OnabotulinumtoxinA Injections into Pelvic Floor Muscles under Electromyographic Guidance for Women with Refractory
High Tone Pelvic Floor Dysfunction: A 6-month prospective pilot study
Darlene Morrissey, Dominique El-Khawand, Natasha Ginzburg, Salim Wehbe, Peter O'Hare III, Gurdial Dhillon, Elizabeth Elias, Kristene Whitmore
Female Pelvic Medicine and Reconstructive Surgery
Drexel University College of Medicine & Pelvic and Sexual Health Institute, Philadelphia, PA
Results
Introduction
Baseline
Sexual Function
Received
Botox
Baseline
Included at 24
week point
Excluded
n=7
n=21
Withdrawn
n=3
16 sexually
active
Lost F/U
n=4
To determine the efficacy of EMG guided
injections into pelvic floor muscles in treating
pelvic pain and improving QoL in women with HTPFD.
Materials and Methods
•  Prospective, open-label, pilot
study between January 2011 and
August 2013
•  Inclusion criteria: Women ages
18-79 with refractory HTPFD
•  Exclusion criteria:
•  Previous Botox® use
•  Pelvic organ prolapse
repair
•  Implanted
neuromodulation device
•  Bleeding disorder or
current use of
anticoagulation
•  Hypersensitivity to Botox®
pre-existing neuromuscular
disorder
•  Infection at the injection
site (perineum)
•  Data was collected at baseline,
4, 8, 12, and 24 weeks after
injections.
Procedure*
Informed consent
Past medical history and Demographics
Eligibility criteria
Questionnaires** (VAS, ICSI/ICPI, PFDI-­‐20, FSDS, SF-­‐12 and GRA)
Adverse Events evaluation
Pelvic examination: PFM strength and tenderness (modified Oxford scale)
Perineometry
Concentric Needle EMG with local anesthetic
Botox® (up to 300 U)†
W0 W4
4 not active 2°
pain
X
X
W12
W24
X
X
X
X
X
X
X
X
X
X
X
X
Baseline characteristics*
1 no partner
Age
35.1(±9.1)
BMI
25(±4.4)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
* Follow-­‐up visits are in weeks after Botox® administration ** VAS: Visual analogue scales for pelvic pain and dyspareunia; ICSI/ICPI: Interstitial cystitis symptoms and problem indices; PFDI-­‐20: Pelvic floor distress inventory; FSDS: Female sexual distress scale; SF-­‐12: Short form-­‐12 health survey; GRA: Global response assessment † After transperineal concentric needle EMG localization of spastic PFM, Botox®is injected using the same needle. PFM included: pubococcygeus, ileococcygeus, coccygeus, obturator internus
Better Dyspareunia 9 8 7 6 5 4 3 2 1 0 2/21 (9.5%)
Comorbidities
Interstitial cystitis
9/21 (42.9%)
Vulvodynia
2/21 (66.7%)
Yes with pain
16/21 (72%)
No because of pain
14/21 (19%)
No because no partner
1/21 (4.8%)
10% no partner
4 40 Female Sexual Dysfunction (FSDS) 4 0.078
0.011
8 Weeks 0.0 30 60 24 0 p
0.081
0.005
4 8 Weeks 0 Visual analogue scale (0-10) for dyspareunia in women
who were sexually active
•
0.5 70 5 •
1.0 35 0.004
12 1.5 p
0.001
0.001
0.001
0.001
0 4 8 Weeks 12 24 0.006
0.001
12 24 •
*
50 40 30 20 Disclosures
10 0 0 4 Resting tone GRA I mprovement L evel 100% 8 Weeks Maximum contraction 12 24 Contraction gradiant 9 Physical (PCS) and Mental (MCS) Composite Scores 8 49 8 8 80% 7 7 7 6 6 50% 80.9 40% 80.9 80.9 61.9 Worsened 5 Same 4 Improved 3 4 3 2 4 8 Weeks 12 24 *7-point Likert scale from substantially worse to substantially improved
MCS (p<0.05) 37 0 0% PCS (p<0.05) 39 1 1 10% 43 41 2 2 20% 47 45 6 60% 30% Short Form-­‐12 9 Week 4 Slightly improved Week 8 Week 12 Moderately improved Week 24 Substantially improved 35 0 •
•
With these challenging patients, multiple treatment modalities are often crucial to improving
outcomes.
