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Published on: November 9, 2016
Modified Delphi Consensus Guidelines for Pelvic Floor Botulinum Toxin Injection
Demetra H Hufnagel1, Michele Torosis1, A Lenore Ackerman1,2
1Departments of Obstetrics and Gynecology.
Importance:
Myofascial pelvic pain (MPP) is an under-treated etiology of pelvic pain, presenting with pelvic floor tender points and/or increased tension. While limited data support off-label use of pelvic floor botulinum toxin (BTA) injections for refractory MPP, clinical guidance on its utilization is lacking.
Objective:
We sought to develop consensus-based guidelines for pelvic floor BTA injection.
Study Design:
We identified 46 potential experts in the use of pelvic floor BTA injection based on research, clinical volume, and publication of patient-facing materials, 18 of whom agreed to participate. Consensus, defined as at least 70% agreement or disagreement, was determined through 3 rounds of electronic surveys using a modified Delphi method between September 2023 and July 2024.
Results:
A total of 15 practitioners completed the first survey, with most based in the United States (93%), working in academic settings, with Obstetrics and Gynecology training (85%). Expert consensus supports that BTA injection is a third-line therapy for high-tone pelvic floor dysfunction and myofascial pelvic pain. Its use may also be considered for involuntary vaginismus, vestibulodynia, and anismus/dyssynergic defecation. Preprocedural examination is sufficient to localize sites and should palpate the puborectalis, pubococcygeus, iliococcygeus, and obturator internus. Injections of 100-200 units total should focus on areas of increased tenderness/hypertonicity; however, for global symptoms or inability to tolerate examination, templated injections may be used. Experts did not support performing local anesthetic injections to predict responses. Injection is performed transvaginally with each muscle group receiving 20-50 units BTA in divided 1-2 mL injections. Injections are performed bilaterally. Patients should be followed by quantitative pain assessments with repeat injections as needed.
Conclusions:
Using a modified Delphi method, we describe expert consensus-based guidelines for pelvic floor BTA injection to provide practical guidance for its use.
Insights
Botulinum toxin (BTA) injections are recommended as a third-line therapy for myofascial pelvic pain and high-tone pelvic floor dysfunction. These expert-guided protocols offer practical insights for BTA utilization in treating pelvic pain conditions.
Area of Science:
- Pelvic pain management
- Neuromodulation therapies
- Musculoskeletal disorders
Background:
- Myofascial pelvic pain (MPP) is a common cause of pelvic pain, often characterized by pelvic floor muscle hypertonicity.
- Current treatment options for refractory MPP are limited, with a lack of established clinical guidelines for off-label therapies like botulinum toxin (BTA) injections.
Purpose of the Study:
- To establish consensus-based guidelines for the utilization of pelvic floor botulinum toxin (BTA) injections.
- To provide practical guidance for clinicians managing patients with refractory myofascial pelvic pain and related conditions.
Main Methods:
- A modified Delphi method was employed, involving three rounds of electronic surveys.
- Expert consensus was achieved among 18 specialists in pelvic floor BTA injection, identified through research, clinical volume, and patient-facing materials.
- Surveys were conducted between September 2023 and July 2024 to determine agreement on BTA injection protocols.
Main Results:
- Botulinum toxin (BTA) injection is supported as a third-line therapy for high-tone pelvic floor dysfunction and myofascial pelvic pain.
- Consideration for BTA use in vaginismus, vestibulodynia, and anismus/dyssynergic defecation was agreed upon.
- Guidelines detail preprocedural examination, injection sites (puborectalis, pubococcygeus, iliococcygeus, obturator internus), total dosage (100-200 units), and bilateral transvaginal administration (20-50 units per muscle group).
Conclusions:
- Consensus-based guidelines for pelvic floor BTA injection were developed using a modified Delphi method.
- These guidelines offer practical recommendations for the effective use of BTA in managing myofascial pelvic pain and related conditions.
- The study provides much-needed clinical guidance for this under-treated etiology of pelvic pain.
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