Postmenopausal women who complain of urgency and frequency of urination Overactive bladder OAB Menopause Postmenopause Vaginal atrophy Er:YAG Vaginal laser treatment Treatment Bladder diary Micturition diary Quality of life
Conditions
Interventions
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The participant will be in lithotomy position then the investigator will insert the vaginal probe in the vaginal canal.
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This procedure does not require anesthesia.
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Participant will receive one session of vaginal laser treatment. ,-
Participant will receive the same procedure as intervention group but the laser will not be emitted.
Experimental Device,Sham Comparator Device
Erbium: Yttrium-
Aluminum-
Garnet (Er: YAG) vaginal laser treatment (MCL31 Dermablate,
Asclepion Laser),Sham procedure
Sponsors
Ratchadapiseksompotch Fund
Eligibility
Sex/Gender
Female
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women 2. Age > 55 years 3. Parous women 4. Complain one or more VVA symptom such as the symptom of vaginal dryness, vaginal irritation, soreness or dyspareunia 5. Diagnosis of overactive bladder syndrome by - Participant had complained of frequency of urination and urgency with or without urge incontinence for more than three months 6. 3-day bladder diary at baseline showed twenty-four-hour frequency ≥ 8 times with at least three episodes of urgency with or without incontinence 7. Participant has not received OAB treatment or hormonal treatment for vulvovaginal atrophy.
Exclusion criteria
Exclusion criteria: 1. Stress or mixed urinary incontinence 2. Pelvic organ prolapse in any compartment higher than stage I (Pelvic Organ Prolapse Quantification System) 3. Symptomatic urinary tract infection diagnosis by urinalysis 4. History of interstitial cystitis, bladder stone or diabetic neuropathy 5. Post-void residual urine volume >200 ml diagnosis by bladder scan 6. Previous pelvic radiation therapy 7. Previous or current malignant disease of the pelvic organs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patient-reported symptom severity 3 months Overactive Bladder Symptom Score (OABSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life 3 months Overactive bladder questionnaire (OAB-q) /Patient Perception of Bladder Condition Questionnaires (PP,24-hour frequency and urgency episodes 3 months Bladder diary,Vuvovaginal atrophy symptom and vaginal health index score 3 months Vuvovaginal atrophy symptom /vaginal health index score | — |
Countries
Thailand
Contacts
Public ContactKeerati Chiengthong
Faculty of medicine,King chulalongkorn memorial hospital
Outcome results
None listed