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

2026年11月4日更新者：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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Jan Dvorak, M.D. Ph.D.
电话号码：00420224967577
邮箱：jan.dvorak2@vfn.cz

学习地点

捷克语
- - Prague、捷克语、142 00
    - 招聘中
    - General University Hospital in Prague
    - 接触：
      
      Jan Dvorak, M.D. Ph.D.
      
      电话号码：00420224967425
      
      邮箱：jan.dvorak2@vfn.cz

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
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.

团体/队列

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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change From in Craniocaudal Urethrovesical Junction Mobility 大体时间：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.

次要结果测量

结果测量	措施说明	大体时间
Change From Baseline in Craniocaudal Urethrovesical Junction Mobility at 3 and 6 Months After the Final Laser Session 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Charles University, Czech Republic

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年10月26日

首先提交符合 QC 标准的

2026年10月26日

首次发布 (实际的)

2026年10月30日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

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