IUL Study A Randomized Sham - Controlled Clinical Study

Status Recruiting

Clinical Trial Summary

Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.

Clinical Trial Description

Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option. Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI. Design: randomized double blinded sham - controlled clinical study Study population: women which have been diagnosed with SUI I-II°, aged between 18-80 years. Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy. Sample size: A sample size of 20 women, 8 per group including a 20% Drop Out Rate, was calculated. Primary outcome: impact of SUI on the VAS scale 3 months after laser therapy versus sham laser therapy. Secondary study outcomes were defined as subjective SUI, objective SUI, QoL, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04707690
Study type	Interventional
Source	Medical University of Graz
Contact	Daniela Gold, MD PhD
Phone	0043316 385 81437
Email	daniela.gold@medunigraz.at
Status	Recruiting
Phase	N/A
Start date	January 8, 2021
Completion date	January 1, 2025

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