A randomized trial comparing vaginal laser therapy and pelvic floor physical therapy for treating women with stress urinary incontinence

Abstract

IntroductionFemale stress urinary incontinence (SUI) is considered a major public health issue. Physical therapy is an important conservative treatment; however, it is primarily limited by poor long‐term compliance. Furthermore, surgical treatment entails significant risks. Therefore, new treatment techniques must be identified.ObjectiveTo compare the use of laser therapy and pelvic floor (PF) physical therapy for treating postmenopausal women with SUI.MethodsThis pilot study enrolled 40 women with a clinical and urodynamic diagnosis of SUI who were randomized into two groups: those who received erbium‐doped yttrium–aluminum–garnet (Er:YAG) laser therapy implemented over three sessions with a 1‐month interval (n = 20) and those who received physical therapy with supervision twice a week for 3 months (n = 20). In total, 16 women completed the treatment in each group. The patients were assessed for PF function using the modified Oxford scale and for pelvic organ prolapse using the Pelvic Organ Prolapse Quantification System. The 1‐h pad test and quality of life questionnaires, King's Health Questionnaire (KHQ), and Incontinence Quality of Life (IQOL) were also administered. Patients were re‐evaluated at 1, 3, 6, and 12 months after treatment.ResultsThe mean patient age was 62.7 ± 9.1 and 57.9 ± 6.1 years, median Oxford score at baseline was 3 (2–4.5) and 4 (3–4), mean IQOL score was 79.8 ± 17 and 74.6 ± 18 for physical therapy group (PTG) and laser group (LG), respectively. For the amount of urine leak in the 1‐h pad test evaluation, we found significance for the interaction of group and time points only for the Laser intragroup. The cure rate, that is, the rate of reaching an insignificant score in the pad test, at 6 and 12 months was 43.75% and 50% in PTG and 62.5% and 56.25% in the LG, respectively (p > 0.05). IQOL scores demonstrated considerable improvement in both groups (p > 0.05). Upon comparing the initial and follow‐up results, the LG showed an improvement at all consultations, whereas the PTG showed improvements at 1, 3, and 6 months but not at 12 months after treatment. KHQ analysis revealed a considerable improvement in the quality of life (QOL) of patients over time, with no substantial difference between the groups. QOL comparison before and after treatment revealed that the vaginal LG improved more consistently in some domains. Only the PTG showed a significant increase in the mean Oxford score from pretreatment to 1 and 3 months after treatment (p < 0.001 and p = 0.002, respectively). However, no statistically significant difference was observed between the groups.ConclusionBoth treatments are safe and have a positive influence on the impact of UI on patients' QOL. The laser caused a greater reduction in the urinary loss, as measured using the weight of pad test, at 6‐month and 12‐month after treatment without difference with PTG at the end of the follow‐up.

Current Treatment of Stress Urinary Incontinence by Bulking Agents and Laser Therapy—An Update

“…Eight RCTs investigated laser therapy for SUI, three of them with the Erbium:YAG laser with SMOOTH-mode settings [ 84 , 85 , 86 ], and five with the fractional CO 2 laser ( Table 2 ). Six RCTs evaluated laser vs. placebo (sham) control, one study had a third arm to test radiofrequency [ 87 ], and one RCT compared laser with pelvic floor physical training [ 86 ] and another with promestriene and lubricant [ 75 ].…”

“…Eight RCTs investigated laser therapy for SUI, three of them with the Erbium:YAG laser with SMOOTH-mode settings [ 84 , 85 , 86 ], and five with the fractional CO 2 laser ( Table 2 ). Six RCTs evaluated laser vs. placebo (sham) control, one study had a third arm to test radiofrequency [ 87 ], and one RCT compared laser with pelvic floor physical training [ 86 ] and another with promestriene and lubricant [ 75 ]. Subjective study outcome analysis was often based on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score, and objective outcomes were often analyzed by the one-hour pad weight test.…”

“…Subjective study outcome analysis was often based on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score, and objective outcomes were often analyzed by the one-hour pad weight test. In most studies, the subjective ICIQ-UI SF score significantly improved after laser therapy [ 75 , 84 , 87 , 88 , 89 ], and the objective pad weight significantly decreased after laser therapy ( Table 2 ) [ 85 , 86 , 87 , 88 ]. Laser was significantly better than sham treatment in 50% (3/6) of the studies regarding the ICIQ-UI SF score [ 84 , 87 , 88 ], and in 75% (3/4) of the studies regarding the pad weight [ 85 , 87 , 88 ].…”

“…Laser was significantly better than sham treatment in 50% (3/6) of the studies regarding the ICIQ-UI SF score [ 84 , 87 , 88 ], and in 75% (3/4) of the studies regarding the pad weight [ 85 , 87 , 88 ]. No significant outcome differences were found between laser and promestriene [ 75 ], laser and radiofrequency [ 87 ], or laser and pelvic floor physical training ( Table 2 ) [ 86 ].…”