Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men with BPH

NCT ID: NCT05686525

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-27
• Study Completion Date: 2030-12-31

Brief Summary

The TUMT-PAE-1 trial is a randomised clinical trial aiming to compare the effectiveness of transurethral microwave thermotherapy (TUMT) with prostatic artery embolisation (PAE) in reducing urinary symptoms caused by prostate gland enlargement. The assessment will be done by patient reported and functional outcome measures. The primary purpose is to evaluate the urinary symptoms six months after the procedure, measured by the International Prostate Symptom Score (IPSS).

Detailed Description

One fourth of men older than 70 years have moderate to severe lower urinary tract symptoms (LUTS) that impair their quality of life (QOL). This is most frequently caused by benign prostatic hyperplasia (BPH). Transurethral resection of the prostate (TURP) is still regarded as the gold standard for surgical treatment of BPH. However, TURP is only an option for patients fit for general anesthesia and can result in complications. Consequently, several less invasive procedures have been developed, as prostatic artery embolization (PAE) and transurethral microwave thermotherapy (TUMT).

The objective of this clinical trial is to assess if transurethral microwave thermotherapy (TUMT) is non-inferior to prostatic artery embolization (PAE) in reducing lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The primary aim is to compare LUTS 6 months after the TUMT and PAE procedures, measured by the International Prostate Symptom Score (IPSS). Both treatments have previously been shown to reduce LUTS with a similar post-procedure outcome in mean IPSS. However, the previous studies differed in baseline characteristics thus it is currently unknown if they perform equally well. Secondary objectives include comparison of patient reported and functional outcomes at short- and long-term follow-up. The trial importantly includes analysis of patient-reported outcome measures of satisfaction with treatment, quality of life, incontinence, erectile and ejaculatory function, as well as evaluation of uroflowmetry, prostate volume, prostate specific antigen, catheter dependency, side effects, hospital admissions and re-treatment rate.

This study is designed as a multi-centre, non-inferiority, open label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments using the randomisation module in REDCap. The primary outcome is expected to be evaluated by a 95% confidence interval against the predefined threshold of +3 points in IPSS for inferiority. Secondary outcomes will be presented descriptively and assessed by students T-test, Chi-squared test and linear mixed models. The patient reported outcomes will be obtained by standardized validated surveys and functional outcomes, side effects and re-treatment rates will be measured at 1 month, 3 months, 6 months, 1 year, 2 years and 5 years post procedure. Assuming a difference in mean IPSS after treatment of 1 point with an standard deviation (SD) of 5 and a non-inferiority margin set at the border for a clinically non-meaningful difference of 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% drop-out the study will include 220 patients. An interim analysis will be performed for every 50 cases.

TUMT and PAE are minimally invasive procedures performed in an outpatient setting that have been shown to reduce LUTS in a similar magnitude. To date there are no randomised clinical trials comparing PAE to TUMT, which is problematic as the most prominent problem with minimally invasive BPH treatment is the lack of proper selection of candidates for a specific procedure. Non-inferiority of TUMT to PAE is expected, with analysis of the secondary outcomes, the investigators aspire to contribute to a better understanding of patient selection for either treatment.

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TUMT

In this arm, patients will undergo Transurethral Microwave Thermotherapy (TUMT) where microwave energy is used to destroy the prostate tissue. TUMT is performed under local anaesthesia. Usually, the patient can be discharged from the hospital on the same day. If the patient cannot be discharged on the same day, he will be admitted to the urological ward. After the treatment, a transurethral catheter is inserted. This will be removed at the physician's discretion when spontaneous voiding is achieved with an acceptable residual volume (in general \<100-150 ml), typically within four weeks.

Group Type: EXPERIMENTAL

Transurethral Microwave Thermotherapy

Intervention Type: PROCEDURE

TUMT is performed by a urologist and/or a trained urological nurse. In TUMT a specially designed instrument that sends out microwave energy is inserted inside the prostate through the urethra. Cooling fluid circulates the instrument to prevent heat from damaging the wall of the urethra. To prevent the temperature from getting too high outside the prostate a temperature sensor is inserted into the patient's rectum and at the penoscrotal angle. If the temperature reaches the safety limit the microwave generator's output will be shut off automatically. Microwave is then used to heat the prostate (preferably to 50-60 degrees Celsius) and destroy hyperplastic prostate tissue. As the prostate heals it will shrink and reduce the blockage of urine flow and the symptoms of BPH.

PAE

In this arm, patients will undergo prostate artery embolisation (PAE) where blocking the blood flow to the prostate causes it to shrink. PAE is performed under local anaesthesia. Usually, the patient can be discharged from the hospital on the same day. If the patient cannot be discharged on the same day, he will be admitted to the urological ward. Patients with a permanent catheter prior to PAE will keep the catheter up to four weeks after the procedure.

