aser therapy for OAB and vaginal atrophy - a randomised intervention study

Phase 4

Recruiting

• Conditions: N39.42; N89.9; Noninflammatory disorder of vagina, unspecified

• Registration Number: DRKS00021473
• Lead Sponsor: St. Josefs Hospital Wiesbaden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Informed consent
- legal age
- normal Pap smear
- symptoms consistent with vaginal atrophy and OAB requiring treatment

Exclusion Criteria

known neurological cause of OAB
- residual urine ( > 150ml)
- urinary tract infection, pregnancy, vaginal infection/wound, menstruation, light-allergy
- current use of vaginal estrogens
- current use of anticholinergic medications or mirabegron
- current use of anticoagulants (except ASS)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main target value is the measurement of urge symptoms, evaluated by the OAB Symptom Score (time difference from baseline). <br>The evaluation of the PPIUS is considered as an important supporting parameter. The primary time is time 2 (3 months after the 2nd treatment).

Secondary Outcome Measures

Name	Time	Method
Reduction of nighttime frequency, reduction of urge incontinence, improvement of symptoms of vaginal atrophy, improvement in quality of life.<br><br>The OAB Symptom Score and the Patients' Perception of Intensity of Urgency Scale (PPIUS) are questionnaires used to assess the symptoms and effects of OAB. The Vaginal Health Index (VHI) score is used to assess vaginal atrophy. The King's Health Questionnaire by Kelleher or Bjelic-Radisic measures the quality of life in women with symptoms of the lower urinary tract. <br><br>The data collection and surveys are conducted at four points in time: On day 0 (baseline before the first laser treatment), after 6-8 weeks (time 1, before the second laser treatment) as well as three months (time 2) and six months (time 3) after completion two treatment sessions. The primary measurement time is time 2 (3 months after the second treatment).