Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)

Conditions: Stress Urinary Incontinence

Sex: Female

Ages: 18 Years – N/A

Healthy volunteers: 1

Phase: NA

Enrollment: 50

Sponsor: Cork University Maternity Hospital

Summary

To investigate the efficacy of combined laser and HITS treatment for female stress urinary incontinence (SUI)

Eligibility Criteria

Inclusion Criteria:Adult female, 18 years of age or olderClinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom (SUI or MUI)Exclusion Criteria:Very severe urinary incontinence (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) ICIQ-UI )score at baseline >18 or Pad test > 50 gr)PregnancyBMI>35Acute urinary tract infections (UTIs)History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infectionProlapse grade 2 or higherHistory of radiotherapy for cervical or uterine cancerMedical condition that may interfere with participants' compliance to the protocolMedical condition for which the HITS and laser therapy are contraindicatedPrevious laser or HITS treatment for SUI

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05670392). StuddyBuddy aggregates publicly available trial information.