Treatment of patients with pelvic organ prolapse using vaginal ring pessary Urological and Genital Diseases
Conditions
Interventions
Recruitment
Patient recruitment will take place in the Gynaecology Clinic of Universiti Malaya Medical Centre (UMMC). The Eligibility Assessment Form containing study inclusion and exclusion criteria
Sponsors
Early Career Research Grant (ECRG) Bahagian Pengurusan Geran Penyelidikan
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Symptomatic stage 1 to Stage 4 POP (using the POP-Q system assessment) 2. Shared decision for a vaginal ring pessary to treat POP 3. Never before used a vaginal pessary for POP treatment
Exclusion criteria
Exclusion criteria: 1. Existing vaginal or vulvar lacerations / ulcers 2. Vaginal infection 3. Previous vaginal repair surgery (not including childbirth-related perineal repair) 4. Postmenopausal bleeding in the last 6 months (if not fully investigated) 5. Abnormal cervical screening (if not fully investigated)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Participants’ satisfaction with the pessary fitting process (after successful fitting, at end of clinic visit), using an 11-point 0-10 Numeric Rating Scale (NRS) [higher score, greater satisfaction] (by participants) 2. Participants’ satisfaction with pessary use, using an 11-point 0-10 NRS [higher score, greater satisfaction] (at three months follow up) (by participants) | — |
Secondary
| Measure | Time frame |
|---|---|
| At the end of clinic visit, record 1. Successful fitting (by provider) 2. Make of successfully-fitted pessary (by provider) 3. Participants’ pain score associated with insertion using an 11-point 0-10 NRS [higher score, greater pain] (by participants) 4. Number of fitting attempts (until successful fitting) (by provider) 5. Ease of insertion using an 11-point 0-10 NRS [higher score, greater ease] (by provider) 6. Ring diameter of successfully-fitted pessary (by provider) At three months follow up, record 7. Pessary discontinuation and reason (by participants) 8. Pessary make in use (by provider) 9. Adverse interim symptoms during first three months after pessary insertion using a 4-grade Likert scale (by participants): 9.1. Bothersome vaginal discharge 9.2. Vulva-vaginal itching 9.3. Vaginal bleeding 9.4. Pessary dislodged 9.5. I can feel the pessary 9.6. Pessary discomfort 10. Number of unscheduled pessary-related visits (by participants) 11. Prolapse Quality of Life (P-QOL) questionnaire (by participants) 12. Recommends allocated (PVC or silicone) ring pessary to a friend, using a 5-grade Likert scale (by participants) 13. Pessary removal 13.1. Participants’ pain score associated with removal using 0–10 NRS [higher score, greater pain] (by participants) 13.2. Ease of removal using 0–10 NRS [higher score, greater ease] (by provider) 13.3. Pessary condition: Reusable / Needs replacement (by provider) 14. Vulval and vaginal (speculum) examination after pessary removal (by provider) 14.1. Vaginal mucosal erosion / ulceration 14.2. Vaginal mucopurulent discharge 14.3. Vaginal foul / offensive odour 15. Major harms, if present (by provider) 15.1. Pessary retention requiring surgical release under anaesthesia 15.2. Lower genital laceration requiring surgical repair under anaesthesia 16. Stage of Pelvic Organ Prolapse using POP-Q (Pelvic Organ Prolapse Quantification) system (by provider) 17. Pessary insertio | — |
Countries
Malaysia
Contacts
Public ContactAtiqa;Farah Abu Bakar;Mohd Faiz Gan
;
Outcome results
None listed