1. Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT™
- Author
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Steven Siegel, Sherif R. Aboseif, Le Mai Tu, Harvey Samowitz, Mathew Gretzer, Marc Rose, Joel Slutsky, Steven Nash, and Peter J. Gilling
- Subjects
Male ,medicine.medical_specialty ,Stress incontinence ,Urology ,medicine.medical_treatment ,Urinary Incontinence, Stress ,030232 urology & nephrology ,Urinary incontinence ,Prosthesis ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Internal medicine ,Surveys and Questionnaires ,Medicine ,Humans ,Postoperative Period ,Prospective Studies ,Adverse effect ,Aged ,Aged, 80 and over ,Prostatectomy ,030219 obstetrics & reproductive medicine ,business.industry ,Incidence (epidemiology) ,Prostatic Neoplasms ,Prostheses and Implants ,Middle Aged ,Urinary function ,medicine.disease ,Treatment Outcome ,Quality of Life ,Neurology (clinical) ,Implant ,medicine.symptom ,business ,Follow-Up Studies - Abstract
AIMS This paper presents 4-year follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The study evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). METHODS The clinical study involved 11 clinical sites and enrolled 160 subjects, all male. A total of 124 subjects met study criteria and 123 were implanted with ProACT. Baseline and outcomes for 68 patients who completed 4-year follow-up visits are reported. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and incidence and severity of device or procedure-related adverse events. RESULTS Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the mean pre-implant urine loss was 293 g, which was reduced at 4 years to 73 g (P
- Published
- 2018