PURPOSE: To describe a new geometrical stepper-guided navigation system for positioning ProACT®. METHODS: The sizing of the stepper-guided navigation system was calculated using the distance from the ideal position of the device to anatomic referral points previously measured by ultrasound. The trocar and subsequently the device were maneuvered to the ideal position in accordance with the navigation system. MEASUREMENTS: Treatment efficacy was evaluated with daily pad count, 1-hour pad test, Incontinence Quality of Life questionnaire (IQoL), visual analog scale and overall impression. Complications, balloon volume and number of adjustments were reported at 1, 3, 6 and 12 months follow-up visits. RESULTS: Mean follow-up was 12 (range 3-19) months. Daily pad count showed 30 patients (71%) dry and 9 patients (21%) improved. 1 hour pad test showed 28 patients were dry (66%) and 11 patients improved (26%). IQoL increased from an average of 35.3 to 80. Average visual analog scale score was 8. Complications requiring device removal occurred in 3 patients (7%). Mean balloon volume was 3.1 ml. CONCLUSIONS: The stepper-guided navigation system to implant ProACT is feasible and extremely reproducible making this procedure more standardized.
PURPOSE: To describe a new geometrical stepper-guided navigation system for positioning ProACT®. METHODS: The sizing of the stepper-guided navigation system was calculated using the distance from the ideal position of the device to anatomic referral points previously measured by ultrasound. The trocar and subsequently the device were maneuvered to the ideal position in accordance with the navigation system. MEASUREMENTS: Treatment efficacy was evaluated with daily pad count, 1-hour pad test, Incontinence Quality of Life questionnaire (IQoL), visual analog scale and overall impression. Complications, balloon volume and number of adjustments were reported at 1, 3, 6 and 12 months follow-up visits. RESULTS: Mean follow-up was 12 (range 3-19) months. Daily pad count showed 30 patients (71%) dry and 9 patients (21%) improved. 1 hour pad test showed 28 patients were dry (66%) and 11 patients improved (26%). IQoL increased from an average of 35.3 to 80. Average visual analog scale score was 8. Complications requiring device removal occurred in 3 patients (7%). Mean balloon volume was 3.1 ml. CONCLUSIONS: The stepper-guided navigation system to implant ProACT is feasible and extremely reproducible making this procedure more standardized.
Authors: Javier C Angulo; Sandra Schönburg; Alessandro Giammò; Francisco J Abellán; Ignacio Arance; David Lora Journal: PLoS One Date: 2019-12-02 Impact factor: 3.240