Recruiting
Phase 2
Phase 3

Botox

Sponsor:

Urological Sciences Research Foundation

Code:

NCT00479596

Conditions

Overactive Bladder

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Botox

Study Details

Brief summary:

The current study will investigate the comparative efficacy, safety and patient satisfaction of intradetrusor injections BOTOX® injections (200U) versus placebo (saline) injections in the treatment of OAB secondary to benign prostatic obstruction (BPO).

Conditions

Overactive Bladder

Study ID

NCT00479596

Start date

Jan, 2007

Status verified date

Jan, 2007

Completion date

May, 2007

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male between 40 and 90 years of age.
2. Clinical signs and symptoms of frequency and urgency
3. Urodynamic history consistent with OAB that developed in conjunction with Benign Prostate Obstruction and that persists for at least 3 months post TURP or PVP, or other obstruction relieving procedure.
4. OAB inadequately controlled with anticholinergic medications
5. Qmax >12mL/s with a voided volume of >125mL.
6. IPSS >12, with IPSS QoL >3 at study Visit 1.
7. Willing to use clean intermittent catheterization (CIC) to empty the bladder or is willing to have an indwelling catheter, if necessary following study treatment.

Exclusion Criteria:

1. Known history of interstitial cystitis, uninvestigated hematuria, bladder outlet obstruction due to vesical neck contracture, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
2. Current indwelling catheter, or removal of chronic catheter <1 month prior to study entry.
3. Non-compliance with wash-out periods for prohibited medications/therapies
4. Evidence of Urinary Tract Infection according to local standard of care.
5. History of prostate cancer.
6. Serum PSA of >10ng/mL. \[NOTE: Subjects with serum PSA concentrations >4 and <10 must have prostate cancer excluded according to the local standard of care.\]
7. 24 hour total volume voided >3000 mL of urine
8. Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
9. Allergy or sensitivity to any component of BOTOX®

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Botox

Primary outcome measure

  • Safety and efficacy of BOTOX to placebo (saline) in the treatment of OAB secondary to BPO. [ Time Frame: 6 months post injection ]

Central Contacts and Locations

Central contacts

Locations

Urological Sciences Research Foundation

Recruiting

Culver City, California, United States, 90232

Contacts

Principal Investigator:

Leonard S Marks, M.D.

More Information

Sponsor

Urological Sciences Research Foundation

Last update posted

May 30, 2007

Last verified

Jan, 2007

Keywords

  • Overactive Bladder
  • OAB
  • Refractory OAB
  • Botox
  • Bladder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Urological Sciences Research Foundation on 2007-05-30.