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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorFundación Instituto Valenciano de Oncología

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • AMS-800
  • ADVANCE/ADVANCEXP
  • VIRTUE
  • INVANCE

Treatment groups

400 Participants
are divided into 4 treatment groups