Geometrical Stepper-Guided Navigation System for ProACT Implant under Transrectal Ultrasound Control: Preliminary Data

Crivellaro, Simone; Tosco, Lorenzo; Palazzetti, Anna; Abbinante, Maria; Martínez, Guillermo; Kocjancic, Ervin; Frea, Bruno

doi:10.1159/000341991

Cited by 9 publications

(2 citation statements)

References 41 publications

(30 reference statements)

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“…Studies on ProACT also suggest that patients with prior radiation have lower efficacy results than nonirradiated patients . and have a higher risk of urethral erosion . The only consequence of urethral erosion of the ProACT balloon is a worse functional result and explant of the affected device .…”

Section: Discussionmentioning

confidence: 99%

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Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta‐analysis

Larson

Jhaveri

Yeung

2019

Neurourology and Urodynamics

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Aims First, to evaluate the efficacy of adjustable balloon devices or adjustable continence therapy (ProACT) in the treatment for male stress urinary incontinence (SUI). Second, to investigate the safety profile and rates of adverse events associated with the implantation of adjustable balloon devices. Method A review of the literature was performed by searching the PubMed database with the most applicable search terms. We narrowed included studies with adult male patients with SUI; outcomes included pads or pad weight per day and quality of life (QOL) questionnaires, as well as safety outcomes. Results In total, 19 studies were included with a total of 1264 patients and 4517 patient‐years of follow‐up data (mean follow‐up time 3.6 years). ProACT implantation resulted in an incontinence QOL improvement of 30.8 points from baseline. At baseline, patients on average were using 4.0 pads per day (PPD) (95% confidence interval [CI]: 2.6‐5.4), which was reduced to an average of 1.1 PPD (95% CI: 0.5‐1.7) after ProACT implantation. The number of patients that were considered “dry” was 60.2% (95% CI: 54.2%‐65.9%) and the number of patients who were found to be either “dry” or improved greater than 50% was 81.9% (95% CI: 74%‐87.8%). Conclusions Implantation of adjustable balloon devices is efficacious and safe for the treatment of male SUI. Given the minimal invasiveness of the therapy, adjustable balloon devices may be a serious option as a first‐line treatment in nonirradiated patients with SUI who are not ideal candidates for the artificial urinary sphincter.

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Section: Discussionmentioning

confidence: 99%

“…13,15,16,21 and have a higher risk of urethral erosion. 3,9,[11][12][13]15,21,23 The only consequence of urethral erosion of the ProACT balloon is a worse functional result and explant of the affected device. 21 Patients can have the explanted balloon replaced as soon as the tissues have healed or be implanted with an AUS.…”

Section: Discussionmentioning

confidence: 99%