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

The Use of Temporarily Implanted Nitinol Device (iTind) System in Chinese Male Patients With Lower Urinary Tract Symptom Secondary to Benign Prostate Enlargement

NCT05440981•Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

This is a prospective series of consecutive cases of patients undergoing iTind for the treatment of male LUTS.

Detailed 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.

Eligibility

Age

50 - 80 years

Sex

MALE

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

Locations (1)

Prince of Wales Hospital

Shatin, Hong Kong

Key Dates

Start Date

September 1, 2022

Primary Completion Date

January 15, 2025

Completion Date

January 21, 2025

Last Updated

May 6, 2025

Enrollment

ACTUAL participants

Conditions

Prostate Hyperplasia

Interventions

iTind device

DEVICE

Prostate Metabolism, Cancer Risk and Gut Microbiota

NCT06116851

Prostate CancerProstate Hyperplasia

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COMPLETEDPHASE4

Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate)

NCT01747577

Overactive BladderBenign Prostate Hyperplasia+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Prostate Metabolism, Cancer Risk and Gut Microbiota

Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate)

Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Symptomatic Benign Prostatic Hyperplasia

Standardization of Prostatic Resection by Virtual Computational Reconstruction and Computational Flow Dynamics

MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)

Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)