Vaginal Laser therapy for Treatment of Stress Urinary Incontinence

Not Applicable

• Conditions: stress urinary incontinence; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12624000458538
• Lead Sponsor: Anna Rosamilia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 147

Inclusion Criteria

•Adult Female, 18 years of age or older
•Slight to severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women.
•No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training
•Capable of providing informed consent and able to return for follow-up.
•Normal Cervical screening test within last five years

Exclusion Criteria

•Very severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women.
•Diagnosis of OAB wet, based on UDI-6, question 2 urine leakage related to the feeling of urgency” – answer Moderately OR Greatly”.
•Presence of vesicovaginal fistula
•Fecal incontinence
•Pregnant subjects or women less than 12-months post-partum
•Actively breastfeeding or ceased breastfeeding less than three menstrual cycles
•Any previous prolapse surgery
•Any previous incontinence surgery
•Any radical pelvic surgery
•Transvaginal mesh or sling implant
•Pre-existing bladder pathology including prior radiation treatment.
•Previous surgery in the treatment area in the last year.
•Active genital infection
•Subject presenting with a cervical screening test demonstrating cervical dysplasia or another reason for colposcopic assessment
•Systemic steroids use within the last 3 months
•Pelvic organ prolapse (POP) > stage 2 according to pelvic organ prolapse quantification system
•Diagnosis of collagen disorders eg. Benign joint hypermobility/Ehlers-Danlos/Marfan etc.
•Serious systemic disease or any chronic condition that could interfere with study compliance.
•Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
•Other contraindications to laser treatment: UTI, injury or bleeding in areas of tissue to be treated (vestibule and anterior vaginal wall), Morbid obesity (BMI>40), Diabetes, A history of Photosensivity disorder or use of photosensitivity medications, abnormal scarring, excessive sun exposure, preoperative histology findings indicative of malignancy.
•Unwillingness or inability to complete follow-up schedule
•Unwillingness or inability to give Informed Consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified