Skip to main content
OpenTrials
Completed

NCT Number: NCT05440981

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iTind device

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 After confirming the position of the device, cystoscopy will be withdrawn and the position will be finished.

Primary outcomes

  1. Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment score

    Time frame: 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 outcomes

  1. 30-day complications after study intervention

    Time frame: at 30 days after study intervention

    The severity of AE is grade by Clavien-Dindo classification.The higher score, the more worse complication

  2. Total score in IPSS questionnaire after study intervention

    Time frame: 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.

  3. International Prostate Symptom Score (IPSS) questionnaire QoL Score

    Time frame: 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

  4. Overactive bladder symptom score (OABSS) questionnaire total score

    Time frame: 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

  5. Pain Score

    Time frame: 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.

  6. Urodynamic function assessed by uroflowmetry parameter

    Time frame: Baseline, 3 months, 6 months and 12 months

    Change in Maximum uroflow, post void residual

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2022
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.