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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporarily implanted nitinol device (iTind) group | Experimental | Subjects will undergo iTind for the treatment of male LUTS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 After confirming the position of the device, cystoscopy will be withdrawn and the position will be finished. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day complications after study intervention | The severity of AE is grade by Clavien-Dindo classification.The higher score, the more worse complication | at 30 days after study intervention |
| Total score in IPSS questionnaire after study intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi Fai NG, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24445912 | Background | 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. | |
| 25613154 | Background | 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. |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score the more worse symptom.
| 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 | 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 | 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. | Immediately after study intervention and 1 wee after study intervention |
| Urodynamic function assessed by uroflowmetry parameter | Change in Maximum uroflow, post void residual | Baseline, 3 months, 6 months and 12 months |
| 33005003 | Background | 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. |
| 33373708 | Background | 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. |
| D052801 |
| Male Urogenital Diseases |