A prospective, randomised, double-blinded study to compare bipolar transurethral resection of the prostate (bipolar TURP) versus monopolar transurethral resection of the prostate (monopolar TURP) in terms of safety and efficacy

ISRCTN	ISRCTN16583435
DOI	https://doi.org/10.1186/ISRCTN16583435
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr S.A. Lagerveld-Zaaijer
Scientific

Academic Medical Center (AMC)
Department of Urology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5666030
Email	S.A.Zaaijer@amc.uva.nl

Study design	A prospective, randomised, double-blinded study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	TURP
Study objectives	Bipolar devices will minimise the disadvantages of the monopolar device such as the risk of electrolyte disturbances by using saline irrigation, bleeding and the risk of nervous stimulation.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Benign Prostatic Hyperplasia (BPH)
Intervention	Patients will be randomised into either: Group A: who will undergo a bipolar TURP Group B: who will undergo a monopolar TURP
Intervention type	Other
Primary outcome measure	1. Safety bipolar TURP compared with monoploar TURP by means of transurethral resection (TUR) syndrome 2. Blood loss 3. Number and severity of adverse events
Secondary outcome measures	1. Efficacy of bipolar TURP compared with monopolar TURP by means of IPSS or quality of life (QoL) scores 2. International index of erectile function (IIEF) score 3. Qmax 4. Cutting rate 5. Length of catherisation 6. Length of hospital stay 7. Length of operation 8. Impact on prostate specific antigen (PSA) level 9. Number of strictures
Overall study start date	01/07/2006
Completion date	31/12/2010

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	94
Key inclusion criteria	1. Candidates for transurethral resection of the prostate (TURP) 2. Qmax less than 16 ml/sec 3. International Prostate Symptom Score (IPSS) score greater than 14 4. Voided volume greater than 125 5. Patients in retention with an indwelling catheter or intermittent catheterisation 6. Informed consent
Key exclusion criteria	1. If patient is suspected to be suffering from prostate cancer 2. Prior prostate surgery, including minimal invasive therapies 3. Active urinary tract infection 4. Known or suspected neurogenic decompensated bladder (postvoid residual urine volume [PVR] greater than 400ml/sec) or compensated detrusor function 5. Immunosuppression; using prednisone 6. Known or suspected malignant disease affecting the bladder or lower urinary tract 7. 5-alpha-reductase inhibitor within the last three months before baseline 8. Alpha-blockers within the last six weeks before baseline 9. Specific severe heart disease in whom anti-coagulant therapy might jeopardize treatment outcome
Date of first enrolment	01/07/2006
Date of final enrolment	31/12/2010

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Academic Medical Center (AMC), Department of Urology (The Netherlands)
University/education

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

"ROR"	https://ror.org/03t4gr691

Industry

Karl Storz (UK)

No information available

Academic Medical Center (AMC) (The Netherlands) - Department of Urology

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan