An interventional study of iTind device in Prostate Hyperplasia, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
This is a prospective series of consecutive cases of patients undergoing iTind for the treatment of male LUTS.
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 15 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
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 After confirming the position of the device, cystoscopy will be withdrawn and the position will be finished.
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.
Time frame: Baseline and 6 months
30-day complications after study intervention
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
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Immediately after study intervention and 1 wee after study intervention
Urodynamic function assessed by uroflowmetry parameter
Change in Maximum uroflow, post void residual
Time frame: Baseline, 3 months, 6 months and 12 months
Plan to share: No
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Chinese University of Hong Kong