Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559423
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Combined Non-ablative ErYAG Laser and Magnetic Stimulation for Treatment of Female Urinary Incontinence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combined Non-ablative ErYAG Laser and High Intensity Tesla Magnetic Stimulation HITS for Treatment of Female Urinary Incontinence A Single-centre Single-arm Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single-arm pilot study aims to investigate the efficacy and safety of a combined non-ablative ErbiumYttrium-Aluminium-Garnet ErYAG laser and High Intensity Tesla magnetic Stimulation HITS treatment for female urinary incontinence The study involves 25 women diagnosed with mild to moderate stress or mixed urinary incontinence Participants will receive three vaginal ErYAG laser treatments and six HITS sessions The primary objective is to improve symptoms of urinary incontinence as measured by changes in scores on two questionnaires compared to baseline Secondary objectives include improvement in sexual function durability of improvement in urinary incontinence symptoms at 3- and 6- month follow-up patient-reported improvement and discomfort during treatment
Detailed Description:
The aim of this single-centre single-arm pilot study is to investigate the combined effects of vaginal ErYAG laser and HITS treatment on urinary incontinence UI in women The study will involve 25 women suffering from mild to moderate stress urinary incontinence or mixed urinary incontinence The aim of the study is to investigate whether the combination of non-ablative ErYAG laser therapy and HITS can have a synergistic effect in relieving UI symptoms Participants will undergo three sessions of intravaginal laser treatment according to the IncontiLase ErYAG laser protocol and six HITS sessions The laser treatments will take place one month apart while the HITS sessions will take place twice a week for three weeks after the last laser treatment
Primary endpoints include improvement in UI symptoms as measured by changes in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form ICIQ-UI SF and Questionnaire for Urinary Incontinence Diagnosis QUID scores from baseline to post-treatment Secondary endpoints include improvement in sexual function as measured by the Female Sexual Function Index FSFI durability of improvement in UI symptoms 3 and 6 months after treatment patient-reported global impression of improvement Patient Global Impression of Improvement PGI-I and treatment-related discomfort as measured by the Visual Analog Scale VAS for pain
The study also includes rigorous safety assessments and monitoring of adverse events or complaints during and after the treatments Recruitment of participants will ensure that they meet certain inclusion criteria such as adult women with a clinical diagnosis of stress or mixed UI as well as exclusion criteria to minimize risks and improve compliance
Statistical analysis will be performed using various tests to check the data for normality and distribution The results of the study should provide valuable insight into the efficacy and safety of combining laser and HITS treatments for female urinary incontinence and potentially provide a new non-invasive treatment option for this condition
Primary endpoints include improvement in UI symptoms as measured by changes in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form ICIQ-UI SF and Questionnaire for Urinary Incontinence Diagnosis QUID scores from baseline to post-treatment Secondary endpoints include improvement in sexual function as measured by the Female Sexual Function Index FSFI durability of improvement in UI symptoms 3 and 6 months after treatment patient-reported global impression of improvement Patient Global Impression of Improvement PGI-I and treatment-related discomfort as measured by the Visual Analog Scale VAS for pain
The study also includes rigorous safety assessments and monitoring of adverse events or complaints during and after the treatments Recruitment of participants will ensure that they meet certain inclusion criteria such as adult women with a clinical diagnosis of stress or mixed UI as well as exclusion criteria to minimize risks and improve compliance
Statistical analysis will be performed using various tests to check the data for normality and distribution The results of the study should provide valuable insight into the efficacy and safety of combining laser and HITS treatments for female urinary incontinence and potentially provide a new non-invasive treatment option for this condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None