Registry for patients with urinary incontinence after prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Argimiro Collado
  Valencia, Spain Recruiting

Study contacts

• Principal investigator: Argimiro Collado, MD,PhD — Fundación IVO
• Study coordinator: Argimiro Collado, MD, PhD
• Email: argicollado@gmail.com
• Phone: 0034961114030

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.