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High Power Thulium Vaporization vs Transurethral Resection of the Prostate for Treatment of BPH

Primary Purpose

Benign Prostatic Hyperplasia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

M-TURP

THUVAP

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients' age ≥50 years
LUTS secondary to BOO due to BPH who failed medical treatment
International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
ASA (American society of anaesthesiologists) score ≤3.
TRUS prostate size between 30-80 ml

Exclusion Criteria:

Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
Active urinary tract infection,
Presence of active bladder pathology (within the last 2 years)
Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
Patient has had an acute myocardial infarction or open-heart surgery <180 days prior to the date of informed consent

Sites / Locations

Urology and nephrology center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

THUVAP

M-TURP

Arm Description

thulium vaporization

monopolar transurethral resection

Outcomes

Primary Outcome Measures

IPSS score at 12 months .

international prostate symptom score (both voiding & storage symptom subscores )

Secondary Outcome Measures

Full Information

NCT ID

NCT03264482

First Posted

August 14, 2017

Last Updated

July 24, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03264482

Brief Title

High Power Thulium Vaporization vs Transurethral Resection of the Prostate for Treatment of BPH

Official Title

Treatment of Benign Prostatic Hyperplasia: High Power Thulium Laser Front Fire Vaporization VS Transurethral Resection - A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

May 20, 2017 (Actual)

Primary Completion Date

December 2, 2018 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a prospective randomized trial.

Detailed Description

When Lower Urinary Tract Symptoms (LUTS) are refractory to medical therapy and bothersome enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has been the historical reference-standard procedures for prostate size between 30-80 ml for years. Over the past decade, New minimally invasive surgical therapies (MIST), new medications, and novel combinations of medical therapies have expanded the number of treatment options ranging from watchful waiting to open surgery. The range of treatment options is as broad as the BPH spectrum of symptoms. These treatment options include prostate vaporization, resection and enucleation using various energy sources , however the main theme for all these new procedures that they were done using physiological saline as an irrigant nullifying the risk of TUR syndrome. One of the biggest changes in surgical treatment of BPH over the past 2 decades has been the introduction and use of lasers. Two-micron (Thulium) continuous-wave (CW) laser may have several advantages, including sufficient homeostasis with minimal thermal injury, more precise tissue incision, and operation in CW/pulsed modes. Pieces of the prostate are vaporized small enough to evacuate through the resectoscope sheath and use of a mechanical tissue morcellator is not required. The introduction of the latest generation of the Thulium laser namely "200w laser " raises the expectations of the prostate vaporization.

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

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

THUVAP

Arm Type

Active Comparator

Arm Description

thulium vaporization

Arm Title

M-TURP

Arm Type

Active Comparator

Arm Description

monopolar transurethral resection

Intervention Type

Procedure

Intervention Name(s)

M-TURP

Intervention Description

endoscopic resection of the prostatic adenoma

Intervention Type

Procedure

Intervention Name(s)

THUVAP

Intervention Description

vaporization of prostatic adenoma via THULIUM laser

Primary Outcome Measure Information:

Title

IPSS score at 12 months .

Description

international prostate symptom score (both voiding & storage symptom subscores )

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients' age ≥50 years LUTS secondary to BOO due to BPH who failed medical treatment International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8) Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment. ASA (American society of anaesthesiologists) score ≤3. TRUS prostate size between 30-80 ml Exclusion Criteria: Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease Active urinary tract infection, Presence of active bladder pathology (within the last 2 years) Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary. Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding. Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg). Patient has had an acute myocardial infarction or open-heart surgery <180 days prior to the date of informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed M. Elshal, MD

Organizational Affiliation

Mansoura University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Urology and nephrology center

City

Al Manşūrah

State/Province

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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High Power Thulium Vaporization vs Transurethral Resection of the Prostate for Treatment of BPH

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