NCT02901392

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

Fundación Instituto Valenciano de Oncología Prospective Registry for Patients Undergoing Male Sling or Artificial Urinary Sphincter After Prostatectomy or Radiation Therapy for Prostate Cancer.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Fundación Instituto Valenciano de Oncología · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. 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) 2. Description of surgical technique 3. 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) 4. 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.

Conditions

• Urinary Incontinence, Stress

Interventions

Type	Name	Description
PROCEDURE	AMS-800	Artificial urianry sphincter
PROCEDURE	ADVANCE/ADVANCEXP	Male sling
PROCEDURE	VIRTUE	Male sling
PROCEDURE	INVANCE	Male sling

Timeline

• Start date: 2004-04-01
• Primary completion: 2019-04-01
• Completion: 2031-04-01
• First posted: 2016-09-15
• Last updated: 2018-08-02

Locations

1 site across 1 country: Spain