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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021473

Enrollment

100

Registered

2020-07-30

Start date

2020-08-17

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N39.42 N89.9

Interventions

Group 1: The laser treatment consists of a standardized dual phase protocol for the vaginal epithelium using the Erbium:YAG Laser on the pelvic floor with a defined wavelength of 2940nm. Group 2: plac

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
The main target value is the measurement of urge symptoms, evaluated by the OAB Symptom Score (time difference from baseline). 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

Measure	Time frame
Reduction of nighttime frequency, reduction of urge incontinence, improvement of symptoms of vaginal atrophy, improvement in quality of life. 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. 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).	—

Measure

Time frame

Reduction of nighttime frequency, reduction of urge incontinence, improvement of symptoms of vaginal atrophy, improvement in quality of life. 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. 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).

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Countries

Germany

Contacts

Public ContactAnne-Katrin Belz

St. Josefs Hopsital Wiesbaden Frauenklinik

akbelz@joho.de0611-177-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026