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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20354

Enrollment

Registered

2006-08-07

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Benign prostatic hyperplasia

Interventions

Transrectal intraprostatic injection with botulinum toxin type A

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 55 2. Signed informed consent 3. LUTS with IPSS (international prostatic symptom score) > 7 4. Insufficient respons to oral medication 5. Prostatic volume 30-50 ml 6. Urodynamic infravesical obstruction > 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

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

Design outcomes

Primary

Measure	Time frame
Symptom relief according to the International Prostatic Symptom Score(IPSS)	—

Secondary

Measure	Time frame
1. Urodynamic obstruction (according to Schafer) 2. Post void residual 3. Decrease in prostate volume 4. Histologic change after 1 month 5. PSA change 6. Other treatment needed	—

Contacts

Public ContactL.M.O. Kort, de

University Medical Center Utrecht (UMCU), P.O. Box 85500

l.m.o.dekort@umcutrecht.nl+31 (0)30 2508079

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)