4D Transperineal Ultrasound to Check UVJ Mobility After Vaginal Laser for Stress Incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational study enrolling 40 adult women with pure stress urinary incontinence or stress-predominant mixed incontinence. Participants receive self-paid vaginal Er:YAG laser treatment in routine care, with three sessions at 4-6 week intervals, and undergo standardized 4D transperineal ultrasound and clinical assessments at baseline and 1, 3, and 6 months after the final session. The primary outcome is the change in craniocaudal UVJ mobility from baseline to 1 month after the final treatment; secondary outcomes include UVJ mobility at later time points, UVJ position, mid-urethral morphology, patient-reported outcomes, cough stress test results, adverse events, and need for additional SUI treatment. Exploratory analyses will be performed to explore associations between imaging changes and clinical outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• General University Hospital in Prague
  Prague, Czechia Recruiting

Study contacts

• Study coordinator: Jan Dvorak, M.D. Ph.D.
• Email: jan.dvorak2@vfn.cz
• Phone: 00420224967577

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.