Prostate Hyperplasia
Conditions
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.
Interventions
DEVICEiTind 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 After confirming the position of the device, cystoscopy will be withdrawn and the position will be finished.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment score | 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
| Measure | Time frame | Description |
|---|---|---|
| Total score in IPSS questionnaire after study intervention | 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. |
| International Prostate Symptom Score (IPSS) questionnaire QoL Score | 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 |
| 30-day complications after study intervention | at 30 days after study intervention | The severity of AE is grade by Clavien-Dindo classification.The higher score, the more worse complication |
| Pain Score | 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. |
| Urodynamic function assessed by uroflowmetry parameter | Baseline, 3 months, 6 months and 12 months | Change in Maximum uroflow, post void residual |
| Overactive bladder symptom score (OABSS) questionnaire total score | 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 |
Countries
Hong Kong
Outcome results
None listed