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

November 4, 2026 updated by: Jan Dvořák, Charles University, Czech Republic

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Czechia
      • Prague, Czechia, 142 00
        • Recruiting
        • General University Hospital in Prague
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From in Craniocaudal Urethrovesical Junction Mobility
Time Frame: Baseline (before the first laser session) and 1 month after the final laser session.

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Craniocaudal Urethrovesical Junction Mobility at 3 and 6 Months After the Final Laser Session
Time Frame: Baseline (before the first laser session) and 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
Time Frame: Baseline (before the first laser session) and 1, 3, and 6 months after the final laser session.

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
Time Frame: Baseline (before the first laser session) and 1, 3, and 6 months after the final laser session.

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
Time Frame: Baseline (before the first laser session) and 1, 3, and 6 months after the final laser session.

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
Time Frame: 1, 3, and 6 months after the final laser session

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charles University, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings