Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OnabotulinumtoxinA · 1 trial · 3 indications
a 30% reduction of pain and muscular spasm assessed by visual analog scale - VAS
| Arm | Type | Description |
|---|---|---|
| Treatment Group | ACTIVE_COMPARATOR | 20 patients randomly assigned to receive 100 U onabotulinumtoxinA reconstituted in 20 ml saline sequentially injected bilaterally into the pubococcygeus, iliococcygeus, coccygeus, obturator internus, and piriformis muscles. |
| Placebo group | PLACEBO_COMPARATOR | 20 patients randomly assigned to receive 20 ml of saline bilaterally into the same pelvic floor muscles. |
| Name | Type | Description |
|---|---|---|
| OnabotulinumtoxinA | DRUG | comparison of OnabotulinumtoxinA with placebo |
| Placebo | DRUG | comparison of placebo with investigational drug OnabotulinumtoxinA |
Inclusion Criteria: 1. Females age 18 years to 65 years 2. MPP for at least 6 months with pain ranked \> 7/10 by VAS 3. Able to make medical decisions for herself 4. Ability to speak and understand English 5. Ability to follow study instructions and likely to complete all required visits 6 .Must gi...