Stress Urinary Incontinence — Randomized Control Trial to Assess Postoperative Pain After Sling Placement
Citation(s)
Al-Hayek S, Abrams P Women's lower urinary tract function and dysfunction: definitions and epidemiology. Minerva Ginecol. 2004 Aug;56(4):311-25. Review.
Dogan E, Celiloglu M, Sarihan E, Demir A Anesthetic effect of intrauterine lidocaine plus naproxen sodium in endometrial biopsy. Obstet Gynecol. 2004 Feb;103(2):347-51.
Hunskaar S, Vinsnes A The quality of life in women with urinary incontinence as measured by the sickness impact profile. J Am Geriatr Soc. 1991 Apr;39(4):378-82. Erratum in: J Am Geriatr Soc 1992 Sep;40(9):976-7.
Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8.
Schatz H, Henriksson L Pain during the TVT procedure performed under local anesthesia. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Nov;14(5):347-9; discussion 349. Epub 2003 Sep 6.
Ulmsten U, Henriksson L, Johnson P, Varhos G An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6.
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.
