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

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ClinicalTrials.gov Identifier: NCT02901392
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Fundación Instituto Valenciano de Oncología

Brief 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.

Condition or disease Intervention/treatment
Urinary Incontinence, Stress Procedure: AMS-800 Procedure: ADVANCE/ADVANCEXP Procedure: VIRTUE Procedure: INVANCE

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
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.
Study Start Date : April 2004
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2031

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Success rate [ Time Frame: 3 months ]
    Cure is defined as no pad use


Secondary Outcome Measures :
  1. Continence improvement [ Time Frame: 15 years ]
    Assessed by means of the 24-Hour Pad Weight test

  2. Lower tract urinary symptoms modification after male surgery incontinence [ Time Frame: 15 years ]
    Assessed with IPSS questionaires

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901392


Contacts
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Contact: Argimiro Collado, MD, PhD 0034961114030 ext 4030 argicollado@gmail.com

Locations
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Spain
Argimiro Collado Recruiting
Valencia, Spain, 46009
Contact: Argimiro Collado, MD,PhD    0034961114030      
Sponsors and Collaborators
Fundación Instituto Valenciano de Oncología
Investigators
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Principal Investigator: Argimiro Collado, MD,PhD Fundación IVO

Additional Information:

Publications of Results:
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Responsible Party: Fundación Instituto Valenciano de Oncología
ClinicalTrials.gov Identifier: NCT02901392     History of Changes
Other Study ID Numbers: Oncodinamia01
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fundación Instituto Valenciano de Oncología:
Male Urethral Slings
Artificial Urinary Sphincter
Prostatectomy
Radiotherapy
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms