Implanted Nitinol Device (iTind) System in Chinese Males With Lower Urinary Tract Symptom Secondary to BPH
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Conditions
Treatments
Details and patient eligibility
About
This is a prospective series of consecutive cases of patients undergoing iTind for the treatment of male LUTS.
Full description
This is a prospective series of consecutive cases of patients undergoing iTind for the treatment of male LUTS.The procedure was carried out using perioperative antibiotic prophylaxis, according to the local culture and sensitivity profile. Patient will be discharged and readmitted 7 days for device removal under local anaesthesia transurethrally. After the device is removed and patients will be monitor for any problem in voiding or haematuria, and then discharged. Subjects will be follow-up at 3-, 6, 12- months after treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Men aged between 50 - 80 years
- Clinically indicated for surgical treatment
- Prostate volume of 25 to 75 cc
Exclusion criteria
- Patients with active urinary tract infection or in retention of urine
- Patients with bleeding disorder or on anti-coagulation
- Patients with bladder pathology including bladder stone and bladder cancer
- Patients with urethral stricture
- Patients with neurogenic bladder and/or sphincter abnormalities
- Patients with previous nonpharmacological prostate treatment,
- Prostate cancer
- Fail to give informed consent
Trial design
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Chi Fai NG, MD
Data sourced from clinicaltrials.gov
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