Registry for patients with urinary incontinence after prostate cancer treatment

Fundación Instituto Valenciano de Oncología Prospective Registry for Patients Undergoing Male Sling or Artificial Urinary Sphincter After Prostatectomy or Radiation Therapy for Prostate Cancer.

This study collects information from men who have urinary incontinence after prostate cancer treatment to see how well different surgical options work and what problems they might cause over time.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Fundación Instituto Valenciano de Oncología (other)
• Drugs / interventions: radiation
• Locations: 1 site (Valencia)
• Trial ID: NCT02901392 on ClinicalTrials.gov

What this trial studies

This observational registry collects data on male patients experiencing stress urinary incontinence following prostate cancer treatment, specifically those undergoing surgery with male slings or artificial urinary sphincters. It includes pre-operative assessments, surgical technique descriptions, and evaluations of continence and long-term outcomes. The study aims to understand the efficacy and complications associated with these surgical interventions over time. Patients will be followed up regularly to monitor their functional outcomes and any late complications.

Who should consider this trial

Good fit: Ideal candidates are men over 18 who have stress urinary incontinence for at least 12 months following prostatectomy or radiotherapy.

Not a fit: Patients with active urinary tract infections, serious bleeding disorders, or neurogenic bladder conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could improve treatment strategies for urinary incontinence in men after prostate cancer, leading to better patient outcomes.

How similar studies have performed: Similar studies have shown success in evaluating surgical interventions for urinary incontinence, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

1. The subject has agreed to be treated with the male Incontinence surgery devices
2. The subject is willing and able to give valid informed consent.
3. The subject is \> 18 years of age.
4. The subject has confirmed stress urinary incontinence for at least 12 months after prostatectomy or radiotherapy.
5. It has been confirmed the stress urinary incontinence with 24-Hour Pad Weight test
6. Pre-operative urodynamic assessment and flexible cystoscopy were performed in all cases
7. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
8. There are no surgical contraindications.

Exclusion Criteria:

1. The subject has an active urinary tract infection or active skin infection in region of surgery
2. The subject has serious bleeding disorders
3. The subject has unstable bladder neck stricture disease
4. The subject has Neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
5. The subject has Detrusor-external sphincter dyssynergia.
6. The subject is unable or unwilling to sign the informed consent form (ICF)and/or comply with all follow-up requirements according to the study protocol
7. The subject is likely to undergo radiation therapy within the next 6 months
8. The subject has a history of connective tissue or autoimmune conditions.
9. The subject has a compromised immune system.
10. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
11. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials

Where this trial is running

Valencia

• Argimiro Collado — Valencia, Spain (RECRUITING)

Study contacts

• Principal investigator: Argimiro Collado, MD,PhD — Fundación IVO
• Study coordinator: Argimiro Collado, MD, PhD

Conditions: Urinary Incontinence, Stress, Male Urethral Slings, Artificial Urinary Sphincter, Prostatectomy, Radiotherapy