Using an adjustable artificial sphincter to treat male incontinence after prostate surgery
Clinical Outcomes of the Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery - Prospective Follow-up Study
This study is testing whether an adjustable artificial sphincter can help men who have urinary incontinence after prostate surgery feel more comfortable and regain control.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Trial ID | NCT06239909 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of the Victo adjustable artificial sphincter in male patients suffering from urinary incontinence following prostate surgery. Participants will undergo a standard diagnostic work-up before the device is implanted, and they will have regular follow-up visits at 3 months and annually thereafter. The study will assess changes in urinary incontinence through various tests and questionnaires, allowing for adjustments to the device as needed. Statistical analyses will be performed to determine the significance of the results.
Who should consider this trial
Good fit: Ideal candidates are male patients who have urinary incontinence due to previous prostate surgery and are willing to provide informed consent.
Not a fit: Patients who do not have urinary incontinence resulting from prostate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for men experiencing incontinence after prostate surgery.
How similar studies have performed: Other studies have shown success with similar artificial sphincter approaches, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * urinary incontinence due to previous prostate surgery * primo-implantation of the artificial urinary sphincter * subject willing and able to give informed consent Exclusion Criteria: \- none
Where this trial is running
Ostrava, Moravian-Silesian Region
- University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (Recruiting)
Study contacts
- Principal investigator: Jan Krhut, prof.,MD, PhD — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.