Barber MD, Walters MD, Bump RC Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13.
Emile SH, Elfeki H, Shalaby M, Sakr A, Sileri P, Wexner SD Perineal resectional procedures for the treatment of complete rectal prolapse: A systematic review of the literature. Int J Surg. 2017 Oct;46:146-154. doi: 10.1016/j.ijsu.2017.09.005. Epub 2017 Sep 7. Review.
Jayne DG, Schwandner O, Stuto A Stapled transanal rectal resection for obstructed defecation syndrome: one-year results of the European STARR Registry. Dis Colon Rectum. 2009 Jul;52(7):1205-12; discussion 1212-4. doi: 10.1007/DCR.0b013e3181a9120f.
Khaikin M, Wexner SD Treatment strategies in obstructed defecation and fecal incontinence. World J Gastroenterol. 2006 May 28;12(20):3168-73. Review.
Kluivers KB, Hendriks JC, Shek C, Dietz HP Pelvic organ prolapse symptoms in relation to POPQ, ordinal stages and ultrasound prolapse assessment. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1299-302. doi: 10.1007/s00192-008-0634-7. Epub 2008 May 9.
Podzemny V, Pescatori LC, Pescatori M Management of obstructed defecation. World J Gastroenterol. 2015 Jan 28;21(4):1053-60. doi: 10.3748/wjg.v21.i4.1053. Review.
Rao SS Dyssynergic defecation. Gastroenterol Clin North Am. 2001 Mar;30(1):97-114. Review.
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.
