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
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
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
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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