Phase 3
N=30
Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT01220726 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Urinary Frequency — 10.5; 11; 12; 8.5 urinations
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botox (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Frequency |
10.5; 11; 12; 8.5; 12; 8 | — |
| PRIMARY Urgency |
4.5; 2; 0.5; 1; 0; 0 | — |
| PRIMARY Quality of Life (QoL) |
90; 73; 97.5; 81.5; 92; 82.5 | — |
| PRIMARY International Consultation on Incontinence Questionnaire (ICIQ) |
7; 9; 5; 8; 4.5; 7 | — |
| PRIMARY Postvoid Residual Volume (PVR) |
34.8; 36; 41.7; 137.1; 26.3; 73.1 | — |
| PRIMARY Maximum Flow Rate (Qmax) |
16.0; 21.1; 14; 15.7; 12.7; 16.5 | — |
| PRIMARY International Prostate Symptom Score (IPSS) |
20; 16; 13.5; 15.5; 13; 15 | — |
Summary
This is a prospective, randomized, double-blind study comparing intravesical injection of BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following treatment groups:
Eligibility Criteria
Inclusion Criteria
- Male outpatients of any race, between 40 and 90 years of age.
- Clinical signs and symptoms of frequency (>=8 micturitions/day) and urgency (>=2 episodes/day).
- Urodynamic history consistent with OAB that developed in conjunction with BPO and that persists for at least 3 months post TURP or PVP, RRP or other obstruction relieving procedure.
- OAB inadequately controlled with anticholinergic medications, as per Investigator opinion.
- Qmax >12mL/s with a voided volume of >125mL.
- IPSS >12, with IPSS QoL >3 at study Visit 1.
- Willing to use clean intermittent catheterization (CIC) to empty the bladder or is willing to have an indwelling catheter, if necessary following study treatment.
- Able to understand the requirements of the study, including completing questionnaires and signing Informed Consent/HIPAA.
Exclusion Criteria
- 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.
- Known history of clinically significant cardiovascular disease, cerebrovascular disease, or arrhythmia.
- History of spinal cord injury or multiple sclerosis, or other neurological disease which may be contributing to OAB.
- Known history of hydronephrosis.
- Current indwelling catheter, or removal of chronic catheter 10ng/mL.
- 24 hour total volume voided >3000 mL of urine. [As determined by completion of a patient bladder diary during the screening period]
- 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.
- Allergy or sensitivity to any component of BOTOX® (Section 5.2).
- Known uncontrolled systemic disease.
- Evidence of recent alcohol/drug abuse.
- Subjects who, in the opinion of the Investigator, have a significant condition that puts them at significant risk, may confound study results, or interfere with study participation.
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
Data sourced from ClinicalTrials.gov (NCT01220726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.