Efficacy of Erbium YAG laser treatment in Overactive bladder syndrome: a randomized controlled trial

Not Applicable

• Conditions: 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

• Registration Number: TCTR20181218002
• Lead Sponsor: Ratchadapiseksompotch Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-18
• Study Completion: 2020-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 118

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The patient-reported symptom severity 3 months Overactive Bladder Symptom Score (OABSS)

Secondary Outcome Measures

Name	Time	Method
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