The clinical global impressions scale: applying a research tool in clinical practice.
Joan Busner, Steven D Targum
https://pubmed.ncbi.nlm.nih.gov/20526405Actively Recruiting
Age: 18Years +
MALE
ID06239909
Clinical Outcomes of the Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery - Prospective Follow-up Study
Led by University Hospital Ostrava · Updated on 2024-02-02
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of the Victo adjustable artificial sphincter to treat male patients who have urinary incontinence following prostate surgery. This prospective academic study aims to evaluate how well the device works and its safety in managing severe incontinence in this group. This non-interventional study includes adult males who have already undergone implantation of the Victo artificial sphincter. Before surgery, patients receive standard diagnostic tests. After activation of the device, they will have follow-up visits at 3 months and then annually. Patients can also contact the study center at any time if their symptoms worsen or if they face any complications. During the study, participants will complete tests such as the 24-hour pad-weight test to measure incontinence severity and patient questionnaires about their improvement. Researchers will follow patients for up to 5 years to assess treatment outcomes and safety. The total participation time varies based on follow-up but involves regular monitoring and the opportunity to report issues anytime.
CONDITIONS
Brief Title
Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Male with urinary incontinence due to previous prostate surgery
- First-time implantation of the artificial urinary sphincter
- Willing and able to give informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Short duration before procedure
Participants undergo a standard diagnostic work-up before the artificial sphincter procedure.
Surgery and Immediate Post-operative Care
Duration - Procedure day and immediate recovery period
Participants have the Victo artificial sphincter surgically implanted due to severe urinary incontinence.
Post-operative Follow-up
Duration - Up to 5 years
Participants attend regular visits starting 3 months after device activation and then every 12 months to monitor continence and device function. They may also contact the study center at any time if continence worsens or complications occur.
Regular visits: 1 visit at 3 months post-activation and annual visits thereafter
Trial Site Locations
Total: 1 location
1
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852
Actively Recruiting
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Research Team
J
Jiří Hynčica
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
VICTO and VICTO-plus - novel alternative for the mangement of postprostatectomy incontinence. Early perioperative and postoperative experience.
Peter Weibl, Rudi Hoelzel, Michael Rutkowski...
https://pubmed.ncbi.nlm.nih.gov/30038818Pad weight testing in the evaluation of urinary incontinence.
Jan Krhut, Roman Zachoval, Phillip P Smith...
https://pubmed.ncbi.nlm.nih.gov/23797972