Benign Prostatic Hyperplasia Clinical Trial
Official title:
Bipolar Transurethral Enucleation (BipolEP) vs Bipolar Transurethral Resection of the Prostate: A Prospective Interventional Multi-center Randomized Controlled Trial
The aim of this study is to compare two different surgical methods for treating benign
prostatic obstruction (BPO).
The investigators are going to compare the risks and benefits of bipolar transurethral
resection of the prostate (TURP) and bipolar transurethral enucleation of the prostate
(BipolEP). Furthermore, the investigators are going to compare the amount of tissue resected
per minute, in order to assess the efficiency of each surgical method.
It is a prospective, interventional, multi-centre (2 centres total), randomized trial.
Approximately 84 patients will be included
Overview:
The aim of this study is to compare two different surgical methods for treating benign
prostatic obstruction (BPO).
The investigators are going to compare the risks and benefits of bipolar transurethral
resection of the prostate (TURP) and bipolar transurethral enucleation of the prostate
(BipolEP). Furthermore, the investigators are going to compare the amount of tissue resected
per minute, in order to assess the efficiency of each surgical method.
All patients will be followed up for 12 months. All the examinations used to assess the risks
and benefits of BipolEP and TURP are listed below:
- Dysuria visual analogue scale (at 1 month)
- I-PSS (international prostate symptom score), QOL (quality of life), Qmax (maximum flow
rate of urine) and PVR (post void residual bladder volume) before surgery and at 1, 4
and 12 months
- IIEF-15 (international index of erectile function) and PSA (prostate specific antigen)
(before surgery and at 4 and 12 months)
- TRUS (transrectal ultrasonography) for prostate size before surgery and at 4 months
It is a prospective, interventional, multi-centre (2 centres total), randomized trial.
Approximately 84 patients will be included in this study. Each patient will be randomly
assigned either to the BipolEP or to the TURP study arm. For the allocation of treatment to
subjects the minimization method will be used (Strata: 1. prostate 60 to 80 ml / more than 80
ml; 2. catheterized / non-catheterized). The minimization procedure will be applied centrally
(by the coordinating centre).
Statistical analysis plan :
Concept
The study is designed as a comparison of two kinds of treatment:
Group BipolEP: Bipolar transurethral enucleation of the prostate Group TURP: Bipolar
transurethral resection of the prostate
Two primary endpoints are chosen:
1. : IPSS after 12 month [-]
2. : Tissue resection [g/min]
The use of a gate keeping approach makes it unnecessary to adjust the type I error. Primary
endpoint (1) will be investigated by a non-inferiority approach (type I error = 5%
one-sided), primary endpoint (2) by a superiority approach (type I error = 2.5% one-sided).
Hypotheses:
1. : H-01: Compared to group TURP, IPSS after 12months in group BipolEP is higher
(non-inferiority range = 3) H-11: Compared to group TURP, IPSS after 12months in group
BipolEP is not higher (non-inferiority range = 3)
2. : H-02: Compared to group TURP, tissue resection in group BipolEP is not increased H-12:
Compared to group TURP, tissue resection in group BipolEP is increased
Statistical Methods:
Group Comparisons:
Primary Endpoint (1):
Data (if appropriate, in logarithmised version) will be checked for normal distribution
(Kolmogorov-Smirnov with Lilliefors significance correction, type I error = 10%). Hypotheses
(H-01, H-11) will be investigated either by a parametric or by a non-parametric one-sided
test of equivalence (equivalence range one-sided = 3; type I error = 5% one-sided).
Primary Endpoint (2):
Data (if appropriate, in logarithmised version) will be checked for normal distribution
(Kolmogorov-Smirnov with Lilliefors significance correction, type I error = 10%). Hypotheses
will be investigated either by the t-test for independent samples or by the Mann-Whitney
U-test (type I error = 2.5% one-sided). Hypotheses (H-02, H-12) will be tested only if H-01
hypothesis is rejected.
Further Variables:
All other variables will be analysed by usual parametric and non-parametric tests for
univariate comparisons of independent samples.
Two-sided 95% confidence intervals:
For selected variables, two-sided 95% confidence intervals will be calculated.
Type I error adjustment:
No adjustment for the type I error will be made. Therefore - apart from hypotheses testing -
the results of inferential statistics will be descriptive only.
Sample size assessment:
The following scenario was used for the sample size estimation concerning primary endpoint
(1):
- Non-inferiority range = 3
- Type I error = 5% one-sided
- Type II error = 10%
- IPSS after 12 months in both groups (Mw ± SD) = 4 ± 4
- n (group BipolEP) / n (group TURP) = 1 / 1
- Parametric test The result of the sample size estimation is a requirement of 31 cases
per group. Assuming a drop-out rate of 20% and considering the possible need for a
non-parametric test a total of 84 inclusions (n=42 / group) are chosen as the sample
size of the study.
Data management and quality assurance:
In order to assure that the collected data are accurate, consistent, complete and reliable,
the primary investigator will review all the CRFs. If any data is missing, incomplete or
inaccurate, the medical record of the patient will be used to identify the missing data. If
the data notated in the medical record is missing or implausible, the data will be recorded
in the database as missing value. In the intention to treat population and only for the two
primary endpoints, the missing values will be replaced according to the worst-case principle
(use of the worst assessed value in the study).
After all the CRFs have been checked for completeness and accuracy, the data will be entered
in a special database. A second person, involved in the study, will check all the data
entered. Once the database is complete and has been checked, it will be locked, marking the
beginning of the statistical analysis. The data will be analyzed by a statistician.
The investigator will keep all source documents, CRFs and trial documentation. The
investigator will store all study documents and all mandatory documents linked to the study
including the identity of all patients (enough information to link the records, eg, the CRF
and hospital records), all original signed informed consent forms and copies of all CRD
(clinically relevant documents) for a minimum of 5 years. All study-linked documents will be
stored under strict security and will be available for review for authorized personnel only.
Adverse Event:
The Investigator and designated study personnel will monitor each subject for adverse events
during the study. All adverse events reported between consent and final follow-up will be
recorded in the case report form (CRF). The investigator or designee will ask the subject
non-leading questions in an effort to detect adverse events. The intra- and postoperative
adverse events will be quantified according to the Clavien-Dindo classification. In case of
any adverse event or change of treatment, the primary investigator has to be informed.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04807296 -
Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)
|
N/A | |
Recruiting |
NCT05574244 -
Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
|
N/A | |
Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
Not yet recruiting |
NCT04245566 -
Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
|
Phase 3 | |
Completed |
NCT03246880 -
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
|
Phase 3 | |
Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
Completed |
NCT02509975 -
Safety and Efficacy of OCL 503 in Prostate Artery Embolization
|
N/A | |
Completed |
NCT02206243 -
Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
|
||
Completed |
NCT02283684 -
GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT
|
Phase 4 | |
Completed |
NCT01454349 -
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 1/Phase 2 | |
Completed |
NCT01438775 -
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
|
Phase 3 | |
Completed |
NCT01152190 -
A Study in Benign Prostatic Hyperplasia
|
Phase 3 | |
Completed |
NCT01139762 -
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
|
Phase 3 | |
Active, not recruiting |
NCT00400894 -
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
|
N/A | |
Unknown status |
NCT00381108 -
Study of the Effects of Pomegranate Tablets on Enlarged Prostates
|
Phase 1 | |
Completed |
NCT00224133 -
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
|
Phase 3 | |
Completed |
NCT00701779 -
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
|
Phase 4 | |
Terminated |
NCT02962674 -
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
|
N/A | |
Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
Recruiting |
NCT04853914 -
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
|
N/A |