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

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH); Urological and Genital Diseases; Hyperplasia of prostate

• Registration Number: ISRCTN16583435
• Lead Sponsor: Academic Medical Center (AMC), Department of Urology (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 94

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Safety bipolar TURP compared with monoploar TURP by means of transurethral resection (TUR) syndrome<br>2. Blood loss<br>3. Number and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
1. Efficacy of bipolar TURP compared with monopolar TURP by means of IPSS or quality of life (QoL) scores<br>2. International index of erectile function (IIEF) score<br>3. Qmax<br>4. Cutting rate<br>5. Length of catherisation<br>6. Length of hospital stay<br>7. Length of operation<br>8. Impact on prostate specific antigen (PSA) level<br>9. Number of strictures