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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Hyperplasia
• Intervention / Treatment: Device: iTind device

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chi Fai NG, MD; Phone Number: 35051663; Email: ngcf@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince Of Wales Hospital
    • Contact: Chi Fai NG, MD; Phone Number: 35052625; Email: ngcf@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Temporarily implanted nitinol device (iTind) group; Subjects will undergo iTind for the treatment of male LUTS.	Device: iTind device; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Publications and helpful links

General Publications

• Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
• Amparore D, Fiori C, Valerio M, Schulman C, Giannakis I, De Cillis S, Kadner G, Porpiglia F. 3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):349-357. doi: 10.1038/s41391-020-00281-5. Epub 2020 Oct 1.
• Chughtai B, Elterman D, Shore N, Gittleman M, Motola J, Pike S, Hermann C, Terrens W, Kohan A, Gonzalez RR, Katz A, Schiff J, Goldfischer E, Grunberger I, Tu LM, Alshak MN, Kaminetzky J. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial. Urology. 2021 Jul;153:270-276. doi: 10.1016/j.urology.2020.12.022. Epub 2020 Dec 26.
• Kahokehr A, Gilling PJ. Landmarks in BPH--from aetiology to medical and surgical management. Nat Rev Urol. 2014 Feb;11(2):118-22. doi: 10.1038/nrurol.2013.318. Epub 2014 Jan 21.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: CRE-2022.244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No