Prostatic HyperplasiaNCT03936244
Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms
A study testing Transurethral Resection of the Prostate (TURP) in people with Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Hospital Universitario de Fuenlabrada at 1 site in Spain.
Trial summary
Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Transurethral Resection of Prostate
- What is being tested?
- Transurethral Resection of the Prostate (TURP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2014to 12 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sign the informed consent voluntarily and will be willing to follow-up
- Prostate volume <80 g
- Meet any conditions (1) Diagnose of LUTS due to refractory to drugs BPH. (2) presenting complications derived from BPH (bladder calculi, recurrent haematuria, recurrent urinary tract infections, acute urinary retention)
- The use of antiplatelet agents or anticoagulant drugs is allowed.
Who cannot join
- Previous history of pelvic surgery
- Previous history of pelvic radiotherapy
- Previous history of neurogenic bladder dysfunction
- Documented or suspected prostate carcinoma
- Patients with severe cardiopulmonary disease or severe mental disorders
- Poor compliance, and can not be followed up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Bipolar Plasmakinetic Transurethral Resection of the Prostate With Monopolar Transurethral Resection of the Prostate in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution
Read the detailed description
The study is a randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes (efficacy, complications and sequelae) for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution (Madrid, Spain)
- Being tested
- Transurethral Resection of the Prostate (TURP)
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral Resection of the Prostate (TURP)Device
Randomized allocation to M-TURP or PK-TURP
| Study group | Role | What they receive |
|---|---|---|
| M-TURP | Active comparator | The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Receives: Device: Transurethral Resection of the Prostate (TURP) |
| PK-TURP | Experimental | The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Receives: Device: Transurethral Resection of the Prostate (TURP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (with 7 questions) at 1, 3, 6, and 12 months after surgery.
Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows categorizing the lower urinary tract symptoms (LUTS) in 3 categories
- Mild LUTS: 0-7 points
- Moderate LUTS: 8-19 points
- Severe LUTS: 20-35 points
Measured: 12 months
Maximum Urinary Flow Rate (Qmax
Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.
Measured: 12 months
Postvoid Residual Urine (PVRU) Volume
Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery.
Measured: 12 months
Secondary outcomes (28)
Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire
We use the bother score item of the IPSS questionnaire (question 8) at 1, 3, 6, and 12 months after surgery to assess the quality of life (QoL) due to lower urinary tract symptoms (LUTS) Results: will range between 0 to 6 points Interpretation: allows categorizing the QoL in 3 categories
- Good QoL: 0-2 points
- Intermediate QoL: 3 points
- Poor QoL: 4-6points
Measured: 12 months
Number of Participants Reporting Sexual Activity in the Last Month
Measure Description: All patients were asked, Did you have sexual activity in the last month? Possible answers were yes or no.
Possible answers: yes or no.
Measurement moment: at 1, 3, 6 and 12 months after surgery.
Measured: 12 months
International Index of Erectile Function (IIEF-5)
International Index of Erectile Function (with 5 questions) at 1, 3, 6, and 12 months after surgery.
Results: the sum of the 5 items will range between 1 to 25 points Interpretation: allows categorizing the erectile function of patients
- Without erectile dysfunction: 22-25 points
- Mild erectile dysfunction: 17-21 points
- Mild to moderate erectile dysfunction: 12-16 points
- Moderate erectile dysfunction: 8-11 points
- Severe erectile dysfunction: 1-7 points
Measured: 12 months
Prostate Volume (PV)
Prostate volume was measured by transrectal ultrasound at 12 months after surgery
Measured: 12 months
Operative Time
Operative time (min)
Measured: Up to 24 hours
Irrigation Volume
Irrigation volume (L)
Measured: Up to 24 hours
Change in Plasmatic Sodium in 24 Hours Post-operation
Compared with the baseline, to demonstrate the sodium loss during operation
Measured: 24 hours after surgery
Change in Haemoglobin in 24 Hours Post-operation
Compared with the baseline, to demonstrate the blood loss during operation
Measured: 24 hours after surgery
Transfusion Rate
Number of participants requiring blood transfusion during, expressed in %
Measured: 1 month
Catheter Duration
Catheter duration (days)
Measured: 1 month
Hospital Stay
Hospital stay (days)
Measured: 1 month
Resected Tissue Weigh
Resected tissue weigh (grams)
Measured: Up to 24 hours
Resected Tissue Percentage
Compared with the baseline, to demonstrate the % of tissue loss during operation
Measured: Up to 24 hours
Speed Resection
Speed resection (g/min)
Measured: Up to 24 hours
Early Reoperation Rate
The ratio of patient who need reoperation because bleeding complications
Measured: 1 month
Late Reoperation Rate
The ratio of patient who need reoperation because residual adenoma or complications
Measured: 12 months
Post-TURP Syndrome Rate
Post-transurethral resection of the prostate syndrome rate was recorded.
