Stress Urinary Incontinence Clinical Trial
Official title:
Pilot Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence
This is a prospective, pilot clinical study involving two study groups. This study is
designed to demonstrate that the study treatment meets primary efficacy and safety endpoints.
The treatment involves radiofrequency treatment to address symptoms of stress urinary
incontinence.
After receiving the study treatment, subjects will be followed out to 12 months
post-treatment. At the Screening Visit, and at each designated follow-up timepoint, subjects
will be asked to complete a variety of questionnaires, provide a patient diary, and undergo
an objective assessment for urine loss.
This is a prospective, pilot clinical study involving two study groups. Subjects meeting the
all the inclusion criteria and none of the exclusion criteria will be enrolled in the study.
Subjects will receive a single SUI treatment; subjects in Group 2 will receive two SUI
Treatments.
At the Screening Visit, and at each pre-designated study follow-up timepoint, subjects will
be asked to complete several quality of life questionnaires related to the treated condition.
In addition, subjects will provide a bladder voiding diary for review and data collection,
and a pad weight test will be conducted and results collected.
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