Pelvic organ prolapse managed by ring pessary Urological and Genital Diseases
Conditions
Interventions
Patients attending to Gynaecology Clinic University Malaya Medical Centre (UMMC) for ring pessary change will be screened for study eligibility. The eligibility assessment form (EAF) will be used for
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Attending clinic for ring pessary follow-up 2. PVC ring pessary in situ 3. Intends to continue using the ring pessary
Exclusion criteria
Exclusion criteria: 1. Postmenopausal bleeding in the last 6 months (if not investigated) 2. Abnormal cervical cytology/histology (if not investigated) 3. Previous participation in the trial 4. Allergy history to lidocaine or prilocaine 5. Has underlying medical condition not suitable for local lidocaine or prilocaine application such as porphyria, G6PD deficiency and methemoglobinemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pessary removal pain score using an 11-point 0-10 numerical rating scale (NRS) [0: No pain, 10: Worst pain imaginable] immediately after removal of ring pessary 2. Patient satisfaction with the ring pessary change assessed using an 11-point 0-10 numerical rating scale (NRS) [0: fully dissatisfied, 10: fully satisfied] after successful ring pessary re-insertion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensation felt in the area of cream application (i.e., vagina) assessed 2 minutes after application of allocated study cream: a. Tingling: Yes/No b. Stinging: Yes/No c. Burning: Yes/No d. Itching: Yes/No 2. Speculum vaginal examination pain score assessed using an 11-point 0-10 numerical rating scale (NRS) [higher score, greater pain] immediately after speculum examination 3. Pessary reinsertion pain score assessed using an 11-point 0-10 numerical rating scale (NRS) [higher score, greater pain] immediately after ring pessary re-insertion 4. Recommend the local application of allocated cream for pessary change to a friend, assessed using a 5-point Likert scale [Strongly Agree, Agree, Neutral, Disagree, Highly Disagree response options] before clinic discharge 5. Sensation felt in the area of cream application (i.e., vagina) assessed before clinic discharge: a. Tingling: Yes/No b. Stinging: Yes/No c. Burning: Yes/No d. Itching: Yes/No | — |
Countries
Malaysia
Contacts
Public ContactNoor Saswani;Tan Binti Saseli;Peng Chiong
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Outcome results
None listed