NCT05440981

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

June 27, 2022

Last Update Submit

May 4, 2025

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 30-day complications after study intervention

    at 30 days after study intervention

  • Total score in IPSS questionnaire after study intervention

    Baseline, 3 months, 6 months and 12 months

  • International Prostate Symptom Score (IPSS) questionnaire QoL Score

    Baseline, 3 months, 6 months and 12 months

  • Overactive bladder symptom score (OABSS) questionnaire total score

    Baseline, 3 months, 6 months and 12 months

  • Pain Score

    Immediately after study intervention and 1 wee after study intervention

  • +1 more secondary outcomes

Study Arms (1)

Temporarily implanted nitinol device (iTind) group

EXPERIMENTAL

Subjects will undergo iTind for the treatment of male LUTS.

Device: iTind device

Interventions

iTind deviceDEVICE

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.

Temporarily implanted nitinol device (iTind) group

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (4)

  • 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.

    PMID: 24445912BACKGROUND

  • 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.

    PMID: 25613154BACKGROUND

  • 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.

    PMID: 33005003BACKGROUND

  • 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.

    PMID: 33373708BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Chi Fai NG, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 1, 2022

Study Start

September 1, 2022

Primary Completion

January 15, 2025

Study Completion

January 21, 2025

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)