NCT02901392Recruiting
Fundación IVO Registry for Patients Undergoing Sling or Artificial Urinary Sphincter After Prostate Cancer Treatment
Fundación Instituto Valenciano de Oncología Prospective Registry for Patients Undergoing Male Sling or Artificial Urinary Sphincter After Prostatectomy or Radiation Therapy for Prostate Cancer.
Source: ClinicalTrials.gov · Last updated 2 Aug 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 12 Sept 2016
- Start date
- Apr 2004
- Primary completion date
- Apr 2019
- Lead sponsor
- Fundación Instituto Valenciano de Oncología
- Diseases
- Prostate cancer
- NCT number
- NCT02901392
What you commit to
- Study type: Observational
- Planned participants: 400
- From Apr 2004 to the primary completion date, Apr 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The subject is likely to undergo radiation therapy within the next 6 months
Other illness
- The subject has an active urinary tract infection or active skin infection in region of surgery
- The subject has serious bleeding disorders
- The subject has unstable bladder neck stricture disease
- The subject has Neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
- The subject has a history of connective tissue or autoimmune conditions.
- The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
Other
- The subject has Detrusor-external sphincter dyssynergia.
- 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
- The subject has a compromised immune system.
- The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Argimiro Collado Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.