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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30514

Enrollment

Registered

2007-05-01

Start date

2007-05-09

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign prostatic hyperplasia prostatic enlargement

Interventions

Transrectal injection of botulinum toxin type A into the prostate.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: lower urinary tract symptoms IPSS (international prostatic symptom score) > 7 prostatic volume 30-50 ml urodynamic infravesical obstruction > grade II according to Schafer

Exclusion criteria

Exclusion criteria: neuropathic bladder dysfunction prostatic carcinoma coagulation disorder

Design outcomes

Primary

Measure	Time frame
Symptom relief (IPSS). Urodynamic obstruction (according to Schafer) Histologic changes after 1 month	—

Secondary

Measure	Time frame
Post void residual Decrease of prostate volume Change in PSA Other treatment needed	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)