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

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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