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

Recruiting now

Conditions studied: Urinary Incontinence, Stress

In brief

Stress urinary incontinence is a significant potential source of morbidity after radical prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary sphincter remains the preferred therapeutic option. However, this technique is not free from complications. In an attempt to avoid such complications, male sling has been suggested for use in patients with mild degrees of stress incontinence.

Key facts

Study ID

NCT02901392

Run by

Fundación Instituto Valenciano de Oncología

People needed

400

Starts

2004-04-01

Expected to finish

2031-04-01

Last updated by the study team

2018-08-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Argimiro Collado — Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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