Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction

Обзор

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.

Подробное описание

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 Trinity™ (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.

Вмешательства

• Процедура Targeted Microwave Ablation
  3D ultrasound-guided focal thermal ablation of the prostate transition zone

Первичные конечные точки

• Difference between IPSS score at baseline and at 3 months [Срок оценки: 3 months]

Вторичные конечные точки (11)

• Length of hospital stay [Срок оценки: 1 month]
• Need for postoperative bladder catheterization [Срок оценки: 1 month]
• Duration of postoperative bladder catheterization [Срок оценки: 1 month]
• Postoperative pain [Срок оценки: two hours after surgery]
• Dimensions of transitional zone tissue ablation [Срок оценки: 7 days]
• Male Sexual Health Questionnaire-ejaculatory dysfunction Short Form (MSHQ-EjD-SF) [Срок оценки: 1, 3 and 12 months]
• International Index of Erectile Function (IIEF-15) [Срок оценки: 1, 3 and 12 months]
• IPSS score [Срок оценки: 1, 3 and 12 months]
• Urinary Symptom Profile (USP) [Срок оценки: 1, 3 and 12 months]
• Qmax [Срок оценки: 1, 3 and 12 months]
• Patients perspectives and treatment preferences [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Man over 40 years old
• Indication of surgical management for BPH
• Prostate volume ≥30 cc and ≤100 cc as evaluated by ultrasonography
• IPSS score ≥15
• Qmax ≤12 ml/s
• Affiliated to the French national social security system
• Patient suitable for IV sedation or general anesthesia and focal microwave ablation
• Wish and able to comply with planned visits
• Able to express his consent
• Signed informed consent form

Критерии исключения

• Unwillingness to accept the treatment
• Neurological pathology responsible for micturition disorders
• History of prostatic surgery
• History of prostatic arterial embolization
• Prostate protrusion Index of grade 2 (>5 mm) or more as evaluated by ultrasonography.
• Stenosis of the urethra
• History of prostate cancer
• History of radiotherapy or pelvic surgery
• Life expectancy <2 years
• Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks.
• Participation in another clinical study involving an investigational product within 1 month before study entry.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hôpital Cochin — Paris

Публикации

• 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. PMID 26166130
• 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 PMID 24972732
• 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 Hyperplasi PMID 26614889
• 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. PMID 23541338
• 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. PMID 25613154
• 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 PMID 31619035

Идентификаторы

NCT: NCT06212453 · APHP230759 · 2023-A02267-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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