Comparative Study Between Rezum Therapy in Small and Large Prostates

khaled Abdelsattar Gad Ibrahim

Status: Completed

Conditions: Prostate Hyperplasia

Treatments: Device: Rezum therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06818383

Rezum therapy in prostate

Details and patient eligibility

About

The investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) in small and large prostates.

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 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 investigators still offer no clear recommendation to Rezūm use for those with large prostates.

Enrollment: 178 patients

Sex: Male

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. prostate size 45-75 gm
2. sexually active
3. mod - sever LUTS
4. Q max < 15
5. IPSS > 15
6. failed medical treatment with alpha blockers

Exclusion criteria

1. neurogenic bladder
2. urethral stricture
3. UB stones
4. cancer prostate

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

178 participants in 2 patient groups

BPH patients have small prostates treated with Rezum

Active Comparator group

Description:

Patients aged 45-75 years with prostate volumes of 50-80 ml, sexually active, and have severe LUTS treated with Rezum procedure

Treatment:

Device: Rezum therapy

BPH patients have large prostates treated with Rezum

Active Comparator group

Description:

Patients aged 45-75 years with prostate volumes of 80-120 ml, sexually active, and have severe LUTS treated with Rezum procedure

Treatment:

Device: Rezum therapy