Comparative Study Between Rezum Therapy in Small and Large Prostates

NCT ID: NCT06818383

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Hyperplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

two groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BPH patients have small prostates treated with Rezum

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

Group Type ACTIVE_COMPARATOR

Rezum therapy

Intervention Type DEVICE

minimal invasive technique for treating BPH

BPH patients have large prostates treated with Rezum

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

Group Type ACTIVE_COMPARATOR

Rezum therapy

Intervention Type DEVICE

minimal invasive technique for treating BPH

Interventions

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Rezum therapy

minimal invasive technique for treating BPH

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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khaled Abdelsattar Gad Ibrahim

OTHER

Sponsor Role lead

Responsible Party

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khaled Abdelsattar Gad Ibrahim

consultatnt doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed Samir Salem, MD

Role: STUDY_CHAIR

Locations

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The Armed Forces College of Medicine (AFCM)

Cairo, Nozha, Egypt

Site Status

Countries

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Egypt

References

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Bole R, Gopalakrishna A, Kuang R, Alamiri J, Yang DY, Helo S, Ziegelmann MJ, Kohler TS. Comparative Postoperative Outcomes of Rezum Prostate Ablation in Patients with Large Versus Small Glands. J Endourol. 2020 Jul;34(7):778-781. doi: 10.1089/end.2020.0177. Epub 2020 Jun 12.

Reference Type BACKGROUND
PMID: 32408768 (View on PubMed)

McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.

Reference Type BACKGROUND
PMID: 30677455 (View on PubMed)

Dixon CM, Cedano ER, Pacik D, Vit V, Varga G, Wagrell L, Larson TR, Mynderse LA. Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia. Res Rep Urol. 2016 Nov 21;8:207-216. doi: 10.2147/RRU.S119596. eCollection 2016.

Reference Type BACKGROUND
PMID: 27921028 (View on PubMed)

Related Links

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https://pmc.ncbi.nlm.nih.gov/articles/PMC7779102/

efficay of Rezum tehrapy in large prostates

Other Identifiers

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Rezum therapy in prostate

Identifier Type: -

Identifier Source: org_study_id

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