Overactive bladder Menopausal women Urinary incontinence Vaginal radiofrequency Monopolar radiofrequency Overactive bladder Energy based devices
Conditions
Interventions
Vaginal resistive monopolar radiofrequency probe operating
at 448 kHz (INDIBA, Spain) Setting recommended by the company
10% power intensity, 20 minutes each session weekly 6 consecutive weeks,The p
Vaginal Radiofrequency ,Sham
Sponsors
Chulalongkorn University
Eligibility
Sex/Gender
Female
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Thai postmenopausal women age at least 40 years or older who experienced a menopause (amenorrhea for 12 months or more) 2. Diagnosed with Idiopathic OABS, defined by OABSS (Urgency score for 2 or more, and Total OABSS for 3 or more) 3. Unable or unwilling to use other treatment options
Exclusion criteria
Exclusion criteria: 1.History of any treatment for OABs or medication within the past 3 months or current use medications 2.History of hormonal therapy within the past 6 months or currently used 3. History of stress urinary incontinence (SUI) or mixed urinary incontinence 4. Postvoid residual urine more than 200 ml 5.Polydipsia: total fluid intake more than three liters daily 6. Poor controlled DM 7. Pelvic organ prolapse quantification (POP-Q) stage 2 or more 8. Presence of neurogenic disease: Stroke, Parkinson, Spinal cord injury 9. Patient with indwelling catheters or practicing intermittent self-catheterization 10.Presence of Acute/recurrent urinary tract infection or active genital infection, such as Abscess or Herpes zoster 11. Chronic inflammation of lower urinary tract e.g. interstitial cystitis, bladder stone 12. Contagious genital infection including Condyloma, HIV infection 13.Use Intrauterine Device (IUD) 14 Presence of pacemakers or other electronic implants 15 Abnormal cervical cytology, vulvar lesions, vaginal lesions 16 History of deep venous thrombosis or emboli (VTE) 17 Recent pelvic surgery within 12 months 18 History of genital surgery with mesh includes transvaginal mesh or mid-urethral sling or bladder surgery 19 Prior pelvic irradiation 20. Unexplained Abnormal vaginal bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overactive bladder symptoms score (OABSS) at 4 weeks after interventions Overactive bladder symptoms score, mean difference of score change between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Overactive Bladder Questionnaire Shortform (OAB-q SF) at 4 weeks after interventions Overactive Bladder Questionnaire Shortform mean score change between groups and within the same group (pre-post test comparison),Patient Perception of Bladder Condition score (PPBC score) at 4 weeks after interventions Patient Perception of Bladder Condition score change between groups and within the same group (pre-post test comparison),Bladder diary at 4 weeks after interventions Record of intake and voiding volume-time in 24 hours for three days compare pre-post treatment ,Participant satisfaction at 4 weeks after interventions Visual analog scale ,Adverse events at 4 weeks after interventions Open ended questions | — |
Countries
Thailand
Contacts
Public ContactApisit Rungruengsirichok
Chulalongkorn University
Outcome results
None listed