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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02267-38 | Other Identifier | ID-RCB |
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The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study.
Transurethral resection of the prostate, laser vaporization or enucleation, and simple open prostatectomy represent the current gold standard surgical interventions for BPH-related obstruction. However, these treatments are burdened by their invasiveness, intra and post-operative morbidity, and long-term complications, including ejaculatory dysfunction (70%), urethral strictures (7%), urinary incontinence (2%), and bleeding. Laser-based surgical strategies have only partially overcome these drawbacks.
To provide a personalized therapy for the treatment of BPH related-symptoms, several minimally invasive surgical therapies (MISTs) were developed with the aim of achieving outcomes comparable to the gold standard invasive procedures while minimizing SD and other complications. Urolift implants and Rezum system have demonstrated less complication rate and hospitalization time than standard surgeries.
Recently, 3D ultrasound-guided transperineal focal microwave ablation (TMA) was developed as a focal treatment for localized prostate cancer. Ultrasound-MRI image fusion was performed with organ-based tracking-registration using KOELIS Trinityâ„¢ (Koelis, Meylan, France). Microwave thermal ablation was provided by the TATO generator (Biomedical Srl, Firenze, Italy) using a single 17G needle inserted transperineally. This treatment was reported to be safe, precise, and feasible in an outpatient setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with BPH | Experimental | Targeted Microwave Ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted Microwave Ablation | Procedure | 3D ultrasound-guided focal thermal ablation of the prostate transition zone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between IPSS score at baseline and at 3 months | The International Prostate Symptom Score IPSS is a self-questionnaire - It contains seven questions about symptoms related to BPH and one question about the patient's perceived quality of life. The seven questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35): 0-7 Mildly symptomatic - 8-19 Moderately symptomatic - 20-35 Severely symptomatic - Efficacy of the intervention with a decrease of at least 6 points on IPSS score between 3 months and baseline. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | 1 month | |
| Need for postoperative bladder catheterization | 1 month | |
| Duration of postoperative bladder catheterization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas BARRY DELONGCHAMPS, MD, PHD | Contact | +33 1 58 41 27 64 | nicolas.barry-delongchamps@aphp.fr | |
| Karima MESBAHI | Contact | +33 1 58 41 12 11 | karima.mesbahi@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas BARRY DELONGCHAMPS, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Recruiting | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26166130 | Background | Yuan JQ, Mao C, Wong SY, Yang ZY, Fu XH, Dai XY, Tang JL. Comparative Effectiveness and Safety of Monodrug Therapies for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Network Meta-analysis. Medicine (Baltimore). 2015 Jul;94(27):e974. doi: 10.1097/MD.0000000000000974. | |
| 24972732 | Background |
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Targeted Microwave Ablation
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| 1 month |
| Postoperative pain | Visual analogue scale (1 to 10) | two hours after surgery |
| Dimensions of transitional zone tissue ablation | Measurement on prostatic mpMRI performed at day 7 | 7 days |
| Male Sexual Health Questionnaire-ejaculatory dysfunction Short Form (MSHQ-EjD-SF) | 4 items to assess ejaculatory functions This score is based on 3 questions concerning symptoms (score from 1 to 15) and one question about discomfort (score from 0 to 5). | 1, 3 and 12 months |
| International Index of Erectile Function (IIEF-15) | 15 items to assess ejaculatory functions and global sexual life - This score is based on 3 questions concerning symptoms (score from 1 to 15) and one question about discomfort (score from 0 to 5). | 1, 3 and 12 months |
| IPSS score | to assess urinary tract symptoms - 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic | 1, 3 and 12 months |
| Urinary Symptom Profile (USP) | to assess urinary tract symptoms | 1, 3 and 12 months |
| Qmax | to assess urinary tract symptoms | 1, 3 and 12 months |
| Patients perspectives and treatment preferences | Characterization of patient motivation to undergo TMA at baseline, as assessed by the patient perspective questionnaire | Baseline |
| Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25. |
| 26614889 | Background | McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22. |
| 23541338 | Background | Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N'dow J, Nordling J, de la Rosette JJ; European Association of Urology. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2013 Jul;64(1):118-40. doi: 10.1016/j.eururo.2013.03.004. Epub 2013 Mar 13. |
| 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. |
| 31619035 | Background | Leonardo C, Lombardo R, Cindolo L, Antonelli A, Greco F, Porreca A, Veneziano D, Pastore A, Dalpiaz O, Ceruti C, Verze P, Borghesi M, Schiavina R, Falabella R, Minervini A; AGILE Group. What is the standard surgical approach to large volume BPE? Systematic review of existing randomized clinical trials. Minerva Urol Nefrol. 2020 Feb;72(1):22-29. doi: 10.23736/S0393-2249.19.03589-6. Epub 2019 Oct 10. |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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