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A randomized, intervention parallel multicentre study to evaluate duloxetine and innovative pelvic floor muscle training in women with uncomplicated stress urinary incontinence—the DULOXING study

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Abstract

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.

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Acknowledgements

We thank the physians for their cooperation in the study.

List of physians from out-patient clinics in Slovakia: Barbora Spodniaková, Ľubomír Uherčík, Eva Šulcová, Juraj Barta, Daniel Fajtl, Milan Chalachan, Tomáš Danys, Vladimír Starovecký, Kamil Duranka, Dzmitry Lapatko, Lukáš Čmarada, Richard Ľuník, Miloš Pisák, Cyril Fedor, Oto Šoltés.

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Authors and Affiliations

  1. Department of Physiatry, Balneology, and Medical Rehabilitation, Institution-Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic

    Magdalena Hagovska

  2. Department of Urology, Institution-Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Bratislava, Slovak Republic

    Jan Svihra

  3. National Institute of Pediatric Diseases, Department of Pediatric Urology, Faculty of Medicine, Comenius University Bratislava, Bratislava, Slovak Republic

    Jan Breza Jr

  4. Department of Urology, University Hospital Bratislava, Bratislava, Slovak Republic

    Jozef Dubravicky

  5. Outpatient Clinic of Urology, Railway Hospital, Kosice, Slovak Republic

    Marek Vargovcak

Authors
  1. Magdalena Hagovska
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  2. Jan Svihra
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  3. Jan Breza Jr
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  4. Jozef Dubravicky
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  5. Marek Vargovcak
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Contributions

JS was responsible for the study design and methodology. MH was responsible for writing the article and preparing educational materials for the exercises. JS, MH, JB, JD and MV were responsible for coordinating centre and data management. MH, JS, JB, JD and MV read and approved the final manuscript.

Corresponding author

Correspondence to Jan Svihra.

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Hagovska, M., Svihra, J., Breza, J. et al. A randomized, intervention parallel multicentre study to evaluate duloxetine and innovative pelvic floor muscle training in women with uncomplicated stress urinary incontinence—the DULOXING study. Int Urogynecol J 32, 193–201 (2021). https://doi.org/10.1007/s00192-020-04516-w

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  • DOI: https://doi.org/10.1007/s00192-020-04516-w

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