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

Not Applicable

Recruiting

• Conditions: Prostate Hyperplasia
• Interventions: Device: iTind device

• Registration Number: NCT05440981
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-01
• Study Start: 2022-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Men aged between 50 - 80 years
• Clinically indicated for surgical treatment
• Prostate volume of 25 to 75 cc

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temporarily implanted nitinol device (iTind) group	iTind device	Subjects will undergo iTind for the treatment of male LUTS.

Primary Outcome Measures

Name	Time	Method
Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment score	Baseline and 6 months	Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires.The higher score the more worse symptom.

Secondary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS) questionnaire QoL Score	Baseline, 3 months, 6 months and 12 months	Change in quality of life assessed by International Prostate Symptom Score questionnaire (ranges from 0 to 6). The lower score the more worse QoL
30-day complications after study intervention	at 30 days after study intervention	The severity of AE is grade by Clavien-Dindo classification.The higher score, the more worse complication
Total score in IPSS questionnaire after study intervention	Baseline, 3 months, 6 months and 12 months	International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score the more worse symptom.
Overactive bladder symptom score (OABSS) questionnaire total score	Baseline, 3 months, 6 months and 12 months	Change in total score in Overactive Bladder Symptom Score questionnaire (ranges from 0 - 15). The higher score the more worse symptom
Pain Score	Immediately after study intervention and 1 wee after study intervention	Post-treatment pain score ranges from 1 to 10. The higher score the more pain.
Urodynamic function assessed by uroflowmetry parameter	Baseline, 3 months, 6 months and 12 months	Change in Maximum uroflow, post void residual

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong