Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS)
| Autor: | Karin M. Vermeulen, Chantal M.C.R. Panman, Marian Wiegersma, Yvonne Lisman-van Leeuwen, Marjolein Y. Berger, Janny H. Dekker, Aaltje J. Schram, Embert J. Messelink, Boudewijn J. Kollen |
|---|---|
| Přispěvatelé: | Damage and Repair in Cancer Development and Cancer Treatment (DARE), Life Course Epidemiology (LCE), Methods in Medicines evaluation & Outcomes research (M2O) |
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Pessary
Research design medicine.medical_specialty SYMPTOMS DISORDERS medicine.medical_treatment CONTINENCE SOCIETY Pragmatic randomized controlled trial Pelvic Floor Muscle General Biochemistry Genetics and Molecular Biology law.invention Quality of life Randomized controlled trial law QUALITY-OF-LIFE Humans Medicine TERMINOLOGY Aged Primary health care business.industry SHORT-FORM Obstetrics and Gynecology WOMEN Pelvic Floor Pelvic floor muscle training Middle Aged Pessaries STANDARDIZATION DYSFUNCTION Exercise Therapy Surgery Pelvic organ prolapse Patient recruitment body regions Research Design INCONTINENCE Physical therapy Female Watchful waiting business Sexual function |
| Zdroj: | Maturitas, 77(2), 168-173. ELSEVIER IRELAND LTD |
| ISSN: | 0378-5122 |
| DOI: | 10.1016/j.maturitas.2013.10.014 |
| Popis: | Pelvic floor muscle training (PFMT) and pessaries are commonly used in the conservative treatment of pelvic organ prolapse (POP). Because there is a lack of evidence regarding the optimal choice between these two interventions, we designed the "Pelvic Organ prolapse in primary care: effects of Pelvic floor muscle training and Pessary treatment Study" (POPPS). POPPS consists of two parallel open label randomized controlled trials performed in primary care, in women aged >= 55 years, recruited through a postal questionnaire. In POPPS trial 1, women with mild POP receive either PFMT or watchful waiting. In POPPS trial 2, women with advanced POP receive either PFMT or pessary treatment. Patient recruitment started in 2009 and was finished in December 2012. Primary outcome of both POPPS trials is improvement in POP-related symptoms. Secondary outcomes are quality of life, sexual function, POP-Q stage, pelvic floor muscle function, post-void residual volume, patients' perception of improvement, and costs. All outcomes are measured 3, 12, and 24 months after the start of treatment. Cost-effectiveness will be calculated based on societal costs, using the PFDI-20 and the EQ-5D as outcomes. In this paper the POPPS design, the encountered challenges and our solutions, and participant baseline characteristics are presented. For both trials the target numbers of patients in each treatment group are achieved, giving this study sufficient power to lead to promising results. (C) 2013 Elsevier Ireland Ltd. All rights reserved. |
| Databáze: | OpenAIRE |
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