Key messages
• In the short term, vaginal lasers may make little or no difference to the number of continent women, and while vaginal lasers may improve patient-reported incontinence compared to sham, the improvement is small and may not make a noticeable difference for patients. We have very low confidence in these results.
• In the medium term, there may be more continent women among those who received vaginal laser compared to those who received sham; however, there may be little to no difference in patient-reported incontinence. We have very low confidence in these results.
• There were no major unwanted effects reported in women receiving vaginal laser, sham or lubricant, or topical oestrogen.
What is stress urinary incontinence?
Stress urinary incontinence is uncontrolled leakage of urine on effort or exertion.
What are treatments for stress urinary incontinence?
Stress urinary incontinence has traditionally been treated with pelvic floor physical therapy, topical oestrogen creams, vaginal inserts or pessaries (a removable device inserted into the vagina to support the pelvic organs), and surgeries such as urethral injections or urethral slings. Vaginal lasers are a clinic-based therapy that in recent years has been explored as a treatment for stress urinary incontinence, but their safety and effectiveness remain uncertain. Some professional medical societies have issued warnings against the use of energy-based devices like vaginal lasers for treating urinary incontinence due to the lack of strong safety and effectiveness data.
What did we want to find out?
We wanted to find out if vaginal lasers are better than sham or control treatments (such as topical lubricant) or topical treatment (such as topical oestrogen) in improving incontinence outcomes in the short and long term. We also wanted to find out if vaginal lasers are associated with any unwanted effects.
What did we do?
We searched for studies that compared vaginal laser with sham or control treatments (such as topical lubricant) or topical treatment (such as topical oestrogen) in women with stress urinary incontinence. We compared and summarised the results of the studies and rated our confidence in the evidence based on factors such as study methods and sizes.
What did we find?
We found nine studies involving a total of 689 women with stress urinary incontinence. Nine studies compared vaginal lasers to either sham or lubricant, and one study compared vaginal lasers to topical oestrogen. Seven studies reported short-term data (less than one year), and two studies reported short- and medium-term data (one to five years).
We have very low confidence in the following results.
• In the short term, the number of continent women (objective measure as reported by the researchers) may be similar between vaginal laser and sham or lubricant. In the medium term, there may be more continent women among those undergoing vaginal laser versus sham or lubricant.
• In the short term, vaginal lasers may improve patient-reported incontinence compared to sham, but the improvement is small and may not make a noticeable difference for patients. In the medium term, there may be similar improvement in patient-reported continence measures between vaginal laser and sham treatments.
• There may be similar improvement in patient-reported urinary incontinence between women who received vaginal laser and those who received topical oestrogen cream.
• There were no major unwanted effects reported in women receiving vaginal laser, sham or lubricant, or topical oestrogen.
What are the limitations of the evidence?
We have very low confidence in the evidence because it is possible that people in the studies were aware of which treatment they were getting; not all studies provided data about everything that we were interested in; and there are not enough studies to be certain about the results. The included studies measured success in different ways and at different time points, which made combining the results challenging.
How up-to-date is this evidence?
The evidence is current to 29 April 2024.
Read the full abstract
Stress urinary incontinence (SUI) in women is common and can have a profound impact on an individual's quality of life. Vaginal lasers, designed for treating vulvovaginal atrophy, have been explored as a clinic-based option for treating SUI. However, the effect of vaginal lasers on SUI remains unclear.
Objectives
To assess the effects of vaginal lasers for treating SUI in women and to summarise the principal findings of relevant economic evaluations.
Search strategy
We performed a comprehensive search using the Cochrane Incontinence Specialised Register (searched 29 April 2024). The Register contains trials identified from multiple databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, and WHO ICTRP (all within the Register). We also handsearched journals and conference proceedings and searched the reference lists of relevant articles. We identified published reports of relevant economic evaluations through electronic literature searches, and performed a literature search for a brief economic commentary (BEC), but found no studies of economic evaluations that compare vaginal lasers with other treatments.
Selection criteria
We included randomised controlled trials of women with SUI assessing therapy with a vaginal laser versus sham or control treatments or topical treatments.
Data collection and analysis
Two review authors independently performed study selection, data extraction, and risk of bias assessment, with arbitration from a third review author as needed. We performed statistical analyses using a random-effects model. We rated the certainty of evidence according to the GRADE approach.
Main results
We screened 227 references and included nine studies that reported outcomes on 689 women with SUI. The studies were conducted in Europe, North America, and South America. Five studies utilised CO₂ laser and four utilised Er:YAG laser therapy, delivered from one to three treatments occurring 28 to 45 days apart. The studies compared laser therapy to sham or topical therapy; two studies had three comparator arms. The time points for all the reported outcomes ranged from three to 12 months and were therefore considered either short term (less than one year) or medium term (one to five years). Generally, the certainty of evidence was downgraded due to concerns of risk of bias and imprecision and judged to be very low.
Vaginal lasers versus sham or control treatments (such as topical lubricant)
All nine studies, reporting outcomes for 689 women, investigated this comparison.
There may be no difference in the number of continent women between women who underwent vaginal laser compared to those who underwent sham or control treatments in the short term; however, the CI is sufficiently wide enough to include both greater and fewer continent women with vaginal laser compared with sham or control treatment (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.72 to 3.10; I² = 81%; 3 studies, 196 women; very low-certainty evidence). There may be more continent women among those who underwent vaginal laser compared to those who underwent sham or control treatments in the medium term (one to five years, RR 2.88, 95% CI 1.48 to 5.60; I² = not applicable; 1 study, 76 women; very low-certainty evidence).
Vaginal lasers may improve patient-reported incontinence measures (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) compared to sham or control treatment in the short term (mean difference (MD) −1.42 points, 95% CI −2.41 to −0.43; I² = 54%; 8 studies, 632 women; very low-certainty evidence). However, the point estimate for improvement does not meet the prespecified minimally clinical importance difference. This implies that the improvement may not represent a clinically significant (noticeable) difference for patients. There may be similar improvement in patient-reported continence measures between vaginal laser and sham in the medium term (MD −1.62 points, 95% CI −5.64 to 2.40; I² = not applicable; 1 study, 76 women; very low-certainty evidence), but the evidence is very uncertain.
There were no major adverse events in either the vaginal laser or sham or control treatment groups.
Vaginal lasers versus topical treatments (such as topical oestrogen)
One study involving 48 women provided evidence for this comparison.
The number of continent women (objective measure as reported by the trialists) at less than one year after treatment was not reported.
We are uncertain whether the improvement in patient-reported incontinence (ICIQ-UI SF) at less than one year differed between women who underwent vaginal laser versus those who received topical oestrogen (MD −1.61, 95% CI −4.71 to 1.49; 1 study, 48 women; very low-certainty evidence).
There were no major adverse events in either the vaginal laser or topical oestrogen arm in the short term.
Authors' conclusions
Vaginal lasers may have little to no effect on SUI as measured by both clinical assessment and patient-reported outcome measures in the short term (less than one year) compared to sham or control treatments or topical treatments, but the evidence is very uncertain. In the medium term, while the evidence is very uncertain, there may be more continent women among those who received vaginal laser compared to those who received sham; however, there may be little to no difference between groups in patient-reported incontinence. There were no major adverse events associated with any intervention or comparator. Future studies that incorporate more medium- and long-term data, data stratified by type of incontinence (stress, mixed, or urgency) and by symptom severity or patient comorbidities will improve the quality of evidence.
