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NCT07907016
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Conditions: Urinary Incontinence , Stress, Laser Therapy
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 40
Sponsor: Charles University, Czech Republic
Location: General University Hospital in Prague Prague
Summary
This prospective single-center observational cohort study will assess changes in urethrovesical junction (UVJ) mobility and urethral morphology after vaginal Er:YAG laser treatment in 40 adult women with pure stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence.
Participants will independently choose self-paid laser treatment as routine clinical care before being offered study participation. Treatment comprises three sessions at 4-6-week intervals. Standardized 4D transperineal ultrasound and clinical assessments will be performed at baseline and 1, 3, and 6 months after the final session.
The primary outcome is change in craniocaudal UVJ mobility, measured in millimeters, from baseline to 1 month after the final session. Secondary outcomes include UVJ mobility at 3 and 6 months, UVJ position, mid-urethral morphology, patient-reported outcomes, cough stress test results, adverse events, and initiation of additional SUI treatment. Exploratory analyses will assess associations between ultrasound changes and clinical outcomes.
Eligibility Criteria
Inclusion Criteria:
* Female sex.
* Age 18 years or older.
* Pure stress urinary incontinence or stress-predominant mixed urinary incontinence. In women with mixed urinary incontinence, the stress component must be the dominant and most bothersome symptom.
* Urodynamically demonstrated stress urinary incontinence.
* Absence of detrusor overactivity on urodynamic testing.
* Independent decision to undergo self-paid vaginal laser treatment as routine clinical care, made before the offer of study participation.
* Ability to complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
* Ability to perform a technically acceptable Valsalva maneuver.
* Willingness to attend the scheduled follow-up visits.
* Written informed consent to study participation.
Exclusion Criteria:
* Predominant overactive bladder or predominant urgency urinary incontinence.
* Previous surgery for stress urinary incontinence.
* Previous vaginal laser treatment.
* Previous pelvic organ prolapse surgery.
* Pelvic Organ Prolapse Quantification (POP-Q) stage II or greater in any compartment.
* Current pessary use at enrollment.
* Active pelvic floor physiotherapy at enrollment.
* Previous pelvic radiotherapy.
* Pregnancy.
* Unexplained genital bleeding.
* Pelvic malignancy.
* Any other contraindication to vaginal laser treatment.
* Active urinary tract or vaginal infection. Enrollment and laser treatment will be deferred until the infection has resolved.
Source: ClinicalTrials.gov (NCT07907016). StuddyBuddy aggregates publicly available trial information.