Vaginal laser not found superior to sham for SUI treatment

Vaginal laser not found superior to sham for SUI treatment | Image Credit: © ibreakstock - © ibreakstock - stock.adobe.com.

The erbium-doped yttrium aluminum garnet laser (Er: YAG laser) is not superior to sham for managing female stress urinary incontinence (SUI) at 6 months, according to a recent study published in the American Journal of Obstetrics & Gynecology.¹

Impact of SUI

At least 40% of adult women experience SUI, presenting as weakened pelvic floor muscles (PFMs) involved in bladder support.² This adversely impacts women’s well-being, including their ability to work, social activities, and intimate relationships.¹ A success rate of over 80% for up to 5 years has been observed for surgical treatment.

Despite these benefits, surgery has been linked to certain risks and complications. Er: YAG laser therapy has been proposed as an alternative method.

“Given the limited, conflicting research available, the wide availability of laser therapy despite no endorsement by any gynecology/urology professional society… and great public interest and need for effective nonsurgical SUI treatments, we sought to determine the efficacy of Er: YAG laser as a therapy for SUI,” wrote investigators.

Evaluating SUI treatment

The double-blind randomized sham-controlled clinical trial was conducted at a tertiary care center. Participants included adult women with symptomatic SUI, documented using standardized questionnaires, a 3-day voiding diary, a positive cough test, or urinary leakage with cough.

Exclusion criteria included pelvic organ prolapse with a point of maximum descent from 1 cm above the introitus to below it. Participants were randomized 1:1 to receive either active Er: YAG laser treatment or sham treatment. Those in the latter group received 2 sham sessions, 6 weeks apart.

Similarly, patients in the laser treatment group received 2 intravaginal laser sessions of approximately 20 minutes, 6 weeks apart. Active laser treatment utilized the preset laser parameters of the IncontiLase protocol for the G-runner.

Outcome measures

The research coordinator obtained screening and baseline data, while a blinded research assistant obtained questionnaire data. Assessments at 6 weeks and 6 months postpartum were performed by a blinded physician.

Subjective cure at 6 months following the second treatment session was reported as the primary outcome. This was determined by the response of “never” to the question “How often does urine leak?” Objective and subjective UI measures, pain with treatment, quality of life, and adverse events (AEs) were reported as secondary outcomes.

No superiority

There were 144 women included in the final analysis, 76 of whom were in the Er: YAG laser group and 68 were in the sham treatment group. Similar baseline characteristics were reported between groups, though patients in the laser treatment group had a mean age of 50.00±9.35 years vs 56.00±11.73 years in the sham treatment group.

The primary outcome was achieved by 91% of the laser treatment group vs 97% of the sham treatment group at 6 months. There was 1 case of patient withdrawal because of pain in the laser treatment group. Also, rates of subjective cure did not significantly differ between groups.

Quality of life was assessed with the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and King’s Health Questionnaire (KHQ). Significant differences in the ICIQ-SF score and KHQ domains 4, 7, and 9 were observed in the laser treatment group at 6 weeks, but no other differences were observed for secondary measures.

Implications

There were also no significant differences between groups at 6 months vs baseline. Most AEs did not require treatment to be resolved within a few days. However, pain scores were significantly increased in patients receiving laser treatment. Overall, the data highlighted a lack of superiority form Er: YAG laser vs sham for SUI treatment.

“The current study does not support the use of Er: YAG laser for the treatment of SUI. Future studies on women with mild, moderate, or severe SUI are needed to determine whether laser therapy plays a role in treating different subgroups of women,” wrote investigators.

References

1. Lee P, Perruzza D, Edell H, et al. Double-blind randomized controlled trial of Er: YAG vaginal laser to treat female stress urinary incontinence. Am J Obstet Gynecol. 2025;232:541.e1-12. doi:10.1016/j.ajog.2024.11.021
2. Wu JM. Stress Incontinence in Women. N Engl J Med. 2021;384(25):2428-2436. doi:10.1056/NEJMcp1914037