The Clinical Efficacy of Rezūm Therapy Versus Bipolar Trans-urethral Resection of the Prostate for Treatment Benign Prostatic Hyperplasia

Ain Shams University

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Procedure: B-TURP procedure; Procedure: Rezum procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT06116370

surgical treatments of BPH

Details and patient eligibility

About

We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of 50-120gm size.

Full description

For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay. In contrast to monopolar TURP (M-TURP), where prolonged resection carries the risk of transurethral resection (TUR) syndrome, bipolar transurethral resection of prostate (B-TURP), especially in large prostates was a promising procedure for urologists, but unfortunately, the morbidity rate of B-TURP remains high [4]. Therefore, newer minimally invasive procedures have been introduced to provide alternative surgical options to TURP.

Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water vapour therapy as a treatment option for BPH patients with small prostate size <80 gm and for those wishing to maintain antegrade ejaculation. While they still offer no clear recommendation to Rezūm use for those with large prostates. Early studies on this topic have found out promising results.

Enrollment: 100 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 50-80 years
• prostate volumes of 50-120 ml
• sexually active
• severe LUTS
• [Q max] of <10 ml/s
• [IPSS] of >20)
• failed medical treatment with alpha blockers

Exclusion criteria

• prostate cancer
• Neurogenic bladder
• urethral stricture
• urinary bladder stone
• previous prostatic surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

BPH patients treated with Rezum procedure

Active Comparator group

Description:

Patients aged 50-80 years with prostate volumes of 50-120 ml, sexually active, and have severe LUTS treated with Rezum procedure

Treatment:

Procedure: Rezum procedure

BPH patients treated with B-TURP procedure

Active Comparator group

Description:

Patients aged 50-80 years with prostate volumes of 50-120 ml, sexually active, and have severe LUTS treated with Rezum procedure

Treatment:

Procedure: B-TURP procedure