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

Prostate Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440981
• Other study ID #: CRE-2022.244
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Chi Fai NG, MD
• Phone: 35051663
• Email: ngcf[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostate Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Urodynamic function assessed by uroflowmetry parameter	Change in Maximum uroflow, post void residual	Baseline, 3 months, 6 months and 12 months