Measured: Up to 24 hours
Clavien Dindo System
It is a system for evaluating surgical complications at 12 months after surgery.
Clavien I
- Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions.
- Acceptable therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes, and physiotherapy.
Clavien II
- Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
- Blood transfusions and total parenteral nutrition are also included
Clavien III
- Requiring surgical, endoscopic or radiological intervention
Clavien IV - Life-threatening complication (including central nervous system complications) requiring intensive care unit management
Clavien V
- Death of a patient
Measured: 12 months
Bleeding Complications Rate
Register the number of events of haematuria and acute urinary retention by clots
Measured: 1 month
Urinary Tract Infections Rate
Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.
Measured: 12 months
Stenotic Complications Rate: Meatal Stenosis
Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.
Measured: 12 months
Stenotic Complications Rate: Urethral Stricture
Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.
Measured: 12 months
Stenotic Complications Rate: Bladder Neck Contracture
Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.
Measured: 12 months
Stress Urinary Incontinence Rate
Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery.
Measured: 12 months
Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate
Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery.
Measured: 12 months
Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate
Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery.
Measured: 12 months
Sequelae Rate: Retrograde Ejaculation
register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.
Measured: 12 months
Sequelae Rate: Dysuria
register the number of dysuria at 1, 3, 6, and 12 after surgery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start5 Dec 2014
- Primary completion12 Dec 2017
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Fuenlabrada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Alonso, Hospital Universitario de Fuenlabrada
- Investigators
- Manuel Álvarez Ardura, M.D., Principal investigator, Hospital Universitario de FuenlabradaHugo Otaola Arca, M.D., Ph.D., Principal investigator, Hospital Universitario de FuenlabradaÁlvaro Páez Borda, M.D., Ph.D., Study chair, Hospital Universitario de Fuenlabrada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936244
- Sponsor's protocol ID
- HUF
- Status last verified
- Oct 2020
- First submitted
- 24 Apr 2019
- Last updated
- 12 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ahyai SA, Gilling P, Kaplan SA, Kuntz RM, Madersbacher S, Montorsi F, Speakman MJ, Stief CG. Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement. Eur Urol. 2010 Sep;58(3):384-97. doi: 10.1016/j.eururo.2010.06.005. Epub 2010 Jun 11.
PubMed 20825758Cornu 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 24972732Otaola-Arca H, Alvarez-Ardura M, Molina-Escudero R, Fernandez MI, Paez-Borda A. A prospective randomized study comparing bipolar plasmakinetic transurethral resection of the prostate and monopolar transurethral resection of the prostate for the treatment of Benign Prostatic Hyperplasia: efficacy, sexual function, Quality of Life, and complications. Int Braz J Urol. 2021 Jan-Feb;47(1):131-144. doi: 10.1590/S1677-5538.IBJU.2019.0766.
PubMed 33047918
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Bipolar Plasmakinetic Transurethral Resection of the Prostate With Monopolar Transurethral Resection of the Prostate in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT03936244
- Acronym / sponsor ID
- HUF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Universitario de FuenlabradaUniversity, hospital or other
- Study start
- 5 Dec 2014 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution
Detailed description
The study is a randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes (efficacy, complications and sequelae) for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution (Madrid, Spain)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-TURP | Active comparator | Device: Transurethral Resection of the Prostate (TURP)The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator |
| PK-TURP | Experimental | Device: Transurethral Resection of the Prostate (TURP)The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Sign the informed consent voluntarily and will be willing to follow-up
- Prostate volume <80 g
- Meet any conditions (1) Diagnose of LUTS due to refractory to drugs BPH. (2) presenting complications derived from BPH (bladder calculi, recurrent haematuria, recurrent urinary tract infections, acute urinary retention)
- The use of antiplatelet agents or anticoagulant drugs is allowed.
