Amundsen CL, Romero AA, Jamison MG, Webster GD Sacral neuromodulation for intractable urge incontinence: are there factors associated with cure? Urology. 2005 Oct;66(4):746-50. doi: 10.1016/j.urology.2005.04.031.
Banakhar M, Hassouna M Percutaneous Nerve Evaluation Test Versus Staged Test Trials for Sacral Neuromodulation: Sensitivity, Specificity, and Predictive Values of Each Technique. Int Neurourol J. 2016 Sep;20(3):250-254. doi: 10.5213/inj.1630498.249. Epub 2016 Sep 23.
Bannowsky A, Wefer B, Braun PM, Junemann KP Urodynamic changes and response rates in patients treated with permanent electrodes compared to conventional wire electrodes in the peripheral nerve evaluation test. World J Urol. 2008 Dec;26(6):623-6. doi: 10.1007/s00345-008-0307-7. Epub 2008 Jul 16.
Blandon RE, Gebhart JB, Lightner DJ, Klingele CJ Re-operation rates after permanent sacral nerve stimulation for refractory voiding dysfunction in women. BJU Int. 2008 May;101(9):1119-23. doi: 10.1111/j.1464-410X.2007.07426.x. Epub 2008 Jan 10.
Borawski KM, Foster RT, Webster GD, Amundsen CL Predicting implantation with a neuromodulator using two different test stimulation techniques: A prospective randomized study in urge incontinent women. Neurourol Urodyn. 2007;26(1):14-8. doi: 10.1002/nau.20332.
Trial Time for Percutaneous Nerve Evaluation in Patients Undergoing Sacral Neuromodulation for Urgency Urinary Incontinence or Urgency-frequency: a Randomized Control Trial
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.
