Condition category
Urological and Genital Diseases
Date applied
25/02/2015
Date assigned
06/03/2015
Last edited
11/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Taipei Veterans General Hospital

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25956819

Publication citations

Additional files

Editorial Notes