Using a high-power thulium laser system in the operation to treat benign prostate hyperplasia
ISRCTN | ISRCTN52339705 |
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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
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
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 |
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tplin63@gmail.com |
Study information
Study design | Non-randomised study |
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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 |
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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
Beitou District
Taipei
11217
Taiwan
Sponsor information
Hospital/treatment centre
Department of Urology
No. 201
Section 2
Shih-Pai Road
Taipei
11217
Taiwan
https://ror.org/03ymy8z76 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 09/05/2015 | Yes | No |