Hundley AF, Wu JM, Visco AG A comparison of perineometer to brink score for assessment of pelvic floor muscle strength. Am J Obstet Gynecol. 2005 May;192(5):1583-91.
Kammerer-Doak D, Rizk DE, Sorinola O, Agur W, Ismail S, Bazi T Mixed urinary incontinence: international urogynecological association research and development committee opinion. Int Urogynecol J. 2014 Oct;25(10):1303-12. doi: 10.1007/s00192-014-2485-8. Epub 2014 Aug 5. Review.
Lamin E, Parrillo LM, Newman DK, Smith AL Pelvic Floor Muscle Training: Underutilization in the USA. Curr Urol Rep. 2016 Feb;17(2):10. doi: 10.1007/s11934-015-0572-0. Review.
Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27. Review.
Monteiro S, Riccetto C, Araújo A, Galo L, Brito N, Botelho S Efficacy of pelvic floor muscle training in women with overactive bladder syndrome: a systematic review. Int Urogynecol J. 2018 Nov;29(11):1565-1573. doi: 10.1007/s00192-018-3602-x. Epub 2018 Apr 11.
Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res. 1994 Oct;3(5):291-306.
Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9.
Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
