Effect of 50 and 100 IU Doses of Botox A Toxin Injection in BPH Patients.

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of this study is to compare the efficacy and safety of a single injection of 50 U and 100 U doses of BoNT-A for the treatment of BPH-associated LUTS.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beni-Suef University
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• persistent moderate to severe LUTS as determined by International Prostatic Symptom Score (IPSS) >8.

• peak urinary flow rate of less than 12 mL/s.

• an enlarged prostate gland on digital rectal examination.

Exclusion Criteria:

• history of previous surgery for BPH.

• presence of urethral stenosis.

• urinary tract infection.

• prostate or bladder cancer.

• history of pelvic surgery or radiotherapy.

• neurological diseases.

• urinary retention.

• BPH-associated complications requiring surgical treatment including bladder stone, and bilateral hydronephrosis.