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

Chinese University of Hong Kong13 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Hyperplasia

Interventions

iTind deviceDEVICE

Cystoscopy will be performed to assess the anatomy of the bladder and prostate. The iTind device would be inserted under visual guidance into the bladder. The device will then be deployed and under visual guidance, it will be positioned at the prostatic lumen. After confirming the position of the device, cystoscopy will be withdrawn and the position will be finished.

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment score

Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires.The higher score the more worse symptom.

Time frame: Baseline and 6 months

Secondary Outcomes

30-day complications after study intervention

The severity of AE is grade by Clavien-Dindo classification.The higher score, the more worse complication

Time frame: at 30 days after study intervention

Total score in IPSS questionnaire after study intervention

International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score the more worse symptom.

Time frame: Baseline, 3 months, 6 months and 12 months

International Prostate Symptom Score (IPSS) questionnaire QoL Score

Change in quality of life assessed by International Prostate Symptom Score questionnaire (ranges from 0 to 6). The lower score the more worse QoL

Time frame: Baseline, 3 months, 6 months and 12 months

Overactive bladder symptom score (OABSS) questionnaire total score

Change in total score in Overactive Bladder Symptom Score questionnaire (ranges from 0 - 15). The higher score the more worse symptom

Time frame: Baseline, 3 months, 6 months and 12 months

Pain Score

Post-treatment pain score ranges from 1 to 10. The higher score the more pain.

Time frame: Immediately after study intervention and 1 wee after study intervention

Urodynamic function assessed by uroflowmetry parameter

Data from ClinicalTrials.gov

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