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

July 31, 2018 updated by: Fundación Instituto Valenciano de Oncología

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valencia, Spain, 46009
        • Recruiting
        • Argimiro Collado
        • Contact:
          • Argimiro Collado, MD,PhD
          • Phone Number: 0034961114030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. The subject has agreed to be treated with the male Incontinence surgery devices
  2. The subject is willing and able to give valid informed consent.
  3. The subject is > 18 years of age.
  4. The subject has confirmed stress urinary incontinence for at least 12 months after prostatectomy or radiotherapy.
  5. It has been confirmed the stress urinary incontinence with 24-Hour Pad Weight test
  6. Pre-operative urodynamic assessment and flexible cystoscopy were performed in all cases
  7. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
  8. There are no surgical contraindications.

Exclusion Criteria:

  1. The subject has an active urinary tract infection or active skin infection in region of surgery
  2. The subject has serious bleeding disorders
  3. The subject has unstable bladder neck stricture disease
  4. The subject has Neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
  5. The subject has Detrusor-external sphincter dyssynergia.
  6. The subject is unable or unwilling to sign the informed consent form (ICF)and/or comply with all follow-up requirements according to the study protocol
  7. The subject is likely to undergo radiation therapy within the next 6 months
  8. The subject has a history of connective tissue or autoimmune conditions.
  9. The subject has a compromised immune system.
  10. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
  11. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Artificial urinary sphincter AMS-800®
Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AMS-800®
Procedure: AMS-800
Artificial urianry sphincter
AdVance/AdvanceXP®
Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AdVance/AdvanceXP®
Procedure: ADVANCE/ADVANCEXP
Male sling
VIRTUE®
Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with VIRTUE®
Procedure: VIRTUE
Male sling
INVANCE®
Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with INVANCE®
Procedure: INVANCE
Male sling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 3 months
Cure is defined as no pad use
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continence improvement
Time Frame: 15 years
Assessed by means of the 24-Hour Pad Weight test
15 years
Lower tract urinary symptoms modification after male surgery incontinence
Time Frame: 15 years
Assessed with IPSS questionaires
15 years
Quality of Life in patients with male surgery incontinence
Time Frame: 15 years
Assessed with "International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)" questionaires
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Instituto Valenciano de Oncología

Investigators

  • Principal Investigator: Argimiro Collado, MD,PhD, Fundación IVO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

April 1, 2031

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (ESTIMATE)

September 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oncodinamia01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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