Prostate Hyperplasia Clinical Trial
Official title:
The Use of Temporarily Implanted Nitinol Device (iTind) System in Chinese Male Patients With Lower Urinary Tract Symptom Secondary to Benign Prostate Enlargement
This is a prospective series of consecutive cases of patients undergoing iTind for the treatment of male LUTS.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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. | Baseline, 3 months, 6 months and 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Urodynamic function assessed by uroflowmetry parameter | Change in Maximum uroflow, post void residual | Baseline, 3 months, 6 months and 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05443451 -
BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY
|
N/A | |
Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
Not yet recruiting |
NCT05017285 -
Ejaculation Preservation After Laser Enucleation Prostate
|
N/A | |
Completed |
NCT02778243 -
Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level
|
N/A | |
Completed |
NCT04212403 -
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)
|
N/A | |
Recruiting |
NCT05531240 -
Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)
|
N/A | |
Recruiting |
NCT03176017 -
Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP
|
N/A | |
Completed |
NCT02244294 -
FLOMAX® Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia (BPH)
|
Phase 2 | |
Recruiting |
NCT03966950 -
Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia
|
N/A | |
Enrolling by invitation |
NCT06469125 -
Anatomic Endoscopic Prostate Enucleation and BICEP Classification
|
||
Recruiting |
NCT06116851 -
Prostate Metabolism, Cancer Risk and Gut Microbiota
|
||
Completed |
NCT04781985 -
Prostatic Resection Cavity Stone Post Transurethral Resection of the Prostate (TURP). A Rare Case Scenario
|
N/A | |
Not yet recruiting |
NCT01876836 -
Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications
|
Phase 4 | |
Completed |
NCT05941260 -
Standardization of Prostatic Resection by Virtual Computational Reconstruction and Computational Flow Dynamics
|
||
Completed |
NCT04580628 -
Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)
|
||
Completed |
NCT04848181 -
The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate
|
Early Phase 1 | |
Recruiting |
NCT06224218 -
Prostate Single Port & Laser Enucleation Comparison Trial
|
N/A | |
Completed |
NCT04781049 -
Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial
|
N/A | |
Completed |
NCT05059431 -
The Effect of Human Prostate Tissue on Platelet Activation
|
||
Completed |
NCT05108662 -
Inflammatory Markers: HOLEP Versus TURP
|
N/A |