[Which patients with stress urinary incontinence after radical prostatectomy benefit from the indication of an Invance?].
Argimiro Collado, Alvaro Gómez-Ferrer, José Rubio-Briones...
https://pubmed.ncbi.nlm.nih.gov/20065535Actively Recruiting
Age: 18Years +
MALE
ID02901392
Fundación Instituto Valenciano de Oncología Prospective Registry for Patients Undergoing Male Sling or Artificial Urinary Sphincter After Prostatectomy or Radiation Therapy for Prostate Cancer
Led by Fundación Instituto Valenciano de Oncología · Updated on 2018-08-02
400
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Stress urinary incontinence can occur after treatments like prostatectomy or radiation therapy for prostate cancer and may cause significant problems. This research is observing men who experience this condition to learn more about treatments using male slings or artificial urinary sphincters. Currently, artificial urinary sphincters are a common treatment, but they can have complications, so male slings have been suggested for milder cases as an alternative. The study follows male patients treated with one of four devices: the AMS-800 artificial urinary sphincter or one of the male slings—AdVance/AdvanceXP, VIRTUE, or INVANCE. The research collects detailed information before surgery, including bladder tests and clinical parameters, and describes the surgical techniques used. Continence is evaluated three months after surgery to avoid effects from initial swelling, and long-term outcomes like effectiveness and complications are tracked. Participants undergo regular follow-up visits with tests such as the 24-hour pad weight test and a urinary incontinence questionnaire every three months during the first year and every six months thereafter. Researchers monitor continence success, symptom changes, and quality of life over up to 15 years. This careful follow-up helps assess how well the treatments work and any late complications that may develop.
CONDITIONS
Brief Title
Fundación IVO Registry for Patients Undergoing Sling or Artificial Urinary Sphincter After Prostate Cancer Treatment
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- The subject has agreed to be treated with male incontinence surgery devices
- The subject is willing and able to give valid informed consent
- The subject is 18 years of age or older
- The subject has confirmed stress urinary incontinence for at least 12 months after prostatectomy or radiotherapy
- Stress urinary incontinence has been confirmed with a 24-hour pad weight test
- Pre-operative urodynamic assessment and flexible cystoscopy were performed
- The subject can return for follow-up evaluations and complete questionnaires as required by the study
- The subject has no surgical contraindications
You will not qualify if you...
- The subject has an active urinary tract infection or active skin infection near the surgery area
- The subject has serious bleeding disorders
- The subject has unstable bladder neck stricture disease
- The subject has a neurogenic bladder condition not treatable by medication or other methods
- The subject has detrusor-external sphincter dyssynergia
- The subject is unable or unwilling to sign informed consent or comply with follow-up requirements
- The subject is likely to undergo radiation therapy within the next 6 months
- The subject has a history of connective tissue or autoimmune conditions
- The subject has a compromised immune system
- The subject has renal insufficiency or urinary tract obstruction
- The subject's reading level is inadequate for understanding study materials and questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Single day for surgery plus immediate recovery
Participants undergo male incontinence surgery using a sling or artificial urinary sphincter device.
1 surgical visit and immediate post-operative care
Post-operative Follow-up
Duration - 3 months to several years
Participants are evaluated for continence and functional outcomes, including 24h-Pad Weight test and questionnaires.
Visits every 3 months for the first year, then every 6 months thereafter
Trial Site Locations
Total: 1 location
1
Argimiro Collado
Valencia, Spain, 46009
Actively Recruiting
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Research Team
A
Argimiro Collado, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
AdVance/AdVance XP transobturator male slings: preoperative degree of incontinence as predictor of surgical outcome.
Argimiro Collado Serra, Luís Resel Folkersma, José L Domínguez-Escrig...
https://pubmed.ncbi.nlm.nih.gov/23465151Prospective follow-up study of artificial urinary sphincter placement preserving the bulbospongiosus muscle.
Argimiro Collado Serra, José Domínguez-Escrig, Álvaro Gómez-Ferrer...
https://pubmed.ncbi.nlm.nih.gov/27654121Functional follow-up after Advance® and Advance XP® male sling surgery: assessment of predictive factors.
Argimiro Collado, José Domínguez-Escrig, Isabel María Ortiz Rodríguez...
https://pubmed.ncbi.nlm.nih.gov/29948042