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

4 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Tipo de estudio

De observación

Inscripción (Estimado)

40

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jan Dvorak, M.D. Ph.D.
  • Número de teléfono: 00420224967577
  • Correo electrónico: jan.dvorak2@vfn.cz

Ubicaciones de estudio

  • Chequia
      • Prague, Chequia, 142 00
        • Reclutamiento
        • General University Hospital in Prague
        • Contacto:
          • Jan Dvorak, M.D. Ph.D.
          • Número de teléfono: 00420224967425
          • Correo electrónico: jan.dvorak2@vfn.cz

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From in Craniocaudal Urethrovesical Junction Mobility
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Craniocaudal Urethrovesical Junction Mobility at 3 and 6 Months After the Final Laser Session
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Charles University, Czech Republic

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

31 de diciembre de 2029

Finalización del estudio (Estimado)

31 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

26 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de octubre de 2026

Publicado por primera vez (Actual)

30 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 6/5/2025

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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