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

This trial does not accept healthy volunteers

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 population

Patients with stress urianry incontinence undergoing male sling or artificial urinary sphincter after prostatectomy or radiation therapy for prostate cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • AMS-800

    Procedure/Surgery

    Artificial urianry sphincter

  • ADVANCE/ADVANCEXP

    Procedure/Surgery

    Male sling

  • VIRTUE

    Procedure/Surgery

    Male sling

  • INVANCE

    Procedure/Surgery

    Male sling

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Artificial urinary sphincter AMS-800®1 intervention
Group B: AdVance/AdvanceXP®1 intervention
Group C: VIRTUE®1 intervention
Group D: INVANCE®1 intervention

Trial outcomes

Primary outcomes

1

Success rate

Cure is defined as no pad use

Time frame
3 months

Secondary outcomes

1

Continence improvement

Assessed by means of the 24-Hour Pad Weight test

Time frame
15 years
2

Lower tract urinary symptoms modification after male surgery incontinence

Assessed with IPSS questionaires

Time frame
15 years
3

Quality of Life in patients with male surgery incontinence

Assessed with "International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)" questionaires

Time frame
15 years

Other outcomes

Sponsors and contacts

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