A randomized interventional parallel study to evaluate the effect of pelvic floor muscle training with stabilization exercises of high and low intensity in women with stress urinary incontinence: The PELSTAB study

Magdaléna Hagovská, Peter Urdzík, Ján Švihra, Magdaléna Hagovská, Peter Urdzík, Ján Švihra

Abstract

Introduction: The effect of different intensities of pelvic floor muscle training (PFMT) assessed by 2D/3D ultrasound (USG) have not been sufficiently monitored in the literature. The objective of the study will be to evaluate the effect of this intervention by assessing the change in incontinence episode frequency, hiatal area (HA) and hiatal diameter by 2D/3D USG and quality of life over 12 weeks of treatment.

Methods: Using a randomized interventional parallel study, patients will be assigned to groups A and B using simple software randomization according to odd and even patient sequence numbers. The following methods will be used for evaluation: change in incontinence episode frequency, power and endurance of pelvic floor muscles assessed by perineometer (in cmH2O), HA (in cm) during contraction, Valsalva manoeuvre assessed by 3D USG, hiatal diameter assessed by 2D USG, the Incontinence Quality of Life scale (I-QoL) and the Patient Global Impression of Improvement score (PGI-I).

Interventions: Group A, high-intensity PFMT 5 times a week for 30 minutes per day. Group B, low-intensity PFMT twice a week for 15 minutes per day. The duration of the intervention will be 12 weeks.

Discussion: The study protocol presents the starting points, design, and methods of the PELSTAB Study. We expect that, after 12 weeks of high-intensity PFMT, women with stress urinary incontinence will have significantly less incontinence episode frequency, better reduction of HA during contraction and Valsalva manoeuvre, higher power and endurance of pelvic floor muscles and better quality of life compared to the group with low-intensity PFMT.

Registration: This study was registered in the ClinicalTrials.govNCT04340323.

Conflict of interest statement

The authors report no conflicts of interest.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/7373635/bin/medi-99-e21264-g003.jpg

References

    1. Abrams P, Andersson KE, Apostolidis A, et al. 6th International Consultation on Incontinence. Recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence. Neurourol Urodyn 2018;37:2271–2.
    1. Bo K, Frawley HC, Haylen BT, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Neurourol Urodyn 2017;36:221–44.
    1. Bo, K., Berghmans B, Morkved S, Van Kampen M. Evidence – based physical therapy for the pelvic floor- 2nd Edition. Churchill Livingstone, 2014. 446 p. ISBN 9780702060731.
    1. Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J 2010;21:5–26.
    1. Kim EY, Kim SY, Oh DW. Pelvic floor muscle exercises utilizing trunk stabilization for treating postpartum urinary incontinence: randomized controlled pilot trial of supervised versus unsupervised training. Clin Rehabil 2012;26:132–41.
    1. Dietz HP, Shek C, Clarke B. Biometry of the pubovisceral muscle and levator hiatus by 3D pelvic floor ultrasound. Ultrasound. Obstet Gynecol 2005;25:580–5.
    1. Dietz HP, Wong V, Shek KL. Simplified method for determinating hiatal biometry. Aust NZ J Obstet Gynecol 2011;51:540–3.
    1. Tosun OC, Solmaz U, Ekin A, et al. Assessment of the effect of pelvic floor exercises on pelvic floor muscle strength using ultrasonography in patients with urinary incontinence: a prospective randomized controlled trial. J Phys Ther Sci 2016;28:360–5.
    1. Tosun OC, Kaya Mutlu E, Ergenoglu AM, et al. Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial. Clin Rehabil 2015;29:525–37.
    1. Avery K, Donovan J, Peters TJ, et al. ICIQ: A brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004;23:322–30.
    1. Klovning A, Avery K, Sandvik H, et al. Comparison of two questionnaires for assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn 2009;28:411–5.
    1. Coyne K, Revicki D, Hunt T, et al. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res 2002;11:563–74.
    1. Coyne KS, Payne C, Bhattacharyya SK, et al. The impact of urinary urgency and frequency on health related quality of life in overactive bladder: results from a national community survey. Value Health 2004;7:455–63.
    1. Laycock J, Jerwood D. Pelvic floor muscle asssessment: the PERFECT scheme. Physiotherapy 2001;87:631–42. ISSN 0031-9406.
    1. Padoa A, Rosenbaum T. The Overactive Pelvic Floor. Springer, 2016. 346 p. ISBN 978-3-319-22150-2.
    1. Rahmani N, Mohseni-Bandpei MA. Application of perineometer in the assessment of pelvic floor muscle strength and endurance: a reliability study. J Bod Mov Ther 2011;15:209–14.
    1. Bushnell DM, Martin ML, Summers KH, et al. Quality of life of women with urinary incontinence: Cross-cultural performance of 15 language versions of the I-QOL. Qual Life Res 2005;14:1901–13.
    1. Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98–101.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren