Benign Prostatic HypertrophyNCT02533687
Comparison of Different Energy Sources During TUR-P
A study testing Bipolar TURP-1, Bipolar TURP-2 and Monopolar TURP in people with Benign Prostatic Hypertrophy, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
With this study, it is aimed to compare the operative results and complication rates in transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different bipolar and a monopolar energy sources. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy
- What is being tested?
- Bipolar TURP-1, Bipolar TURP-2 and Monopolar TURP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2020to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having an indication due to BPH
- Aged between 40 and 80 years old
Who cannot join
- Kidney failure due to BPH
- Any kind of coagulopathy or use of anticoagulants in the preoperative period
- History of any previous open or endoscopic prostate surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, School of Medicine, Department of Urology
Konya, 42075
About this study
Official title: Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate
With this study, it is aimed to compare the operative results and complication rates in transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different bipolar and a monopolar energy sources.
Read the detailed description
Following data will be collected and evaluated prospectively for the three groups of patients who will undergo TUR-P due to benign prostate hyperplasia (BPH) with one of the resectoscopes using different energy sources:
- Preoperative data: age, height, weight, body-mass index, concomitant morbidities, use of any drug, history of operation, duration of lower urinary tract symptoms, history of any previous treatment taken for BPH, serum level of prostate specific antigen, prostate volume, maximum and average urine flow rate, postmicturation residual urine volume, hemoglobin level
- Operative data: duration of operation, volume of resected tissue, observation of obturator reflex (if any), kind and size of the urethral catheter used
- Postoperative data: time to removal of urethral catheter, hospitalization duration, change in hemoglobin, rate of blood transfusion, any other complications
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- Bipolar TURP-1, Bipolar TURP-2, Monopolar TURP
- Keywords
- prostate, transurethral resection, bipolar, monopolar
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar TURP-1Procedure or surgery
Bipolar transurethral resection of prostate (TURP)
Bipolar TURP-2Procedure or surgery
Bipolar TURP
Monopolar TURPProcedure or surgery
Monopolar TURP
| Study group | Role | What they receive |
|---|---|---|
| Bipolar TURP-1 | Active comparator | Transurethral resection of prostate (TURP) with bipolar resectoscope (Gyrus brand) Receives: Procedure: Bipolar TURP-1 |
| Bipolar TURP-2 | Active comparator | TURP with bipolar resectoscope (Olympus brand) Receives: Procedure: Bipolar TURP-2 |
| Monopolar TURP | Active comparator | TURP with monopolar resectoscope (Karl Storz brand) Receives: Procedure: Monopolar TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uroflowmetry test
Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s).
Measured: Within the first 30 days after surgery.
Secondary outcomes (1)
Overall complication rates
Number of patients with any complications related with TURP (including hemorrhage, blood transfusion, urinary tract infections, urethral strictures) classified according to modified Clavien-Dindo classification.
Measured: Within the first 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startJul 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Due to unwillingness of surgeons to use monopolar energy \& technical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HypertrophyStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat AKAND, Selcuk University
- Investigators
- Murat Akand, MD, Principal investigator, Selcuk University, School of Medicine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533687
- Sponsor's protocol ID
- SU-TURP-BM-01
- Status last verified
- Nov 2019
- First submitted
- 23 Aug 2015
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.
PubMed 24972732Komura K, Inamoto T, Takai T, Uchimoto T, Saito K, Tanda N, Minami K, Uehara H, Takahara K, Hirano H, Nomi H, Kiyama S, Watsuji T, Azuma H. Could transurethral resection of the prostate using the TURis system take over conventional monopolar transurethral resection of the prostate? A randomized controlled trial and midterm results. Urology. 2014 Aug;84(2):405-11. doi: 10.1016/j.urology.2014.04.025. Epub 2014 Jun 21.
PubMed 24958486Nakamura A, Osonoi T, Terauchi Y. Relationship between urinary sodium excretion and pioglitazone-induced edema. J Diabetes Investig. 2010 Oct 19;1(5):208-11. doi: 10.1111/j.2040-1124.2010.00046.x.
