Transurethral non-ablative Erbium: YAG Laser for mild to moderate stress incontinence after radical prostatectomy—a randomized controlled trial

Lv T1, Song X1, Fang W1, Ji X1, Li Z1, Peng W1, Lv J1, Vizintin Z2

Research Type

Clinical

Abstract Category

Male Stress Urinary Incontinence (Post Prostatectomy Incontinence)

Abstract 40
Urology 2 - Male Stress Urinary Incontinence
Scientific Podium Short Oral Session 4
Thursday 18th September 2025
11:22 - 11:30
Parallel Hall 2
Stress Urinary Incontinence New Devices Male Clinical Trial
1. Department of Urology, Gongli Hospital of Shanghai, China, 2. Laser and Health Academy, Ljubljana, Slovenia
Presenter
Links

Abstract

Hypothesis / aims of study
To evaluate effectiveness and safety of transurethral Erbium: YAG laser treatment for mild to moderate postprostatectomy incontinence.
Study design, materials and methods
This is a prospective randomized controlled trial executed in two clinical sites in which eligible patients with mild and moderate urinary incontinence after radical prostatectomy were enrolled and randomly divided into two groups: the treatment group and the control group. The patients in treatment group received transurethral Erbium: YAG laser in non-ablative SMOOTH mode. Six laser sessions with 3 weeks interval were performed. The control group received biofeedback and electrostimulation therapy in 30 minutes sessions three times a week for 15 consecutive weeks. The primary outcome measures were the change in a) Incontinence Episodes Frequency in 72 hours (IEF) and b) 1 hour pad test. The secondary outcome measures used to evaluate the therapeutic effect were c) International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF); d) Incontinence Quality of Life Questionnaire (I-QoL); e) Patient Global Impression of Improvement (PGI-I) and urodynamic indicators f) Abdominal Leak Point Pressures (ALPP) and g) Maximum Urethral Closure Pressure (MUCP). The total treatment effectiveness was calculated as a combination of the results of the ICIQ-UI SF and 1 hour pad test and the scores were divided into four categories (Cured / Significant Effect, Effective, Minor Effect and Ineffective). The occurrence of adverse reactions after treatment were observed at each visit and follow-ups. The assessments of outcomes were made before treatment, at 9 weeks of treatment, at the end of treatment (18 weeks), and at 6 months after the end of treatment. The study was executed in accordance with the Declaration of Helsinki for research and was approved by appropriate Ethics Committee and all the patients signed the informed consent.
Results
Between December 2020 and June 2023, a total of 79 patients who met the inclusion criteria were recruited and randomly assigned to treatment (n=42) or control group (n=37). Baseline characteristics in terms of average age, average post-surgery time and urinary incontinence measures between treatment and control group showed no significant difference between groups (p > 0.05). The primary outcome measures the IEF and 1-hour pad test values in the laser group showed larger reduction than control group at all time points and the difference between the two groups was statistically significant (p < 0.01). All secondary outcome measures also showed significant improvement in comparison to the baseline and the results of laser group were significantly better than of control group (p<0.01) in all three time points. After 18 weeks, 76.19% of patients in laser group and 32.43% of patients in control group had PGI-I scores ≤ 3 points ("Very much better" or "Much better" or "A little better"). The total effectiveness of laser group and control group at 6 months follow-up, compared to baseline, were 66.67% and 29.73%, respectively. No adverse reactions such as infection, hematoma, tissue burns, dysuria or new urge incontinence were observed in any of the groups.
Interpretation of results
We show in this study that the transurethral non-ablative Er:YAG laser improves the mild to moderate SUI in post radical prostatectomy patients significantly better than biofeedback and electrostimulation therapy as measured by various objective and subjective measurement tools.
Concluding message
Transurethral non-ablative Er: YAG laser therapy for mild to moderate SUI after radical prostatectomy is simple, safe and effective, and patient satisfaction is high. We believe that the use of this laser application should be considered as an optional minimally invasive treatment for mild to moderate SUI after radical prostatectomy. The major limitations of this study are short follow-up period and small number of participants. Additional clinical studies are needed to further evaluate the long-term efficacy of this therapy.
Figure 1 1-hour pad test difference in comparison to the baseline levels for the Er:YAG laser group and control group at 9 and 18 weeks of treatment and after 6 months follow-up (FU). The difference was significant at each time point.
References
  1. Kretschmer A, Hübner W, Sandhu JS, et al. Evaluation and management of postprostatectomy incontinence: a systematic review of current literature. Eur Urol Focus. 2016; 2(3):245-259
  2. Mariotti G, Sciarra A, Gentilucci A, et al. Early recovery of urinary continence after radical prostatectomy using early pelvic floor electrical stimulation and biofeedback associated treatment. J Urol. 2009;181(4):1788-93.
  3. Lu Jianwei, Lu Tingting, Si Junwen et al. The efficacy of transurethral Er:YAG erbium laser in the treatment of women with mild to moderate stress urinary incontinence. J Mod Urol. 2019;04:268-271
Disclosures
Funding This study was sponsored by the Demonstration Pilot Project of Traditional Chinese Medicine Inheritance and Innovation Development in Pudong New Area(YC-2023-0405); Top-level Clinical Discipline Project of Shanghai Pudong(PYWgf2021-06) Clinical Trial Yes Public Registry No RCT Yes Subjects Human Ethics Committee Ethics Committee of Gongli Hospital of Shanghai Pudong New Area (20220322) Helsinki Yes Informed Consent Yes
09/07/2025 21:25:14