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

ConditionsProstatic HyperplasiaLower Urinary Tract Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorRigshospitalet, Denmark

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transurethral Microwave Thermotherapy

    Procedure/Surgery

    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.

  • Prostate Artery Embolisation

    Procedure/Surgery

    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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: TUMTExperimental treatment 1 intervention
Group B: PAEExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 months post-procedure.

Secondary outcomes

1

Mean IPSS of the TUMT and PAE arm at 3,12, 24 and 60 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.

Time frame
3, 12, 24 and 60 months post-procedure.
2

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

The International Prostate Symptom Score-Quality of Life (IPSS-QoL) is a validated, reproducible, patient-reported outcome measure to assess the frequency of symptoms from urinary problems and associated QoL. It is a validated screening tool for depression. The IPSS-QoL has 1 item that rates QoL (feelings if current symptoms lasted for life) on a scale ranging from 0 (delighted) to 6 (terrible).

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

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

The EQ-5D is a broadly used, reliable and generic health utility instrument. It has five dimensions each with one item: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D contains a visual analog scale (VAS) where the patient rates his health from 0 (worst imaginable) to 100 (best imaginable). Treatment effects will be assessed by measuring health status with EQ-5D at different points in time. The EQ-5D is the most widely applied instrument for health-economic assessment worldwide. Its index values are used in the estimation of quality-adjusted life year (QALY) gains in economic evaluations of healthcare interventions. EQ-5D profile and EQ VAS data provide additional evidence on the relative effectiveness of healthcare interventions. A health economic evaluation of the two procedures will be performed using the EQ-5D-5L score of the two arms during the follow up period.

Time frame
3, 6, 12, 24 and 60 months post-procedure.
4

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

The BPH Impact Index (BII) is a self-reported, validated, disease-specific instrument for quantifying the interference of lower urinary tract symptoms(LUTS) on the patients mental health and activity. As a measure of Quality of Life (QoL), it is used to determine treatment outcomes in men with symptomatic benign prostatic hyperplasia. The BII is a four-item questionnaire that addresses discomfort, worry, bother, and functional interference from any urinary problems. It is scored by addition yielding a range from 0 (no impact) to 13 (great impact).

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

Other outcomes

1

Mean procedure time for conduction of the TUMT and PAE procedures

Procedure time is the time of the patient procedure.

Time frame
procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Herlev and Gentofte Hospital

Collaborator

Source ClinicalTrials.gov
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