Fundación IVO Registry for Patients Undergoing Sling or Artificial Urinary Sphincter After Prostate Cancer Treatment

This is a prospective collection of pre-defined parameters on the treatment of male stress urinary incontinence by male sling or artificial urinary sphincter.

This registry includes:

• Pre-operative urodynamic assessment, cystoscopy and other preoperative clinical parameters (i.e. age, body mass index, bladder neck contracture treated, urgency, 24h-PW, cystometry and pressure/flow, repositioning test)
• Description of surgical technique
• Continence is evaluated 3 months after surgery, avoiding the potential confounding impact of the initial tissue edema (Cure was defined as no pad use, and all other cases were defined as failures)
• Evaluation of long term functional outcome (efficacy, late complications and the loss of continence)

Surgery is performed with:

Device: Virtue® Device: Advance® and AdvanceXP® Device: Artificial urinary sphincter AMS-800® Device: Invance® Male Incontinence Sling

A prospective functional follow-up, with 24h-Pad Weight test and ICIQ-UI SF, is carried out 3-monthly for the first year and 6-monthly thereafter, parallel to the oncological follow-up.

Inclusion criteria

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

Exclusion criteria

• The subject has an active urinary tract infection or active skin infection in region of surgery
• The subject has serious bleeding disorders
• The subject has unstable bladder neck stricture disease
• The subject has Neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
• The subject has Detrusor-external sphincter dyssynergia.
• 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
• The subject is likely to undergo radiation therapy within the next 6 months
• The subject has a history of connective tissue or autoimmune conditions.
• The subject has a compromised immune system.
• The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
• The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials