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

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

Detailed Description
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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.

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

Conditions
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Prostate Hyperplasia

Intervention / Treatment
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* Device: iTind device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temporarily implanted nitinol device (iTind) group<br>Subjects will undergo iTind for the treatment of male LUTS. | Device: iTind device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day complications after study intervention | The severity of AE is grade by Clavien-Dindo classification.The higher score, the more worse complication | 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. | 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 | 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 | 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. | Immediately after study intervention and 1 wee after study intervention | 
| Urodynamic function assessed by uroflowmetry parameter | Change in Maximum uroflow, post void residual | Baseline, 3 months, 6 months and 12 months |