Implanted Nitinol Device (iTind) System in Chinese Males With Lower Urinary Tract Symptom Secondary to BPH

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The Chinese University of Hong Kong

Status

Enrolling

Conditions

Prostate Hyperplasia

Treatments

Device: iTind device

Study type

Interventional

Funder types

Other

Identifiers

NCT05440981
CRE-2022.244

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

15 estimated patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy 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

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Temporarily implanted nitinol device (iTind) group
Experimental group
Description:
Subjects will undergo iTind for the treatment of male LUTS.
Treatment:
Device: iTind device

Trial contacts and locations

0

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Central trial contact

Chi Fai NG, MD

Data sourced from clinicaltrials.gov

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