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. 2024 Sep 2;25(1):574.
doi: 10.1186/s13063-024-08409-x.

Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial

Anna Kristensen-Alvarez  1   2 , Mikkel Fode  3   4 , Hein Vincent Stroomberg  5   6 , Kurt Krøyer Nielsen  4 , Albert Arch  4 , Lars Birger Lönn  3   7 , Mikkel Taudorf  3   7 , Steven John Widecrantz  8 , Andreas Røder  5   3
Affiliations

Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial

Anna Kristensen-Alvarez et al. Trials. .

Abstract

Background: One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH.

Methods: This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients.

Discussion: In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions.

Trial registration: ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .

Keywords: Benign prostatic hyperplasia; Erectile function; International Prostate Symptom Score; Lower urinary tract symptoms; Minimally invasive surgical therapy; Multicentre; Non-inferiority; Patient-reported outcome measures; Prostatic artery embolisation; Transurethral microwave thermotherapy.

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Conflict of interest statement

HVS: declares financial aid outside of the scope of this manuscript—specifically, travel reimbursement, speaking and lecture fees from MSD Denmark, and project support from Pfizer. AR: declares research grant from Pfizer and MSD for genetic testing of men with prostate cancer. He has also received fees for consulting services and advisory boards for Astellas, MSD, Pfizer, Bayer, Orion, Intuitive, Medtronic, Recordati and Janssen. MF: Speaker for Boston Scientific and Astellas Pharma. MT: Declares financial aid outside of the scope of this manuscript—specifically, consulting services for Neurescue. The remaining authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial profile
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