NCT04707690

IUL Study A Randomized Sham - Controlled Clinical Study

Intraurethral Laser Therapy for Stress Urinary Incontinence: A Randomized Sham - Controlled Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Intraurethral laser therapy	The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.
DEVICE	Intraurethral SHAM laser therapy	The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.

Timeline

• Start date: 2021-01-08
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2021-01-13
• Last updated: 2024-01-18

Locations

1 site across 1 country: Austria