NCT03676894

Intraurethral/Intravaginal 2940 Nm Erbium Laser Treatment for Stress Urinary Incontinence

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Fotona d.o.o. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Sham Fotona SP Dynamis	Female patients with SUI will be treated with non-ablative Er:YAG laser with Fotona SP Dynamis with sham handpiece.
DEVICE	Intravaginal Fotona SP Dynamis	Female patients with SUI will be treated intravaginaly with non-ablative Er:YAG laser with Fotona SP Dynamis
DEVICE	Intraurethral Fotona SP Dynamis	Female patients with SUI will be treated intraurethraly with non-ablative Er:YAG laser with Fotona SP Dynamis

Timeline

• Start date: 2018-06-04
• Primary completion: 2022-11-28
• Completion: 2023-05-23
• First posted: 2018-09-19
• Last updated: 2025-03-13

Locations

2 sites across 1 country: Canada