Prostate adenoma, also known as benign prostatic hypertrophy or hyperplasia (BPH), involves an increase in the size of the prostate, forming a benign tumor. It is the most common benign tumor in men, generally affecting those over 40 years old. The risk of BPH is more than 50% in men aged 50 to 60 and rises to 90% in men by age 80. This hyperplasia leads to altered urinary flow and bladder outlet obstruction, referred to as "lower urinary tract symptoms" or LUTS, which become more frequent with age. These symptoms are categorized as obstructive or irritative. In the early stages, men with BPH may have difficulty starting urination and may feel as if their bladder is not completely empty. As a result, they need to urinate more often, especially at night, a condition known as nocturia. Additionally, the volume and velocity of the urinary flow may decrease significantly, as evidenced by flow measurements, and residual urine discharge may occur at the end of urination. High-intensity focused ultrasound (HIFU) is a medical technique that uses high-intensity ultrasonic waves to treat various medical conditions, including malignant and benign tumors, without the need for invasive surgery or ionizing radiation. HIFU generates heat between 80° to 95°C at the focal point, causing necrosis of the targeted area with pinpoint accuracy. In urology, HIFU is used to treat prostate cancer in a minimally invasive manner, with focused ultrasounds delivered endorectally using a transducer that targets the treatment area with real-time monitoring. Exclusively targeted HIFU treatment has been suggested for BPH, where localized necrosis of the side lobes reduces the volume of the prostatic transition zone, alleviating compression of the prostatic urethra and improving urinary symptoms. This new study was initiated to evaluate the safety and efficacy of HIFU for BPH treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
high-intensity focused ultrasound treatment of benign prostatic hyperplasia
Clinique Saint Vincent
Besançon, France
NOT_YET_RECRUITINGClinique Tivoli-Ducos
Bordeaux, France
NOT_YET_RECRUITINGGroupe Hospitalier Pellegrin
Bordeaux, France
NOT_YET_RECRUITINGCHU de Lille
Lille, France
NOT_YET_RECRUITINGHCL_Hôpital Edouard Herriot
Lyon, France
RECRUITINGCH Matigues
Martigues, France
RECRUITINGHôpital Foch
Suresnes, France
NOT_YET_RECRUITINGClinique Saint Michel
Toulon, France
NOT_YET_RECRUITINGHôpitaux de Toulouse
Toulouse, France
NOT_YET_RECRUITINGRate of adverse events
Phase 1 Presence of significant cavitation that may be associated with adverse effects. Repeated urethral involvement that could damage the urethra. Absence of serious adverse effects (Clavien-Dindo ≥ III) directly attributable to the HIFU treatment procedure at 3 months of follow-up. Based on these elements, the scientific committee will analyze the cause-and-effect relationship between the indicators observed during treatment and the adverse effects.