Group Type: EXPERIMENTAL

Prostate Artery Embolisation

Intervention Type: PROCEDURE

In PAE an interventional radiologist will insert a small catheter into the vessels that supply blood to the prostate. An arteriogram is done to map the blood vessels feeding the prostate. Tiny embolization particles are injected through the catheter and into the blood vessels to reduce the blood supply to the prostate. This procedure is intended bilaterally at both sides of the prostate. Following the procedure, the prostate will begin to shrink reducing the symptoms of BPH.

Interventions

Transurethral Microwave Thermotherapy

TUMT is performed by a urologist and/or a trained urological nurse. In TUMT a specially designed instrument that sends out microwave energy is inserted inside the prostate through the urethra. Cooling fluid circulates the instrument to prevent heat from damaging the wall of the urethra. To prevent the temperature from getting too high outside the prostate a temperature sensor is inserted into the patient's rectum and at the penoscrotal angle. If the temperature reaches the safety limit the microwave generator's output will be shut off automatically. Microwave is then used to heat the prostate (preferably to 50-60 degrees Celsius) and destroy hyperplastic prostate tissue. As the prostate heals it will shrink and reduce the blockage of urine flow and the symptoms of BPH.

Intervention Type: PROCEDURE

Prostate Artery Embolisation

In PAE an interventional radiologist will insert a small catheter into the vessels that supply blood to the prostate. An arteriogram is done to map the blood vessels feeding the prostate. Tiny embolization particles are injected through the catheter and into the blood vessels to reduce the blood supply to the prostate. This procedure is intended bilaterally at both sides of the prostate. Following the procedure, the prostate will begin to shrink reducing the symptoms of BPH.

Intervention Type: PROCEDURE

Other Intervention Names

TUMT; PAE

Eligibility Criteria

Inclusion Criteria

• Ability to understand and the willingness to sign an informed consent.
• Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment or not patient preference.
• Severe urinary symptoms on IPSS (IPSS score ≥ 20).
• Bladder outlet obstruction (BOO) is defined by Qmax ≤ 15ml/sec, based on uroflowmetry.
• Prostate volume at minimum 50 ml measured by TRUS or MR.
• Men with prostate cancer in Active Surveillance or Watchful Waiting who have LUTS due to a large BPH component are allowed.
• Indwelling catheter or intermittent catheter is allowed. In this case baseline IPSS is 35 points.

Exclusion Criteria

• Active bladder cancer (patients with pTa low-grade tumors are allowed).
• Previous pelvic radiation for cancer treatment.
• Bladder stones (inclusion is allowed after removal).
• Current urethral strictures or bladder neck contracture.
• Neurogenic LUTS.
• Symptomatic urinary tract infection at the time of intervention.
• Documented bacterial prostatitis in the last year.
• Severe atheromatous disease or other pathology preventing catheter-based intervention (as rated on CT angiography by an interventional radiologist).
• Allergy to iodinated contrast media.
• Renal failure defined as estimated glomerular filtration rate (eGFR) < 35ml/min.
• High bleeding risk (spontaneous international normalized ratio (INR) > 1.6).
• Contraindication to conscious sedation (if requested by the patient).
• Prostate median lobe defined by treating physician.
• Urethral colliculus to bladder neck length <35mm.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Herlev and Gentofte Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Anna Kristensen-Alvarez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Røder, Prof.,MD,PhD

Role: STUDY_DIRECTOR

Urological Research Unit, Rigshospitalet

Mikkel M Fode, Prof.,MD,PhD

Role: STUDY_DIRECTOR

Department of Urology, Herlev-Gentofte Hospital

Locations

Urological Research Unit, Rigshospitalet

Copenhagen, Copenhagen N, Denmark

Site Status: RECRUITING

Department of Urology, Herlev-Gentofte Hospital

Gentofte Municipality, Hellerup, Denmark

Site Status: RECRUITING

Zealand University Hospital

Roskilde, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Anna Kristensen-Alvarez, MD

Role: CONTACT

anna.kristensen-alvarez@regionh.dk

+4535456152

Facility Contacts

Anna Kristensen-Alvarez, MD

Role: primary

anna.kristensen-alvarez@regionh.dk

+4535456152

Andreas Røder, Prof.,MD,PhD

Role: backup

andreas.roeder@regionh.dk

+4535456152

Anna Kristensen-Alvarez, MD

Role: primary

anna.kristensen-alvarez@regionh.dk

+4535456152

Mikkel M Fode, Prof.,MD,PhD

Role: backup

mikkel.mejlgaard.fode@regionh.dk

+4538680140

Anna Kristensen-Alvarez, MD

Role: primary

anna.kristensen-alvarez@regionh.dk

+4535456152

References

Kristensen-Alvarez A, Fode M, Stroomberg HV, Nielsen KK, Arch A, Lonn LB, Taudorf M, Widecrantz SJ, Roder A. 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. Trials. 2024 Sep 2;25(1):574. doi: 10.1186/s13063-024-08409-x.

Reference Type: DERIVED

PMID: 39223593 (View on PubMed)

Other Identifiers

P-2022-183

Identifier Type: OTHER

Identifier Source: secondary_id

H-22001990

Identifier Type: -

Identifier Source: org_study_id