateral position using a sealed opaque envelope method to ensure allocation concealment. All procedures will be performed by trained obstetrics and gynaecology clinicians following a standardized technique for pessary removal and reinsertion using the participant’s usual ring pessary and appropriate lubrication. The intervention consists of positioning the participant either in the lithotomy or left-lateral position during the procedure. No change in pessary type or size will be made. The primary outcome is patient-reported pain measured using a 0–10 Numerical Rating Scale (NRS) immediately after pessary removal and at 5 minutes post-procedure. Secondary outcomes include patient-reported comfort, acceptability and dignity, clinician-reported ease of insertion, procedure duration, need for repositioning or rescue measures, and occurrence of adverse events such as vaginal trauma or bleeding. Participants will remain in their assigned position throughout the procedure unless a rescue change of position is required for safety, excessive discomfort, or procedural difficulty. All analyses will be conducted according to the initial randomized allocation.
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
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