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
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Argimiro Collado
RECRUITING
Valencia
Contact Information
Primary
Argimiro Collado, MD, PhD
argicollado@gmail.com
0034961114030
Time Frame
Start Date: 2004-04
Estimated Completion Date: 2031-04
Participants
Target number of participants: 400
Treatments
Artificial urinary sphincter AMS-800®
Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AMS-800®
AdVance/AdvanceXP®
Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AdVance/AdvanceXP®
VIRTUE®
Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with VIRTUE®
INVANCE®
Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with INVANCE®
Sponsors
Leads: Fundación Instituto Valenciano de Oncología

This content was sourced from clinicaltrials.gov

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