A Prospective Cohort Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score
研究概览
简要总结
This study assesses whether the addition of chemodenervation to an established regimen of pelvic floor physical therapy for painful high tone pelvic floor dysfunction improves patients' objective and subjective outcomes. Study subjects will select one of three treatment approaches: injection of 50 units Botulinum toxin A with local sedation as an office procedure, injection of 100u BoNTA-cosmetic in either the office or while anesthetized, or injection of 150 units Botulinum toxin A while anesthetized.
详细描述
High-tone pelvic floor dysfunction is often a painful condition that can be associated with a number of female pelvic syndromes including childhood elimination disorders, idiopathic urinary retention, vaginismus, dyspareunia, pelvic pain, constipation, sport injuries, postoperative and bladder pain syndrome/interstitial cystitis. Following appropriate patient education about pelvic floor function, mainstays of therapy for high-tone pelvic floor dysfunction pelvic pain include pharmacotherapeutic agents and pelvic floor physical therapy. The investigators hypothesize that chemodenervation with Botulinum toxin A will offer a safe, efficacious intervention for women with high tone pelvic floor dysfunction that cannot be adequately treated with pelvic floor physical therapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •>6 month history of pelvic pain or dyspareunia with high tone pelvic floor dysfunction on exam (pain with palpation of superficial transverse perineii, bulbocavernosus insertion to perineal/central tendon and/or levator ani complex/iliococcygeus)
- •Women with male sexual partners
- •History of undergoing pelvic floor physical therapy with internal manipulation including trigger point release as directed, with inability to meet goals of therapy despite appropriate pelvic floor physical therapy approach
- •Able to read, write, and comprehend English sufficiently to offer informed consent
排除标准
- •Presence of intact hymen, preventing internal manipulation during pelvic floor physical therapy
- •Pregnancy at the time of injection
- •Breast feeding at the time of injection
- •History of Myasthenia Gravis, Amyotrophic Lateral Sclerosis, Lambert-Eaton syndrome, allergy to Botulinum toxin A, or other contraindication to Botulinum toxin A injection
- •History of documented skin disorder of the vulva other than vaginal atrophy or lichen planus
- •Prior pelvic radiation
- •Stage II-IV pelvic organ prolapse
- •Has had a pelvic floor Botulinum toxin A injection within the last 12 weeks
- •Unable to provide informed consent
研究组 & 干预措施
Botulinum toxin A 50u
Botulinum toxin A 50 unit injection
干预措施: Botulinum toxin A 50u (Drug)
Botulinum toxin A 100u
Botulinum toxin A 100 unit injection
干预措施: Botulinum toxin A 100u (Drug)
Botulinum toxin A 150u
Botulinum toxin A 150 unit injection
干预措施: Botulinum toxin A 150u (Drug)
结局指标
主要结局
Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score
时间窗: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
This is a single question, "How severe is your pelvic pain at this time?"
次要结局
- Visual Analog Pain Scale (Dyspareunia)(Baseline, Week 2, Month 3, Month 6, Month 9, Month 12)
- Patient Global Impression of Severity(Baseline, Week 2, Month 3, Month 6, Month 9, Month 12)
- Pelvic Floor Distress Inventory Questionnaire(Baseline, Week 2, Month 3, Month 6, Month 9, Month 12)
- Female Sexual Function Index(Baseline, Week 2, Month 3, Month 6, Month 9, Month 12)
- Patient Global Impression of Improvement(Week 2, Month 3, Month 6, Month 9, Month 12)