CO2 Surgical Laser for Treatment of Stress Urinary Incontinence in Women: A Randomized Controlled Trial
Abstract
BACKGROUND
Stress Urinary incontinence (SUI) is a common condition that can be treated conservatively and/or surgically. Given the risks of surgery, there would be benefits for patients to develop effective non-surgical treatment options. Some studies have suggested laser therapy may improve or cure SUI however there is a lack of sham-controlled randomised controlled trials (RCT) to judge treatment efficacy.
OBJECTIVE
To compare the effects of CO2 vaginal laser versus sham for the treatment of stress urinary incontinence (SUI).
STUDY DESIGN
This was a multi-centre, participant-blinded, sham-controlled parallel group (1:1) superiority RCT. It was performed in outpatient clinics in 2 hospitals. We included women aged 18-80 with objective and subjective SUI. Participants had undertaken or declined supervised pelvic floor muscle training. Intervention was performed using a CO2 fractionated vaginal laser. Participants underwent 3 treatments, 4 weeks apart, with increasing energy and density settings. Sham was performed using an identical technique with a deactivated pedal. The primary outcome was the subjective SUI rate (proportion with leak with cough, sneeze, or laughter) at 3 months after completion of treatment. Secondary outcomes included objective SUI, change in the disease specific patient reported outcomes (PRO), and generic quality of life (HRQOL) as well as adverse effects. Categorical outcomes were compared using the chi-squared test and continuous outcomes using…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 52 participants or records.
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