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

The standard treatment of lower urinary tract symptoms due to benign prostatic
hyperplasia, not responding to medication, is transurehtral prostatic reection.
This is an invasive procedure requiring general or regional anestesia.
Intraprostatic injection of botulinum toxin tyope A (Botox) causes relaxation
of smooth muscle tissue and causes cellular apoptosis. Therefor it is possibly
effective for treatment of benign prostatic hyperplasia. Transrectal prostatic
injection is minimally invasive and can be performed without anestesia in the
outpatient clinic.

To determine the effect on lower urinary tract symptoms and to determine
urodynamic and histologic changes after intraprostatic botulinum toxin type A
injection.

Prospective uncontrolled monocenter pilot study.

Transrectal injection of botulinum toxin type A into the prostate.

At least 8 visits to the outpatient clinic are necessary. Four urodynamic
studies will be performed (in total 4 hours). Patients will be asked to fill
out questionnaires and voiding diaries with every visit.
There is a risk for prostatitis and a risk for hemorrage due to the prostatic
biopsy and after the intraprostatic injection. Furthermore there is a risk for
side effects of the botulinum toxin like allergy (infrequently), aritmia and
respiratory problems in case of overdose.