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

Urinary Incontinence, Stress Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02901392
Study type Observational [Patient Registry]
Source Fundación Instituto Valenciano de Oncología
Contact Argimiro Collado, MD, PhD
Phone 0034961114030
Email argicollado@gmail.com
Status Recruiting
Phase
Start date April 2004
Completion date April 2031
View Details
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