NCT05784909

Brief Summary

new treatment modality for BPH , less invasive and more effective.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 14, 2023

Last Update Submit

March 14, 2023

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • evaluation of the IPSS

    to assess the success of treatment ,pre-operative and postoperative questionnaire will be done

    1 month after treatment

  • duration of the operation

    minutes or hours needed for the procedure

    intra-operative

Study Arms (1)

patients diagnosed with bladder outlet obstruction due to BPH

EXPERIMENTAL

all symptomatic patients with BPH with failure medical management or prefer minimal invasive procedure from the start.

Device: rezum

Interventions

rezumDEVICE

Technique With the patient in a lithotomy position, after cystoscopy, an RF current is applied to. Water vapour is delivered through a retractable vapor needle via emitter holes in the transurethral device. This is done in 9-second bursts to the transition zone of the prostate, where, via convection, it diffuses evenly throughout the target tissue. The depth of the needle penetrating is approximately 10 mm. Upon contact with body-temperature tissue, the water vapour then condenses. This phase shift to a liquid state dispenses concentrated energy onto the cell membranes of the target tissue, triggering instant cell necrosis. Overlapping injection sites can be established with repeated applications in order to fully target areas of hypertrophy. Saline flush irrigation is used to both cool the urethra and to promote visualization. At the end of the procedure Urethral catheter is fixed for 1-3 days.

patients diagnosed with bladder outlet obstruction due to BPH

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any patient diagnosed with BPH

You may not qualify if:

  • PATIENT REFUSING TO PARTICIPITATE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Zhang SJ, Qian HN, Zhao Y, Sun K, Wang HQ, Liang GQ, Li FH, Li Z. Relationship between age and prostate size. Asian J Androl. 2013 Jan;15(1):116-20. doi: 10.1038/aja.2012.127. Epub 2012 Dec 10.

    PMID: 23223031BACKGROUND

  • Vuichoud C, Loughlin KR. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol. 2015 Oct;22 Suppl 1:1-6.

    PMID: 26497338BACKGROUND

  • Kim EH, Larson JA, Andriole GL. Management of Benign Prostatic Hyperplasia. Annu Rev Med. 2016;67:137-51. doi: 10.1146/annurev-med-063014-123902. Epub 2015 Sep 2.

    PMID: 26331999BACKGROUND

  • Magistro G, Chapple CR, Elhilali M, Gilling P, McVary KT, Roehrborn CG, Stief CG, Woo HH, Gratzke C. Emerging Minimally Invasive Treatment Options for Male Lower Urinary Tract Symptoms. Eur Urol. 2017 Dec;72(6):986-997. doi: 10.1016/j.eururo.2017.07.005. Epub 2017 Jul 19.

    PMID: 28734706BACKGROUND

  • Garden EB, Shukla D, Ravivarapu KT, Kaplan SA, Reddy AK, Small AC, Palese MA. Rezum therapy for patients with large prostates (>/= 80 g): initial clinical experience and postoperative outcomes. World J Urol. 2021 Aug;39(8):3041-3048. doi: 10.1007/s00345-020-03548-7. Epub 2021 Jan 3.

    PMID: 33392646BACKGROUND

  • Elterman D, Shepherd S, Saadat SH, Alshak MN, Bhojani N, Zorn KC, Rijo E, Misrai V, Lajkosz K, Chughtai B. Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes. Can J Urol. 2021 Oct;28(5):10824-10833.

    PMID: 34657655BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mohamed M Gadalmoulah, phd

    professor

    STUDY DIRECTOR

Central Study Contacts

Mohamed A Zamra, Msc

CONTACT

+971508079718mohamedzomrah@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist of urology

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 27, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share