Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain

Objective:

Primary objective: To evaluate the change in patient-reported pelvic pain following pelvic
floor injections of 200 units of Botox compared with 20cc of normal saline.

Secondary objective: To evaluate the change in patient-reported pelvic pain following Botox
injections in conjunction with pelvic floor physical therapy compared to saline injections
with physical therapy.

Hypothesis We hypothesize that women in the Botox treatment arm, compared with those in the
saline arm, will have a greater decrease in patient-reported pain on palpation of their most
painful levator ani muscle group at two weeks after the injection.

To test this hypothesis we will measure patient-reported pain on palpation of each levator
ani muscle group at baseline and two weeks following the injection. Pain will be assessed on
a 10-point visual analog scale. We will compare the baseline and two-week pain measurements
for the most painful muscle group.

We hypothesize that with the addition of physical therapy, women in the Botox treatment arm,
compared with those in the saline arm, have a greater decrease in patient-reported pain on
palpation of their most painful levator ani muscle group at 12 weeks after the injection.

To test this hypothesis we will measure patient-reported pain on palpation of each levator
ani muscle group at baseline and 12 weeks following the injection. Pain will be assessed on a
10-point visual analog scale. We will compare the baseline and 12-week pain measurements for
the most painful muscle group.

Intervention:

All patients will be screened for eligibility during their routine office visit. If they meet
all eligibility criteria, they will be offered enrollment. At this visit, all patients will
be counseled about conservative treatment options for dealing with irritative voiding
symptoms, bowel symptoms, and pain. The counseling offered will be standardized for all
patients. After patients are consented, they will undergo an initial evaluation with a pelvic
floor physical therapist. Patients will then return for an office visit to receive their
treatment. The patients will be pretreated with 100mg of topical Lidocaine hydrochloride
jelly, 2%, in the vagina for 15 minutes prior to their injections. A designated medical
assistant will open an opaque sealed envelope to determine whether the patient is randomized
to the Botox or saline arm. The medical assistant will draw up the appropriate
solution—either 20mL of saline or 200 units of Botox A diluted in preservative-free saline,
to achieve a concentration of 10 units per mL. Both the Botox and saline will be drawn into 2
unlabeled 10mL syringes in order to ensure the physician remains blinded to treatment arm
assignment. The saline or Botox will be injected to the coccygeus, piriformis, obturator
internus, puborectalis, iliococcygeus, and pubococcygeus muscles bilaterally for a total of
1-2mL per muscle group. Using digital vaginal palpation, the muscles to be injected will be
located with care taken to locate tender and contracted points on the muscle fibers. The
index finger is used for palpation as the 20-gauge pudendal block needle with the guide is
advanced to the target site piercing through the vaginal mucosa to the intended muscle
groups. The needle is placed into the intended muscles under direct palpation for injection
of 1-2mL aliquots.

Study Design:

This is a double-blinded, randomized controlled trial. Participants will be randomized to
either Botox or saline in a ratio of 1:1 using computer-generated block randomization. The
statistician will create the sequentially numbered opaque sealed envelopes to conceal group
assignment.Study visits Baseline visit Once determined eligible, patients will be offered
enrollment into the study. After consent forms are signed, we will obtain study data.
Participants will then see a physical therapist at a designated pelvic floor physical therapy
center to evaluate their pelvic floor prior to any intervention.

Injection visit Following the pelvic floor physical therapy assessment, participants will
return to the urogynecology office for their injection of saline or Botox as specified above.

Two-week post-injection visit At two weeks, patients will return for outcome assessments.
Four-week post-injection visit Patients will return at 4 weeks for the same outcome
assessment they had at 2 weeks. After the 4-week visit, participants will start pelvic floor
physical therapy. They will go to physical therapy for a total of 8 sessions, done as close
to weekly as possible.

Twelve-week post-injection visit At 12 weeks patients will return for outcome assessments.
After all outcome data are collected, the provider and the patient will be unblinded.
Patients who were randomized to the placebo group will be offered 200 Units of Botox
injection at no cost. These 32 patients will be encouraged to continue with weekly physical
therapy for 8 weeks following the Botox injection. We will ask these participants to return
at 2 weeks and 12 weeks after the injection for outcome assessments. During these visits we
will collect the same data as for the 2-week and 12-week visits.

Inclusion Criteria:

- Age greater than 18

- Diagnosis of myofascial pain by an attending urogynecologist

- Persistent pelvic pain present for ≥50% of days over the past 3 months at a level of 6
or greater on a 10-point visual analog scale

- On physical exam, a short, tight pelvic floor with pain on palpation of at least 6 on
a 10-point visual analog scale in at least one muscle group (coccygeus, pyriformis,
obturator internus, iliococcygeus, puborectalis, or pubococcygeus).

- Ability to read English, provide written, informed consent and be able and willing to
go to pelvic floor physical therapy.

Exclusion Criteria:

- Pregnancy or breastfeeding

- Any of the following a pre-existing neurologic or neuromuscular condition that
precludes them from Botox injections, such as myasthenia gravis, a bleeding disorder;
or sensitivity or allergy to Botox

- Current use of aminoglycosides or any other medication that may potentiate the
neuromuscular weakness that could be caused by concomitant use of Botox also will be
ineligible

- History of treatment with Botox to the pelvic floor

- Presence of any masses or lesions on physical exam

- Pelvic organ prolapse greater than stage 2

- Plan for pelvic floor surgery or pelvic floor physical therapy treatment in the next
three months

- Change in pain medication usage in the past 3 months