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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT05952258
Brief Summary:
The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with stress urinary incontinence.
Detailed Description:
A double-blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm will be conducted; followed by an open label trial at 3 months for any sham treatment arm participants who do not meet treatment success.
The primary goal is to compare the subjective success rates for the resolution of stress urinary incontinence (SUI) for the magnetic stimulation treatment at 3 months. Secondary aims include an assessment of complications, resolution of SUI symptoms, patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 158 patients. At the 3-month post treatment evaluation, the treatment allocation will be unmasked. Patients will be followed post treatment up to 2 years.
Study:
NCT05952258
Study Brief:
Protocol Section:
NCT05952258