Botox® appears to have efficacy in this population.
Future studies, including a randomized controlled trial, are needed to better evaluate the role of
EMG-guided Botox® injection for high tone pelvic floor dysfunction.
*
* p<0.05 when compared to baseline
**Using a Peritron perineometer (Cadio Design, Australia)
Global Response A ssessment (GRA)* Our study aimed to expand on previous studies by providing more accurate and precise delivery of
onabotulinumtoxinA to the nidus of pelvic floor muscle trigger points.
Botox® injection into pelvic floor muscles of women with refractory HTPFD is beneficial up to 24
weeks by decreasing pain, improving sexual function, improving general quality of life, while
causing minimal side effects
Reported side effects post injection included:
•  Worsening of the following pre-existing conditions
•  Constipation (28.6%)
•  Stress Urinary Incontinence (4.8%)
•  Fecal Incontinence (4.8%)
•  De-Novo Stress Urinary Incontinence (4.8%)
This is the first study to look at EMG guided delivery of onabotulinumtoxinA to trigger points of the
pelvic floor muscles
Guiding placement of Botox using EMG can ensure accurate and precise placement of the toxin into
trigger points and muscles groups with elevated resting pressures.
Conclusion
80 10 0.059
2.0 Vaginal Pressure 15 p
•
2.5 24 20 0 *Displayed as mean (range), mean (±SD), fraction of the total number (%)
8 Weeks 12 25 70% 68.8 58.8 30% Same 83.3 80.0 0% 19/21 (90.5%)
African American
Worse 50% 20% 90% 60% 3 resumed
sexual activity
•
3.0 40% Sexual activity
W8
80% 90% 1 attempted but
stopped
Caucasian
Botox®
16 remained
active
•
Pelvic Floor Muscle Tenderness 70% 21
subjects
Race
Objective
At 24
weeks
100% Dyspareunia Digital Exam (0-­‐4 scale) n=28
Muscle Tone
Cm of water** •  High tone pelvic floor dysfunction (HTPFD) is a debilitating chronic pelvic pain (CPP) disorder with
significant impact on quality of life (QoL) and sexual function.
•  Treatment options include:
•  Physical therapy, muscle relaxants, pain medications, and/or trigger point injections with local
anesthetics
•  OnabotulinumtoxinA (Botox®):
•  Induces temporary muscle paralysis through presynaptic inhibition of acetylcholine release.
•  Off-Label use for HTPFD at this time.
•  Current research has focused on Botox® as a treatment for HTPFD:
•  A non-controlled study reported reduction in pain scores, decreased pelvic floor resting pressures,
increased tolerability of pelvic examination and intercourse, significant improvement of subjective
symptoms and QoL scores1
•  A recent randomized placebo-controlled study demonstrated improvement in dyspareunia, pelvic
pain and pelvic pressure but without significant difference from placebo group2 .
•  In patients with myofascial trigger points, an area of increased spontaneous electromyography (EMG)
activity exists in the 1-2mm surrounding the nidus of the trigger point 3 .
•  HYPOTHESIS:
•  We postulate that utilizing EMG readings will augment precise localization of high tone muscles
or pelvic floor trigger points ensuring an accurate delivery of Botox® to those muscles leading to
improvement in patient symptoms.
Discussion
4 8 Weeks 12 24 •  Darlene Morrissey, Natasha Ginzburg, Dominique El-Khawand, Salim Wehbe, Peter O'Hare III, Gurdial Dhillon. Nothing to
disclose
•  Kristene Whitmore: Grant /Research Support; Pfizer, Allergan, Boston Scientific, Interstitial Cystitis Association
•  Source of funding: Allergan has provided an independent educational research grant to help defray costs in performing this study, as
well as provision of medication needed for the study
References
1.  Rao A, Abbott J. (2009) Using botulinum toxin for pelvic indications in women. Aust N Z J Obstet Gynaecol 49(4):352-357.
2.  Abbott JA, Jarvis SK, Lyons SD, Thomson A, Vancaille TG. (2006) Botulinum toxin type A for chronic pain and pelvic floor
spasm in women: a randomized controlled trial. Obstet Gynecol 108(4):915-923.
3.  Hubbard, D.R. and G.M. Berkoff, MYOFASCIAL TRIGGER POINTS SHOW SPONTANEOUS NEEDLE EMG ACTIVITY. Spine,
1993. 18(13): p. 1803-1807.