N39.3
Conditions
Interventions
Group 1: Arm 1 (Laser Therapy):
• 3 sessions of ER:YAG laser therapy: two-phase treatment using a 2940 nm erbium:YAG laser (Asclepion Laser Technologies, Jena, Germany) according to a standardized pro
Sponsors
Universitätsklinik Bonn, Klinik für Gynäkologie und gyn. Onkologie
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pre- and postmenopausal patients with stress urinary incontinence (SUI I–II) 2. Age = 18 years 3. Written informed consent from the patient 4. Negative pregnancy test (urine ß-hCG test) 5. Treatment-naive with regard to laser treatments for stress urinary incontinence 6. Patient is able to follow the study instructions and attend the required study visits (compliance) 7. Women of childbearing age: willing to use a reliable method of contraception during treatment
Exclusion criteria
Exclusion criteria: 1. Concurrent participation in interventional studies or participation in an interventional study up to 30 days after the last intervention in that study 2. SUI Grade III, POP-Q = 2, urge incontinence, overactive bladder, neurogenic bladder dysfunction 3. BMI > 35 4. Abnormal Pap smear, dysplasia of the vagina/vulva/cervix 5. Injuries/active infections in the area to be treated (vagina, introitus, vulva), previous surgeries in the area to be treated 6. Unexplained vaginal bleeding 7. Vaginal lesions and scars 8. Active or recent (within 30 days) infection of the urogenital tract (urinalysis) or hematuria 9. Malignancies of the anogenital region 10. Presence of an autoimmune disease 11. Use of photosensitive medications 12. Current or planned pregnancy or breastfeeding during the 6-month treatment phase, childbirth within the past year 13. Known or ongoing abuse of medications, drugs or alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint describes the change in the ICIQ score at 6 months compared to baseline (hereinafter referred to as the change score). The ICIQ, for which the study is powered, is a validated questionnaire frequently used in clinical trials for SUI and represents a good objective measure. Completing the ICIQ questionnaire takes about 2 minutes and assesses the severity of stress incontinence using a score ranging from 0 to 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary endpoint measures the change in the score on the German Pelvic Floor Questionnaire. In addition to bladder function, the German Pelvic Floor Questionnaire also covers the domains of bowel function, prolapse symptoms, and sexuality, making it a good complement to the ICIQ. The German Pelvic Floor Questionnaire also assesses the impact of symptoms on patients’ quality of life. In addition, the change in the severity of urinary incontinence, as measured by the 1-hour pad test, is recorded as a further secondary endpoint. Another secondary endpoint describes the safety of ER:YAG laser therapy in patients with stress urinary incontinence (SUI I-II°) based on the recording of all adverse events that occur. | — |
Countries
Germany
Contacts
Public ContactDominique Könsgen-Mustea
Universitätsklinik Bonn, Klinik für Gynäkologie und gynäkologische Onkologie
Outcome results
None listed