The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transrectal Ultrasound-guided (TRUS) Prostate Biopsy
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the therapeutic efficacy of tamsulosin and tadalafil compared to placebo in the treatment and prevention of urinary disorders after transrectal ultrasound-guided (TRUS) prostate biopsy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
After being informed about the clinical study and all the risks, all patients will be given a written informed consent. They will be randomised in three groups: A (tadalafil),B (tamsulosin) and C (placebo) and the drug or placebo will be administrated seven days before and seven days after TRUS prostate biopsy. Before the biopsy, all patients will receive the prophylactic antibiotic ciprofloxacin 500 mg, which they will continue to drink twice a day for another three days after the procedure. Before the biopsy patients will do an uroflowmetry to determine the Qmax and ultrasound(US) of the urinary tract to determine residual urine. After the biopsy is performed the patient fills out the international prostate symptom score (IPSS/QoL), visual analog scale (VAS) for pain, International Index of Erectile Function (IIEF-5) and 36-Item Short Form Survey (SF-36) questionnaires. Seven days after the biopsy the patient discontinues with the therapy and makes a visit for routine control of uroflowmetry, US of the urinary tract, basic laboratory (CBC and CRP) and he previously mentioned questionnaires are filled out. After 30 days of the biopsy the patient makes a visit for regular control of the pathohistological findings, uroflowmetry and ultrasound of the urinary tract, along with filling out the questionnaires again.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Tadalafil
|
Drug: Tadalafil 5mg
Administration of Tadalafil 5mg once daily seven days before and seven days after prostate biopsy
|
| Active Comparator: Tamsulosin
|
Drug: Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule
Administration of Tamsulosin 0.4mg once daily seven days before and seven days after prostate biopsy
|
| Placebo Comparator: Placebo
|
Other: Placebo
Administration of placebo ( Vitamin C [ascorbic acid] 500mg tablet) once daily seven days before and seven days after prostate biopsy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Visual analog scale for pain (VAS) [Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy]
Visual analog scale is a simple scale that rates pain form zero to ten, where zero is rated as no pain and ten is rated as unbearable pain. The patient fills it by putting an X on the lane, where no pain, mild and moderate pain is on the left side of the line and severe, very severe and worst pain possible is on the right side of the line.
- Change in International prostate symptom score ( IPSS/QoL) [Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy]
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. There is also a separate question regarding quality of life.
Secondary Outcome Measures
- Change in The short form health survey - SF-36 [Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy]
SF -36 measure eight dimensions of quality of life: physical functioning (10 items), role limitation due to physical problems (4 items), bodily pain (2 items), social functioning (2 items), mental health (5 items), role limitation due to emotional problems (3 items), vitality (4 items) and general health perception (5 items). Each dimension has a possible score of 0 (poor health) to 100 (excellent health)
- Change in The International Index of Erectile Function (IIEF-5) Questionnaire [Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy]
IIEF-5 is a validated questionnaire for erectile function. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Based on equal misclassification rates of erectile disfunction (ED) and no ED, a cutoff score of 21 (range of scores, 5-25) discriminated best. ED was classified into five severity levels, ranging from none (22-25) through severe (5-7). Substantial agreement existed between the predicted and 'true' ED classes. These data suggest that the IIEF-5 possesses favorable properties for detecting the presence and severity of ED.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Every patient that is a candidate for first time TRUS biopsy
Exclusion Criteria:
-
previous complaints of the lower urinary tract; benign prostatic hyperplasia(BPH), overactive bladder (OAB), etc.
-
previous urinary retention and catheterization
-
previous TRUS biopsies
-
patients who were treated surgically or medically for BPH
-
systemic diseases including uncontrolled diabetes
-
neurological diseases
-
hemorrhagic diathesis
-
patients on anticoagulants therapy
-
patients with urinary infections
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University hospital of Splity | Split | Splitsko-dalmatinska | Croatia | 21000 |
Sponsors and Collaborators
- University Hospital of Split
Investigators
- Principal Investigator: Ivo Juginović, University Hospital Split,Department of Urology
- Study Director: Marijan Šitum, University Hospital Split,Department of Urology
- Study Director: Sandro Glumac, University Hospital Split, Department of Anesthesiology and Intensive Care
- Study Chair: Mario Duvnjak, University Hospital Split,Department of Urology
- Study Chair: Marin Jelavić, University Hospital Split,Department of Urology
- Study Chair: Ruben Kovač, University Hospital Split, Department of Anesthesiology and Intensive Care
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UHSplit