Key exclusion criteria (6 listed)
- Previous history of pelvic surgery
- Previous history of pelvic radiotherapy
- Previous history of neurogenic bladder dysfunction
- Documented or suspected prostate carcinoma
- Patients with severe cardiopulmonary disease or severe mental disorders
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 |
|---|---|---|
| Transurethral Resection of the Prostate (TURP)Randomized allocation to M-TURP or PK-TURP | Device | M-TURP, PK-TURP |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: 12 months
International Prostate Symptom Score (with 7 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows categorizing the lower urinary tract symptoms (LUTS) in 3 categories * Mild LUTS: 0-7 points * Moderate LUTS: 8-19 points * Severe LUTS: 20-35 points
Maximum Urinary Flow Rate (Qmax
Time frame: 12 months
Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.
Postvoid Residual Urine (PVRU) Volume
Time frame: 12 months
Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery.
28 secondary outcomes
Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire
Time frame: 12 months
Number of Participants Reporting Sexual Activity in the Last Month
Time frame: 12 months
International Index of Erectile Function (IIEF-5)
Time frame: 12 months
Prostate Volume (PV)
Time frame: 12 months
Operative Time
Time frame: Up to 24 hours
Irrigation Volume
Time frame: Up to 24 hours
Change in Plasmatic Sodium in 24 Hours Post-operation
Time frame: 24 hours after surgery
Change in Haemoglobin in 24 Hours Post-operation
Time frame: 24 hours after surgery
Transfusion Rate
Time frame: 1 month
Catheter Duration
Time frame: 1 month
Hospital Stay
Time frame: 1 month
Resected Tissue Weigh
Time frame: Up to 24 hours
Resected Tissue Percentage
Time frame: Up to 24 hours
Speed Resection
Time frame: Up to 24 hours
Early Reoperation Rate
Time frame: 1 month
Late Reoperation Rate
Time frame: 12 months
Post-TURP Syndrome Rate
Time frame: Up to 24 hours
Clavien Dindo System
Time frame: 12 months
Bleeding Complications Rate
Time frame: 1 month
Urinary Tract Infections Rate
Time frame: 12 months
Stenotic Complications Rate: Meatal Stenosis
Time frame: 12 months
Stenotic Complications Rate: Urethral Stricture
Time frame: 12 months
Stenotic Complications Rate: Bladder Neck Contracture
Time frame: 12 months
Stress Urinary Incontinence Rate
Time frame: 12 months
Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate
Time frame: 12 months
Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate
Time frame: 12 months
Sequelae Rate: Retrograde Ejaculation
Time frame: 12 months
Sequelae Rate: Dysuria
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20825758Ahyai SA, Gilling P, Kaplan SA, Kuntz RM, Madersbacher S, Montorsi F, Speakman MJ, Stief CG. Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement. Eur Urol. 2010 Sep;58(3):384-97. doi: 10.1016/j.eururo.2010.06.005. Epub 2010 Jun 11.
- 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.
- Results publication: PubMed 33047918Otaola-Arca H, Alvarez-Ardura M, Molina-Escudero R, Fernandez MI, Paez-Borda A. A prospective randomized study comparing bipolar plasmakinetic transurethral resection of the prostate and monopolar transurethral resection of the prostate for the treatment of Benign Prostatic Hyperplasia: efficacy, sexual function, Quality of Life, and complications. Int Braz J Urol. 2021 Jan-Feb;47(1):131-144. doi: 10.1590/S1677-5538.IBJU.2019.0766.
- Individual participant dataSharing planned: No
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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.
Manuel Álvarez Ardura, M.D. principal investigator
Hospital Universitario de Fuenlabrada
Hugo Otaola Arca, M.D., Ph.D. principal investigator
Hospital Universitario de Fuenlabrada
Álvaro Páez Borda, M.D., Ph.D. study chair
Hospital Universitario de Fuenlabrada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral Resection of the Prostate (TURP) in people with Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Hospital Universitario de Fuenlabrada at 1 site in Spain.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 12 Nov 2020. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
International Prostate Symptom Score (IPSS) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT03936244, which also lists 3 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 12 Nov 2020.