An observational study in Urinary Incontinence , Stress and Laser Therapy, sponsored by Charles University, Czech Republic. Recruiting at 1 site in Czechia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Charles University, Czech Republic · Observational
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 40 is below the median of 130 across 127 observational studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Charles University, Czech Republic is the lead sponsor of 228 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Baseline (before the first laser session) and 1 month after the final laser session.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1, 3, and 6 months after the final laser session
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.
Of 39 non-industry observational studies under Urinary Incontinence, Stress, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 107. This study's planned 35 months is close to that.
Counting every sponsor, half of 48 studies reached it within 45 months; a quarter within 18 and three quarters within 107.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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