Introduction and hypothesis: The aim of our study was to evaluate the effect of a combination of innovative pelvic floor muscle training (iPFMT) and duloxetine compared with the use of duloxetine alone on women with stress urinary incontinence (SUI) after 12 weeks of treatment.
Methods: We conducted a parallel multicentre study with randomized intervention in 45 national urological outpatient clinics. Patients with an enrolment ratio of 1:1 were divided into the experimental and control groups. The following were used for evaluation: incontinence episode frequency (IEF)/week, the International Consultation on Incontinence Questionnaire (ICIQ-SF), the Urinary Incontinence Quality of Life Scale (I-QoL) and the Patient Global Impression of Improvement (PGI-I). The experimental group received oral treatment with duloxetine (a daily dose of 40 mg BID) and innovative pelvic floor muscle training (iPFMT). The control group received only oral treatment with duloxetine at a daily dose of 40 mg BID.
Results: The number of women who were evaluated was 158. The control group comprised 79 women with an average age of 56.8 ± 13.8 years and the experimental group comprised 79 women with an average age of 53.4 ± 11.9 years. There were no significant differences in pre-treatment parameters. For the intent-to-treat analysis after 12 weeks' treatment, significant differences were observed between the experimental vs. control group (p < 0.001) for the following variables: IEF/week decrease (66.7% vs. 50.0%); ICIQ-UI SF decrease (8.3 ± 3.8 vs. 9.7 ± 4.2); PGI-I (70.8% vs. 65.6%); I-QoL score increase (19.3% vs. 6.6%).
Conclusion: The addition of iPFMT to duloxetine treatment improves SUI syndrome in women compared with duloxetine treatment alone.
Registration: Clinical Trials.gov NCT04140253.
Keywords: Duloxetine; Innovative pelvic floor exercise; Stress urinary incontinence.