PubMed 24843434Tang Y, Li J, Pu C, Bai Y, Yuan H, Wei Q, Han P. Bipolar transurethral resection versus monopolar transurethral resection for benign prostatic hypertrophy: a systematic review and meta-analysis. J Endourol. 2014 Sep;28(9):1107-14. doi: 10.1089/end.2014.0188. Epub 2014 Jun 5.
PubMed 24754254
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate
- ClinicalTrials.gov ID
- NCT02533687
- Acronym / sponsor ID
- SU-TURP-BM-01
- Conditions
- Benign Prostatic Hypertrophy
- Keywords
- prostate, transurethral resection, bipolar, monopolar
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to unwillingness of surgeons to use monopolar energy \& technical problems
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With this study, it is aimed to compare the operative results and complication rates in transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different bipolar and a monopolar energy sources.
Detailed description
Following data will be collected and evaluated prospectively for the three groups of patients who will undergo TUR-P due to benign prostate hyperplasia (BPH) with one of the resectoscopes using different energy sources:
- Preoperative data: age, height, weight, body-mass index, concomitant morbidities, use of any drug, history of operation, duration of lower urinary tract symptoms, history of any previous treatment taken for BPH, serum level of prostate specific antigen, prostate volume, maximum and average urine flow rate, postmicturation residual urine volume, hemoglobin level
- Operative data: duration of operation, volume of resected tissue, observation of obturator reflex (if any), kind and size of the urethral catheter used
- Postoperative data: time to removal of urethral catheter, hospitalization duration, change in hemoglobin, rate of blood transfusion, any other complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar TURP-1 | Active comparator | Procedure: Bipolar TURP-1Transurethral resection of prostate (TURP) with bipolar resectoscope (Gyrus brand) |
| Bipolar TURP-2 | Active comparator | Procedure: Bipolar TURP-2TURP with bipolar resectoscope (Olympus brand) |
| Monopolar TURP | Active comparator | Procedure: Monopolar TURPTURP with monopolar resectoscope (Karl Storz brand) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having an indication due to BPH
- Aged between 40 and 80 years old
Key exclusion criteria (3 listed)
- Kidney failure due to BPH
- Any kind of coagulopathy or use of anticoagulants in the preoperative period
- History of any previous open or endoscopic prostate surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar TURP-1Bipolar transurethral resection of prostate (TURP) | Procedure or surgery | Bipolar TURP-1 |
| Bipolar TURP-2Bipolar TURP | Procedure or surgery | Bipolar TURP-2 |
| Monopolar TURPMonopolar TURP | Procedure or surgery | Monopolar TURP |
Primary outcome
Uroflowmetry test
Time frame: Within the first 30 days after surgery.
Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s).
1 secondary outcome
Overall complication rates
Time frame: Within the first 30 days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 24972732Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.
- Background: PubMed 24958486Komura K, Inamoto T, Takai T, Uchimoto T, Saito K, Tanda N, Minami K, Uehara H, Takahara K, Hirano H, Nomi H, Kiyama S, Watsuji T, Azuma H. Could transurethral resection of the prostate using the TURis system take over conventional monopolar transurethral resection of the prostate? A randomized controlled trial and midterm results. Urology. 2014 Aug;84(2):405-11. doi: 10.1016/j.urology.2014.04.025. Epub 2014 Jun 21.
- Background: PubMed 24843434Nakamura A, Osonoi T, Terauchi Y. Relationship between urinary sodium excretion and pioglitazone-induced edema. J Diabetes Investig. 2010 Oct 19;1(5):208-11. doi: 10.1111/j.2040-1124.2010.00046.x.
- Background: PubMed 24754254Tang Y, Li J, Pu C, Bai Y, Yuan H, Wei Q, Han P. Bipolar transurethral resection versus monopolar transurethral resection for benign prostatic hypertrophy: a systematic review and meta-analysis. J Endourol. 2014 Sep;28(9):1107-14. doi: 10.1089/end.2014.0188. Epub 2014 Jun 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Akand, MD principal investigator
Selcuk University, School of Medicine, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar TURP-1, Bipolar TURP-2 and Monopolar TURP in people with Benign Prostatic Hypertrophy, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uroflowmetry test (time frame: Within the first 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533687, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.