AIMS: The purpose of this study was to determine whether a percutaneous needle electrode (PNE) technique or a surgical first stage lead placement (FSLP) better predicted whether a patient would progress to implantation of a pulse generator (IPG) in older urge incontinent women. METHODS:Thirty subjects > or =55 years with refractory urge incontinence who had been selected to undergo a test stimulation procedure were randomized to either PNE or FSLP. Thirteen underwent PNE placement and seventeen underwent FSLP placement. If during the test stimulation period subjects had greater than 50% improvement in their incontinence parameters they qualified for permanent lead and/or IPG implantation of the Interstim device. RESULTS: Twenty-one subjects (70%) responded to the test stimulation and underwent implantation, 15/17 (88%) in the FSLP group and 6/13 (46%) in the PNE group. Subjects who were randomized to the FSLP group were significantly more likely to proceed to implantation of the IPG (P = 0.02) than those in the PNE group. There was no significant difference in demographics, pre-test stimulation incontinence parameters or post-stimulation visual analog pain scores between the randomized groups or between test stimulation responders and non-responders. When comparing FSLP and PNE responders, there was no significant difference in the percent improvement in 24-hr pad weight, daily pad usage, or daily incontinence. CONCLUSION:FSLP better predicted progression to implantation of the IPG than a test stimulation with a PNE in an older urge incontinent cohort. Copyright 2006 Wiley-Liss, Inc.
RCT Entities:
AIMS: The purpose of this study was to determine whether a percutaneous needle electrode (PNE) technique or a surgical first stage lead placement (FSLP) better predicted whether a patient would progress to implantation of a pulse generator (IPG) in older urge incontinent women. METHODS: Thirty subjects > or =55 years with refractory urge incontinence who had been selected to undergo a test stimulation procedure were randomized to either PNE or FSLP. Thirteen underwent PNE placement and seventeen underwent FSLP placement. If during the test stimulation period subjects had greater than 50% improvement in their incontinence parameters they qualified for permanent lead and/or IPG implantation of the Interstim device. RESULTS: Twenty-one subjects (70%) responded to the test stimulation and underwent implantation, 15/17 (88%) in the FSLP group and 6/13 (46%) in the PNE group. Subjects who were randomized to the FSLP group were significantly more likely to proceed to implantation of the IPG (P = 0.02) than those in the PNE group. There was no significant difference in demographics, pre-test stimulation incontinence parameters or post-stimulation visual analog pain scores between the randomized groups or between test stimulation responders and non-responders. When comparing FSLP and PNE responders, there was no significant difference in the percent improvement in 24-hr pad weight, daily pad usage, or daily incontinence. CONCLUSION: FSLP better predicted progression to implantation of the IPG than a test stimulation with a PNE in an older urge incontinent cohort. Copyright 2006 Wiley-Liss, Inc.
Authors: Anthony G Visco; Linda Brubaker; Holly E Richter; Ingrid Nygaard; Marie Fidela Paraiso; Shawn A Menefee; Joseph Schaffer; John Wei; Toby Chai; Nancy Janz; Cathie Spino; Susan Meikle Journal: Contemp Clin Trials Date: 2011-10-08 Impact factor: 2.226
Authors: Cindy L Amundsen; Holly E Richter; Shawn A Menefee; Yuko M Komesu; Lily A Arya; W Thomas Gregory; Deborah L Myers; Halina M Zyczynski; Sandip Vasavada; Tracy L Nolen; Dennis Wallace; Susan F Meikle Journal: JAMA Date: 2016-10-04 Impact factor: 56.272
Authors: Maria Paola Bertapelle; Mario Vottero; Giulio Del Popolo; Marco Mencarini; Edoardo Ostardo; Michele Spinelli; Antonella Giannantoni; Anna D'Ausilio Journal: World J Urol Date: 2014-09-14 Impact factor: 4.226