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

NCT05686525 | Recruiting DMC

• 2 other identifiers: H-22001990P-2022-183
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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).

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

Embolization, Therapeutic; Prostatic Artery Embolization; Transurethral Microwave Thermotherapy; Patient Reported Outcome Measures

Outcome Measures

Primary Outcomes (1)

• Mean IPSS of the TUMT and PAE arm 6 months after the procedure

  The International Prostate Symptom Score (IPSS) is a validated, reproducible, patient-reported outcome measure to assess lower urinary tract symptoms (LUTS) severity and response to treatment. The IPSS is made up of 7 questions and possible scores range from 0 to 35. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and a score of 20 to 35 indicates severe symptoms. If the patient has an indwelling catheter the IPSS score is 35.

  6 months post-procedure.

Secondary Outcomes (18)

• Mean IPSS of the TUMT and PAE arm at 3,12, 24 and 60 months after the procedure

  3, 12, 24 and 60 months post-procedure.

• Mean IPSS-QoL score of the TUMT and PAE arm at 3, 6, 12, 24 and 60 months after the procedure

  3, 6, 12, 24 and 60 months post-procedure.

• Mean EQ-5D-5L score of the TUMT and PAE arm at 3, 6, 12, 24 and 60 months after the procedure

  3, 6, 12, 24 and 60 months post-procedure.

• Mean BII score of the TUMT and PAE arm at 3, 6, 12, 24 and 60 months after the procedure

  3, 6, 12, 24 and 60 months post-procedure.

• Mean patient satisfaction with the TUMT and PAE treatment by Likert scale 1 and 3 months after the procedure

  1 and 3 months post-procedure.

Other Outcomes (1)

• Mean procedure time for conduction of the TUMT and PAE procedures

  procedure

Study Arms (2)

TUMT

EXPERIMENTAL

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.

Procedure: Transurethral Microwave Thermotherapy

PAE

EXPERIMENTAL

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.

Procedure: Prostate Artery Embolisation

Interventions

Transurethral Microwave Thermotherapy 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.

Also known as: TUMT

TUMT

Prostate Artery Embolisation 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.

Also known as: PAE

PAE

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Active bladder cancer (patients with pTa low-grade tumors are allowed).
• Previous pelvic radiation for cancer treatment.
• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Herlev and Gentofte Hospital: collaborator

Study Sites (3)

Urological Research Unit, Rigshospitalet

Copenhagen, Copenhagen N, 2200, Denmark

RECRUITING

Department of Urology, Herlev-Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

RECRUITING

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 39223593 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Andreas Røder, Prof.,MD,PhD

  Urological Research Unit, Rigshospitalet

  STUDY DIRECTOR

• Mikkel M Fode, Prof.,MD,PhD

  Department of Urology, Herlev-Gentofte Hospital

  STUDY DIRECTOR

Central Study Contacts

Anna Kristensen-Alvarez, MD

CONTACT

+4535456152; anna.kristensen-alvarez@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will randomize approximately 220 patients with an anticipated 10% dropout (N = 200). The study will assign patients in a 1:1 manner to either Arm 1: TUMT or Arm 2: PAE.

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: January 17, 2023
• Study Start: October 27, 2022
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)