Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03676894
Brief 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.
Study:
NCT03676894
Study Brief:
Protocol Section:
NCT03676894