Using a high-power thulium laser system in the operation to treat benign prostate hyperplasia

ISRCTN	ISRCTN52339705
DOI	https://doi.org/10.1186/ISRCTN52339705
Secondary identifying numbers	VGHIRB: 201007014IC

Submission date: 25/02/2015
Registration date: 06/03/2015
Last edited: 11/05/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Tzu-Ping Lin
Scientific

Division of Urology
Department of Surgery
Taipei Veterans General Hospital
No. 201
Section 2
Shih-Pai Road
Taipei
11217
Taiwan

Phone	+886 (0)2 2875 7519
Email	tplin63@gmail.com

Study information

Study design	Non-randomised study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Vapoenucleation of the prostate using a high-power thulium laser: a one-year follow-up study
Study objectives	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(s)	Taipei Veterans General Hospital, Taipei, Taiwan (VGHIRB) 201007014IC
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2010
Completion date	01/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	35
Key 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
Key exclusion criteria	Prostate cancer
Date of first enrolment	01/08/2010
Date of final enrolment	31/05/2012

Locations

Countries of recruitment

Taiwan

Study participating centre

Taipei Veterans General Hospital

No.201, Sec. 2, Shipai Rd
Beitou District
Taipei
11217
Taiwan

Sponsor information

Taipei Veterans General Hospital
Hospital/treatment centre

Department of Urology
No. 201
Section 2
Shih-Pai Road
Taipei
11217
Taiwan

"ROR"	https://ror.org/03ymy8z76

Funders

Funder type

Hospital/treatment centre

Taipei Veterans General Hospital (Taiwan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	To be confirmed at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/05/2015		Yes	No