PMID- 30178536
OWN - NLM
STAT- MEDLINE
DCOM- 20191018
LR  - 20191018
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Linking)
VI  - 37
IP  - 8
DP  - 2018 Nov
TI  - Treatment with an adjustable long-term implant for post-prostatectomy stress 
      incontinence: The ProACT pivotal trial.
PG  - 2854-2859
LID - 10.1002/nau.23802 [doi]
AB  - AIMS: This paper presents 18-month follow-up results for patients enrolled in a 
      pivotal study conducted to support an FDA premarket approval application (PMAA). 
      The trial 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. A total of 124 subjects met study criteria and 123 underwent ProACT 
      implantation from July 2005 through June 2007, of whom 98 completed 18-month 
      follow-up. Endpoints included 24-h pad weight, Incontinence Quality of Life 
      Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), 
      residual volume, and device or procedure-related adverse events (AEs). RESULTS: 
      The mean surgical time was 32 min. Statistically significant improvements during 
      follow-up were observed in 24-h pad weight, for which the cohort mean pre-implant 
      urine loss was 399 g, which was reduced at 18 months to 160 g (P < 0.001). 
      Reductions in pad weight were observed across all levels of pre-implant SUI 
      severity. Significant improvements were also seen in quality of life as measured 
      by the I-QOL (P < 0.001) as well as measures of urinary function and pad count. 
      One procedure-related serious adverse event (SAE), retention, was reported among 
      the 124 subjects; the SAE was resolved without clinical meaningful sequalae. 
      CONCLUSIONS: These results demonstrate the safety and efficacy of this newly 
      FDA-approved therapy, showing significant improvements in objective and 
      subjective measures of SUI in mild, moderate, and severely incontinent male 
      patients. The duration of the implant procedure is short, and complications are 
      mild and easily resolvable.
CI  - (c) 2018 Wiley Periodicals, Inc.
FAU - Nash, Steven
AU  - Nash S
AD  - Kansas City Urology Care, Leawood, Kansas.
FAU - Aboseif, Sherif
AU  - Aboseif S
AD  - Kaiser Permanente-Los Angeles, Los Angeles, California.
FAU - Gilling, Peter
AU  - Gilling P
AD  - Urology Bay of Plenty, Tauranga, New Zealand.
FAU - Gretzer, Mathew
AU  - Gretzer M
AD  - University of Arizona, Tucson, Arizona.
FAU - Samowitz, Harvey
AU  - Samowitz H
AD  - The Pelvic Clinic, Pembroke Pines, Florida.
FAU - Rose, Marc
AU  - Rose M
AD  - Indian River Urology, Vero Beach, Florida.
FAU - Slutsky, Joel
AU  - Slutsky J
AD  - Urological Surgeons, Kankakee, Illinois.
FAU - Siegel, Steven
AU  - Siegel S
AD  - Metro Urology, Woodbury, Minnesota.
FAU - Tu, Le Mai
AU  - Tu LM
AD  - CHUS-Fleurimont, Quebec, Canada.
LA  - eng
GR  - Uromedica, Inc./International
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180903
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Postoperative Complications/etiology/*surgery
MH  - Prospective Studies
MH  - Prostatectomy/*adverse effects
MH  - Prostatic Neoplasms/surgery
MH  - *Prostheses and Implants
MH  - Quality of Life
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Urinary Incontinence, Stress/etiology/*surgery
OTO - NOTNLM
OT  - incontinence
OT  - prosthesis
OT  - quality of life
EDAT- 2018/09/05 06:00
MHDA- 2019/10/19 06:00
CRDT- 2018/09/05 06:00
PHST- 2018/06/26 00:00 [received]
PHST- 2018/07/18 00:00 [accepted]
PHST- 2018/09/05 06:00 [pubmed]
PHST- 2019/10/19 06:00 [medline]
PHST- 2018/09/05 06:00 [entrez]
AID - 10.1002/nau.23802 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2018 Nov;37(8):2854-2859. doi: 10.1002/nau.23802. Epub 2018 Sep 
      3.