Prospective randomized controlled clinical trial investigating ER:YAG laser therapy in patients with stress urinary incontinence - LABEL-W

Universitätsklinik Bonn, Klinik für Gynäkologie und gyn. Onkologie0 个研究点目标入组 138 人开始时间: 2026年7月16日最近更新: 2026年8月3日

适应症

试验速览

暂无简介。

•Pre- and postmenopausal patients with stress urinary incontinence (SUI I–II)
•Age = 18 years
•Written informed consent from the patient
•Negative pregnancy test (urine ß-hCG test)
•Treatment-naive with regard to laser treatments for stress urinary incontinence
•Patient is able to follow the study instructions and attend the required study visits (compliance)
•Women of childbearing age: willing to use a reliable method of contraception during treatment

•Concurrent participation in interventional studies or participation in an interventional study up to 30 days after the last intervention in that study
•SUI Grade III, POP-Q = 2, urge incontinence, overactive bladder, neurogenic bladder dysfunction
•Abnormal Pap smear, dysplasia of the vagina/vulva/cervix
•Injuries/active infections in the area to be treated (vagina, introitus, vulva), previous surgeries in the area to be treated
•Unexplained vaginal bleeding
•Vaginal lesions and scars
•Active or recent (within 30 days) infection of the urogenital tract (urinalysis) or hematuria
•Malignancies of the anogenital region
•Presence of an autoimmune disease
•Use of photosensitive medications
•Current or planned pregnancy or breastfeeding during the 6-month treatment phase, childbirth within the past year
•Known or ongoing abuse of medications, drugs or alcohol

发起方

Universitätsklinik Bonn, Klinik für Gynäkologie und gyn. Onkologie