Clinical and histologic effect of transrectal intraprostatic injections with botulinum toxin A in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia

Completed

• Conditions: Benign prostatic hyperplasia; Urological and Genital Diseases; Diseases of male genital organs

• Registration Number: ISRCTN42633050
• Lead Sponsor: niversity Medical Center Utrecht (UMCU) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Age more than 55
2. Signed informed consent
3. Lower Urinary Tract Symptoms (LUTS) with International Prostatic Symptom Score (IPSS) more than seven
4. Insufficient response to oral medication
5. Prostatic volume 30 to 50 ml
6. Urodynamic infravesical obstruction more than grade II according to Schafer
7. Willing and able to fill out questionnaires and voiding diaries
8. Willing and able to attend proposed investigations

Exclusion Criteria

1. Neuropathic bladder dysfunction
2. Prostatic carcinoma
3. Coagulation disorder
4. Urinary tract infection
5. Bladder calculus
6. Post-renal renal insufficiency
7. Myopathic disorder
8. Anatomical defects preventing transrectal approach

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom relief according to the International Prostatic Symptom Score (IPSS).

Secondary Outcome Measures

Name	Time	Method
1. Urodynamic obstruction (according to Schafer) <br>2. Post-void residual <br>3. Decrease in prostate volume <br>4. Histologic change after one month<br>5. Prostate Specific Antigen change <br>6. Other treatment needed