CO2 surgical laser for treatment of stress urinary incontinence in women: a randomized controlled trial - 23/08/22
Abstract |
Background |
Stress urinary incontinence is a common condition that can be treated conservatively and/or surgically. Given the risks of surgery, developing effective nonsurgical treatment options would be beneficial. Some studies have suggested that laser therapy may improve or cure stress urinary incontinence. However, there is a lack of sham-controlled randomized controlled trials to judge treatment efficacy.
Objective |
This study aimed to compare the effects of CO2 vaginal laser vs sham therapy for treating stress urinary incontinence.
Study Design |
This was a multicenter, participant-blinded, sham-controlled, parallel group (1:1) superiority randomized controlled trial performed in outpatient clinics in 2 hospitals. We included women aged 18 to 80 years with objective and subjective stress urinary incontinence. 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 treatment was performed using an identical technique with a deactivated pedal.
The primary outcome was the subjective stress urinary incontinence rate (proportion with leak with cough, sneeze, or laughter) at 3 months after completion of treatment. Secondary outcomes included objective stress urinary incontinence, change in the disease-specific patient-reported outcomes, health-related quality of life, and adverse effects. Categorical outcomes were compared using the chi square test and continuous outcomes using analysis of covariance, adjusting for the baseline score.
Results |
There were 52 participants who received laser and 49 who received sham treatment. One participant in each group withdrew from the study before the endpoint, and 2 participants in the laser group did not participate in the follow-up visits. Participant mean age was 53 (34–79) years. Mean body mass index was 26.1 (18.1–49.6); 90% were vaginally parous. At 3 months, there was no difference between the sham and active treatment arm in subjective stress urinary incontinence (46 [96%] vs 48 [98%]; relative risk, 0.98 [95% confidence interval, 0.91–1.05]; P=.55) or in objective stress urinary incontinence (37 [80%] vs 33 [80%]; relative risk, 0.99 [95% confidence interval, 0.81–1.23]; P=.995). Patient-reported outcomes and health-related quality of life were also comparable between the groups. Vaginal bleeding occurred in 3 participants after laser and 1 participant after sham treatment. Pain during treatment did not differ between laser and sham treatment.
Conclusion |
We were unable to show an improvement in stress urinary incontinence after CO2 vaginal laser therapy compared with sham treatment.
Le texte complet de cet article est disponible en PDF.Key words : female urinary incontinence, nonsurgical treatment of urinary incontinence, stress urinary incontinence, vaginal laser
Plan
The authors report no conflict of interest. |
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Partial funding was obtained during the study from the Continence Foundation of Australia (M21005/3176612). The funder did not play any role in conducting the study, writing the manuscript, or the decision to submit for publication. |
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Clinical trial registration through Australian New Zealand Clinical Trials Registry i) Date of registration: January 18, 2017 ii) Date of initial participant enrolment: February 1, 2017 iii) Clinical trial identification number: ACTRN12617000099325 iv) URL of registration site: www.anzctr.org.au/ v) Data sharing information: Not available |
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Cite this article as: Alexander JW, Karjalainen P, Ow LL, et al. CO2 surgical laser for treatment of stress urinary incontinence in women: a randomized controlled trial. Am J Obstet Gynecol 2022;227:473.e1-12. |
Vol 227 - N° 3
P. 473.e1-473.e12 - septembre 2022 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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