Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.

Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence: a Prospective Observational Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Laser Therapy; Urinary Incontinence , Stress

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Jan Dvorak, M.D. Ph.D.; Phone Number: 00420224967577; Email: jan.dvorak2@vfn.cz

Study Locations

• Czechia
  • Prague, Czechia, 142 00
    • Recruiting
    • General University Hospital in Prague
    • Contact: Jan Dvorak, M.D. Ph.D.; Phone Number: 00420224967425; Email: jan.dvorak2@vfn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Adult female patients attending the participating outpatient clinical site who have independently elected to undergo self-paid vaginal laser treatment as routine clinical care for pure stress urinary incontinence or stress-predominant mixed urinary incontinence. Patients must have urodynamically demonstrated stress urinary incontinence without detrusor overactivity. Patients will be screened consecutively during the recruitment period, and those meeting the eligibility criteria will be invited to participate.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Stress urinary incontinence; A prospective cohort of 40 women aged 18 years or older with urodynamically demonstrated pure stress urinary incontinence or stress-predominant mixed urinary incontinence, without detrusor overactivity. Participants independently choose vaginal laser treatment as routine clinical care before being offered study enrollment. Treatment comprises three non-ablative Er laser sessions (Fotona SP Dynamis Pro; IncontiLase, SMOOTH mode) at 4-6-week intervals. Standardized 4D transperineal ultrasound and clinical assessments are performed before the first session and at 1, 3, and 6 months after the final session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From in Craniocaudal Urethrovesical Junction Mobility	Within-participant change in craniocaudal urethrovesical junction (UVJ) mobility, measured in millimeters using standardized 4D transperineal ultrasound. UVJ position is measured relative to a horizontal reference line through the posteroinferior margin of the pubic symphysis, with cranial positions coded as negative and caudal positions as positive. Mobility is calculated as UVJ position during maximal Valsalva minus UVJ position at rest. Change is calculated as mobility at 1 month after the final laser session minus baseline mobility. Negative values indicate reduced mobility.	Baseline (before the first laser session) and 1 month after the final laser session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Craniocaudal Urethrovesical Junction Mobility at 3 and 6 Months After the Final Laser Session	Within-participant change in craniocaudal urethrovesical junction (UVJ) mobility, measured in millimeters using standardized 4D transperineal ultrasound. Mobility is calculated as UVJ position during maximal Valsalva minus UVJ position at rest. Change is follow-up mobility minus baseline mobility, assessed separately at 3 and 6 months. Negative values indicate reduced mobility.	Baseline (before the first laser session) and 3 and 6 months after the final laser session.
Change From Baseline in Urethrovesical Junction Position at Rest	Change in craniocaudal urethrovesical junction position at rest, measured in millimeters using 4D transperineal ultrasound relative to a horizontal line through the posteroinferior margin of the pubic symphysis. Cranial positions are negative and caudal positions positive. Change is follow-up position minus baseline position.	Baseline (before the first laser session) and 1, 3, and 6 months after the final laser session.
Change From Baseline in Mid-Urethral Hypoechoic Cross-Sectional Area at Rest	Change in the cross-sectional area of the hypoechoic mid-urethral region at rest, measured in square millimeters by manual tracing on 4D transperineal ultrasound. The measurement plane is perpendicular to the urethral axis at 50% of sonographic urethral length. Change is follow-up area minus baseline area.	Baseline (before the first laser session) and 1, 3, and 6 months after the final laser session.
Change From Baseline in ICIQ-UI SF Total Score	Change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) total score. Scores range from 0 to 21, with higher scores indicating greater urinary incontinence severity and impact. Change is follow-up score minus baseline score; negative values indicate improvement.	Baseline (before the first laser session) and 1, 3, and 6 months after the final laser session.
Patient Global Impression of Improvement Category	Distribution of responses on the Patient Global Impression of Improvement (PGI-I), a 7-point scale assessing perceived change in urinary incontinence compared with the pretreatment condition. Scores range from 1 (very much better) to 7 (very much worse), with 4 indicating no change. Lower scores indicate greater perceived improvement.	1, 3, and 6 months after the final laser session

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: October 26, 2026
• First Submitted That Met QC Criteria: October 26, 2026
• First Posted (Actual): October 30, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: stress urinary incontinence; transperineal ultrasound; vaginal laser; urethrovesical junction; bladder-neck mobility
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: 6/5/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No