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Outcomes of Water Vapor Thermal Therapy (REZUM) in Management of Symptomatic Patients With Benign Prostatic Enlargement

Primary Purpose

Benign Prostatic Hyperplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rezum
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: any patient diagnosed with BPH Exclusion Criteria: PATIENT REFUSING TO PARTICIPITATE

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    patients diagnosed with bladder outlet obstruction due to BPH

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    evaluation of the IPSS
    to assess the success of treatment ,pre-operative and postoperative questionnaire will be done
    duration of the operation
    minutes or hours needed for the procedure

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2023
    Last Updated
    March 14, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05784909
    Brief Title
    Outcomes of Water Vapor Thermal Therapy (REZUM) in Management of Symptomatic Patients With Benign Prostatic Enlargement
    Official Title
    Outcomes of Water Vapor Thermal Therapy (REZUM) in Management of Symptomatic Patients With Benign Prostatic Enlargement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    new treatment modality for BPH , less invasive and more effective.
    Detailed Description
    Benign prostatic hyperplasia (BPH) is a common urological condition characterized by progressive increase in the size of the prostate gland. It is a disease of ageing, affecting 40% of men in their 50s and 90% of men over 90 years causing bladder outflow obstruction (BOO), which results in lower urinary tract symptoms (LUTS) which have a significant impact on quality of life (QoL). The current management for LUTS caused by BOO secondary to BPH includes conservative approaches (watchful waiting and lifestyle modifications), pharmacotherapy and surgical intervention. The Surgical interventions include open surgery (suprapubic and perineal approaches),transurethral resection of the prostate (TURP) which was a revolutionary step in the management of BPH, and was considered the first minimally invasive treatment for prostate enlargement and With the improvement of endoscopes, development and incorporation of new technologies into the medical field, minimally invasive procedures have been more and more introduced as surgical options to treat BPH . Minimally invasive procedures include water vapor thermal therapy (REZUM), trans urethral needle ablation, trans urethral microwave thermotherapy, prostate urethral lift and prostate artery embolization. REZUM (water vapor thermal therapy) is considered one of the advanced minimal invasive procedure that uses the principles of convective heat transfer that exploits the thermodynamic properties of water to remove the excess prostate tissue that is pressing on the urethra. The therapy is targeted to a defined area because steam will travel only between cells until it encounters natural collagen barriers or the prostate capsule itself. After the REZUM procedure, the body creates an inflammatory response, which takes two to four months to completely resolve. Initially, there will be swelling in the prostate, which can cause restriction of flow and cause more difficulty and frequency of urination. In general, after the procedure symptoms will get worse before they get better and improved. Erections are not affected by the REZUM procedure and there is 1% to 2% chance of retrograde ejaculation and his is a significantly lower percentage than in other prostate procedures. Advantages of REZUM: Can be performed under sedation only Day case procedure Strong short-term safety profile No reports of de novo sexual dysfunction Suitable for patients with an obstructing median lobe Short procedure time Good improvement in subjective and objective outcome measures: IPSS, QoL, Qmax and PVR Cost effective Disadvantages of REZUM: Limited long-term data available Not suitable for patients with history of recurrent urinary tract infections Not suitable for large prostate size (>120 cc) Not suitable for patients if prior invasive procedure for treatment of prostate or prior radiation on prostate >50% patients require catheter post procedure

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients diagnosed with bladder outlet obstruction due to BPH
    Arm Type
    Experimental
    Arm Description
    all symptomatic patients with BPH with failure medical management or prefer minimal invasive procedure from the start.
    Intervention Type
    Device
    Intervention Name(s)
    rezum
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    evaluation of the IPSS
    Description
    to assess the success of treatment ,pre-operative and postoperative questionnaire will be done
    Time Frame
    1 month after treatment
    Title
    duration of the operation
    Description
    minutes or hours needed for the procedure
    Time Frame
    intra-operative

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: any patient diagnosed with BPH Exclusion Criteria: PATIENT REFUSING TO PARTICIPITATE
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed A Zamra, Msc
    Phone
    +971508079718
    Email
    mohamedzomrah@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed M Gadalmoulah, phd
    Organizational Affiliation
    professor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23223031
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26497338
    Citation
    Vuichoud C, Loughlin KR. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol. 2015 Oct;22 Suppl 1:1-6.
    Results Reference
    background
    PubMed Identifier
    26331999
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28734706
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33392646
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34657655
    Citation
    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.
    Results Reference
    background

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    Outcomes of Water Vapor Thermal Therapy (REZUM) in Management of Symptomatic Patients With Benign Prostatic Enlargement

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