IUL Study A Randomized Sham - Controlled Clinical Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stress Urinary Incontinence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective randomized sham - controlled trialMasking: Double (Participant, Care Provider)Masking Description: Eligible patients will receive written and oral information about the study. After informed consent patients will be randomized into the intraurethral laser treatment group or sham laser group using the internet based program "randomizer", at a 1.1 ratio without stratification. Patients and the person performing the laser treatment will not aware of the treatment given. The laser devices can be used as a placebo laser blocking the laser beam with a plug.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT04707690
- Collaborators
- Not Provided
- Investigators
- Not Provided
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