Plain English Summary
Background and study aims
Benign prostate enlargement is a common disease in older men where a small gland called the prostate becomes enlarged, putting pressure on the bladder and the tube through which urine passes. This may cause difficulty starting urination, a frequent need to urinate, and difficulty fully emptying the bladder. Transurethral resection of the prostate (TURP) is a surgical procedure where an electric wire loop heated by radio waves is used to remove excess prostate tissue, reducing the pressure on your bladder. Prostate vaporization and enucleation (ThuVEP) is a new treatment option in which a laser is used to remove the excess tissue. The aim of this study is to find out whether ThuVEP is a safe and effective treatment for benign prostate enlargement.
Who can participate?
Men diagnosed with benign prostate enlargement.
What does the study involve?
We collected data from 29 patients who underwent ThuVEP and 30 patients who underwent TURP before the operation and at 3, 6, 9 and 12 months after the operation.
What are the possible benefits and risks of participating?
Both operations are widely used in clinical practice and may help with the patients’ urination difficulties. There are no additional risks of participating.
Where is the study run from?
Taipei Veterans General Hospital (Taiwan).
When is the study starting and how long is it expected to run for?
From August 2010 to August 2013.
Who is funding the study?
Taipei Veterans General Hospital (Taiwan).
Who is the main contact?
Dr Tzu-Ping Lin
tplin63@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Tzu-Ping Lin
ORCID ID
Contact details
Division of Urology
Department of Surgery
Taipei Veterans General Hospital
No. 201
Section 2
Shih-Pai Road
Taipei
11217
Taiwan
+886 (0)2 2875 7519
tplin63@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
VGHIRB: 201007014IC
Study information
Scientific title
Vapoenucleation of the prostate using a high-power thulium laser: a one-year follow-up study
Acronym
Study hypothesis
Prostate vaporization and enucleation is a novel treatment option for bladder outlet obstruction caused by benign prostate enlargement. Using a high-power thulium laser to accomplish vapoenucleation of the prostate (ThuVEP) is safe and effective.
Ethics approval
Taipei Veterans General Hospital, Taipei, Taiwan (VGHIRB) 201007014IC
Study design
Non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Urinary frequency, nocturia, weak stream, or urine retention
Intervention
We prospectively collected and analyzed data from 29 patients who underwent vapoenucleation of the prostate (ThuVEP) between August 2010 and May 2012. The control group included 30 patients who underwent traditional transurethral resection of the prostate (TURP). Operative variables, patient profiles, preoperative and postoperative urine flow rates, prostate volume (measured using transrectal ultrasonography), and the international prostate symptom score (IPSS) were recorded and analyzed using a two-tailed Student’s t-test and analysis of variance.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Operative variables obtained before the operation
2. Patient profiles obtained before the operation
3. Urine flow rates obtained before the operation and at 3, 6, 9 and 12 months after the operation
4. Prostate volume (measured using transrectal ultrasonography) obtained before the operation and at 3, 6, 9 and 12 months after the operation
5. International prostate symptom score (IPSS) via questionnaires obtained before the operation and at 3, 6, 9 and 12 months after the operation
Secondary outcome measures
1. Urine flow rates obtained at 6, 9 and 12 months after the operation
2. Prostate volume (measured using transrectal ultrasonography) obtained at 6, 9 and 12 months after the operation
3. International prostate symptom score (IPSS) via questionnaires obtained at 6, 9 and 12 months after the operation
Overall trial start date
01/08/2010
Overall trial end date
01/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. International prostate symptom score (IPSS) >7
2. Maximum urinary flow rate (Qmax) <15 mL/s
3. Normal level of age-specific prostate-specific antigen (PSA)
4. Patients with abnormal levels of age-specific PSA or positive findings on digital rectal examination underwent transrectal ultrasonography (TRUS)-guided biopsy to rule out prostate cancer. Ten patients underwent TRUS-guided biopsy before the operation
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
35
Participant exclusion criteria
Prostate cancer
Recruitment start date
01/08/2010
Recruitment end date
31/05/2012
Locations
Countries of recruitment
Taiwan
Trial participating centre
Taipei Veterans General Hospital
No.201, Sec. 2, Shipai Rd
Beitou District
Taipei
11217
Taiwan
Funders
Funder type
Hospital/treatment centre
Funder name
Taipei Veterans General Hospital (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25956819