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Intraurethral/Intravaginal 2940 nm Erbium Laser Treatment For Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:
Pilot Single-masked, Randomized, 3-arm Parallel Study Assessing the Tolerability, Safety and Efficacy of Intraurethral/Intravaginal 2940 nm Er:YAG Laser Treatment For Stress Urinary Incontinence

Clinical Trial Summary

Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence.

Clinical Trial Description

This study is a prospective, randomized, 3-arm parallel pilot study. Study subjects will be women currently experiencing female stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (SMUI) with a degree of intrinsic sphincter deficiency for a minimum duration of 6 months prior to enrolment. Diagnosis of SUI with a degree of intrinsic sphincter deficiency will be performed using urodynamic and clinical assessment.

Subjects will undergo sham, intravaginal, and the combination of intravaginal and intraurethral treatment with the 2940 nm Er:yttrium aluminum garnet Er:YAG laser at two time points, 4 weeks apart. Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence through 6 months follow-up and extend to 12 months follow-up.

Secondary objective is to assess the effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments using subjective and objective measures, as well as improvement in quality of life through 6 months follow-up and extend to 12 months follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03676894
Study type Interventional
Source Fotona d.o.o.
Contact Branka Korosec, PhD
Phone +386015009185
Email branka.korosec@fotona.com
Status Recruiting
Phase N/A
Start date June 4, 2018
Completion date December 4, 2021
View Details
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