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

Primary Purpose

Prostate Hyperplasia

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
iTind device
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Hyperplasia

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temporarily implanted nitinol device (iTind) group

Arm Description

Subjects will undergo iTind for the treatment of male LUTS.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

30-day complications 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
International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score the more worse symptom.
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
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
Pain Score
Post-treatment pain score ranges from 1 to 10. The higher score the more pain.
Urodynamic function assessed by uroflowmetry parameter
Change in Maximum uroflow, post void residual

Full Information

First Posted
June 27, 2022
Last Updated
May 31, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05440981
Brief Title
Implanted Nitinol Device (iTind) System in Chinese Males With Lower Urinary Tract Symptom Secondary to BPH
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temporarily implanted nitinol device (iTind) group
Arm Type
Experimental
Arm Description
Subjects will undergo iTind for the treatment of male LUTS.
Intervention Type
Device
Intervention Name(s)
iTind device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment score
Description
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 Outcome Measure Information:
Title
30-day complications after study intervention
Description
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
Title
Total score in IPSS questionnaire after study intervention
Description
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
Title
International Prostate Symptom Score (IPSS) questionnaire QoL Score
Description
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
Title
Overactive bladder symptom score (OABSS) questionnaire total score
Description
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
Title
Pain Score
Description
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
Title
Urodynamic function assessed by uroflowmetry parameter
Description
Change in Maximum uroflow, post void residual
Time Frame
Baseline, 3 months, 6 months and 12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Fai NG, MD
Phone
35051663
Email
ngcf@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Fai NG, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Fai NG, MD
Phone
35052625
Email
ngcf@surgery.cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24445912
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.
Results Reference
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PubMed Identifier
25613154
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.
Results Reference
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PubMed Identifier
33005003
Citation
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.
Results Reference
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PubMed Identifier
33373708
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.
Results Reference
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Implanted Nitinol Device (iTind) System in Chinese Males With Lower Urinary Tract Symptom Secondary to BPH

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