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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02901392 |
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Date of registration:
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12/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fundación IVO Registry for Patients Undergoing Sling or Artificial Urinary Sphincter After Prostate Cancer Treatment
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Scientific title:
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Fundación Instituto Valenciano de Oncología Prospective Registry for Patients Undergoing Male Sling or Artificial Urinary Sphincter After Prostatectomy or Radiation Therapy for Prostate Cancer. |
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Date of first enrolment:
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April 2004 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02901392 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Argimiro Collado, MD, PhD |
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Address:
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Telephone:
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0034961114030 |
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Email:
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argicollado@gmail.com |
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Affiliation:
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Name:
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Argimiro Collado, MD,PhD |
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Address:
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Telephone:
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0034961114030 |
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Email:
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Affiliation:
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Name:
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Argimiro Collado, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundación IVO |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Urinary Incontinence, Stress
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Intervention(s)
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Procedure: AMS-800
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Procedure: INVANCE
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Procedure: VIRTUE
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Procedure: ADVANCE/ADVANCEXP
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Primary Outcome(s)
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Success rate
[Time Frame: 3 months]
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Secondary Outcome(s)
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Quality of Life in patients with male surgery incontinence
[Time Frame: 15 years]
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Lower tract urinary symptoms modification after male surgery incontinence
[Time Frame: 15 years]
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Continence improvement
[Time Frame: 15 years]
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Secondary ID(s)
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Oncodinamia01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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