Time frame: 3 months
Rate of patients with two of the following criteria ( Δ Qmax ≥ 50%, Δ IPSS ≥30%, Homogeneous necrosis observed on MRI)
Phase 1 Efficacy : Efficacy will be considered satisfactory if at least two of the following three conditions are met: Significant improvement in the maximum flow defined by Δ Qmax ≥ 50% of the initial flow or by a removal of the urinary catheter or supra-pubic catheter in included patients with urinary retention. Improvement in obstructive and irritative symptoms 3 months after treatment, defined by a reduction in the IPSS score defined by Δ IPSS ≥30% Homogeneous necrosis observed on MRI
Time frame: 3 months
Rate of patients that meet the four evaluation criteria (Absence of AD Clavien-Dindo ≥ III + ΔQmax ≥ 50% + Δ IPSS ≥30% + IPSS-QoL score ≤2)
Phase 2 Efficacy of the treatment To validate phase 2, 80% of patients are expected to meet the four evaluation criteria below after 6 months. Evaluation of urinary symptoms, continence, the erectile function, postoperative complications using a composite "tetrafecta" score defined by 4 criteria: 1. Absence of serious adverse effects relating to the HIFU procedure, Clavien-Dindo ≥ III after 6 months. 2. Significant improvement in the maximum flow defined by ΔQmax ≥ 50% of the initial flow after 6 months, or by a removal of the urinary catheter after 3 months in included patients with urinary retention. 3. Improvement in obstructive and irritative symptoms 6 months after treatment, defined by a reduction in the IPSS score defined by Δ IPSS ≥30% 4. Improvement in quality of life 6 months after treatment defined by an IPSS-QoL score ≤2
Time frame: 6 months
Rate of adverse events
Treatment safety 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months after treatment will be evaluated by: The rate of patients who experienced at least one adverse event with a Clavien-Dindo grade ≥ III The rate of patients with an SAE linked to the procedure The rate of patients with an SAE linked to the MD The rate of patients with unscheduled consultation and/or secondary re-hospitalization due to problems in connection with the procedure or the MD
Time frame: 36 months
Rate of patients with a significant decrease of prostate size
The impact of treatment on changes in prostate size will be evaluated by MRI and ultrasound 3 months, 6 months, 12 months after treatment.
Time frame: 36 months
The impact of the HIFU treatment on the urinary flow
The impact of the HIFU treatment on the urinary flow will be evaluated by measuring Q max 1 month, 3 months, 6 months, 12 months after treatment defined by: The rate of patient with ΔQmax ≥ 50% Rate of patients with removal of the urinary catheter after 3 months in included patients with urinary retention. The rate of patients with Qmax ≥ 15 ml/s
Time frame: 36 months
Rate of patients with a significant decrease of RPM
The impact of the HIFU treatment on bladder voiding will be evaluated by measuring RPM 1 month, 3 months, 6 months, 12 months after treatment, defined by: The rate of patients with RPM ≤ 150 ml The rate of patients with Δ RPM ≥50%
Time frame: 36 months
The rate of patients with a significant improvment of obstructive and irritative symptoms of the lower urinary tract
The effect of the treatment on the obstructive and irritative symptoms of the lower urinary tract will be evaluated using the IPSS score 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after treatment, defined by: The rate of patients with Δ IPSS ≥30% The rate of patients with an IPSS score ≤ 7
Time frame: 36 months
The rate of patients with a significant improvment of LUTS-related quality of life
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The evaluation of the impact of the HIFU treatment on LUTS-related quality of life 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after treatment, defined by: The rate of patients with an IPSS-QoL score ≤ 2
Time frame: 36 months
The rate of patients with an improvment in the erectile function
The evaluation of the impact of treatment on the erectile function 1 month, 3 months, 6 months, 12 months and 36 months after treatment, defined by: The rate of patients with a Δ IIEF score ≤ 5
Time frame: 36 months
The evaluation of the impact of treatment on the ejaculatory function
The evaluation of the impact of treatment on the ejaculatory function 1 month, 3 months, 6 months, 12 months and 36 months after treatment, defined by: The rate of patients with a Δ MSHQ-EjD score \< 25 The rate of patients with MSHQ-EJD \<10 (no ejaculatory dysfunction or mild dysfunction) The rate of patients who say they suffer from retrograde ejaculation
Time frame: 36 months
The rate of patients with a recurrence over the follow-up period up to 36 months
The recurrence rate over the follow-up period up to 36 months will be evaluated by the number of patients with urinary retention who required catheterization or surgery for BPH.
Time frame: 36 months
The cost related to the use of HIFU
The estimation of costs related to the use of HIFU will be carried out by calculating the costs associated with consumables, the time of medical staff directly involved in the procedure, and the duration of hospitalization.
Time frame: 36 months
Efficiency
Efficiency will be estimated through the consideration of costs associated with HIFU treatment, follow-up costs, retreatments, and the duration of medical leave of absence.
Time frame: 36 months