Does Adjunctive Treatment With Vaginal Nifedipine Result in Symptomatic Improvement in Patients With Levator Myalgia and Pelvic Floor Pain Who Are Undergoing Pelvic Floor Physical Therapy?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Improvement in Quality of Life
研究概览
简要总结
The objective of this study is to perform a randomized controlled trial among female patients with a diagnosis of pelvic floor hypertonus (extreme muscle tension) with associated pain, dysfunctional voiding, dyspareunia, and/ or obstructed defecation.
详细描述
Given the paucity of information and the magnitude of debilitation that can be associated with chronic pain syndromes, the potential to ameliorate pain and successfully treat these symptoms is an area that merits further exploration. In this study, we hypothesize that the addition of vaginal nifedipine to a physical therapy protocol will result in greater treatment success than treatment with physical therapy alone.
The objective is to perform a randomized controlled trial among female participants with a diagnosis of pelvic floor hypertonus with associated pain, dysfunctional voiding, dyspareunia, and/or obstructed defecation. Group 1 will serve as the control and will undergo pelvic floor physical therapy and placebo (lanolin and mineral oil base). Group 2 will also undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine.
Specific aims include:
- Comparison of subjective outcome measures, specifically quality of life metrics scales: Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and validated 11-point pain scale.
- Comparison of objective outcome measures, specifically a validated digital assessment of pelvic floor strength: the Oxford scale.
Group 1 will serve as the control and will undergo pelvic floor physical therapy and placebo (lanolin base). Group 2 will also undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine. We will collect data on these patients to determine if the treatment of vaginal nifedipine with physical therapy provides a more successful treatment for this pelvic floor dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subject has levator myalgia upon appropriate pelvic exam that reproduces HPI pain
- •Subject has symptoms such as voiding dysfunction, dyspareunia, vaginismus, or obstructed defecation
- •Subject is willing and able to give written consent for the study
- •Subject is willing to undergo treatment with pelvic physical therapy & vaginal nifedipine
- •Subject is able to speak, read, and write in English
- •Subject is at least 18 years of age
排除标准
- •Subject has previously diagnosed interstitial cystitis
- •Subject has an active case of symptomatic HSV, syphilis, or shingles
- •Subject has a history of uncontrolled hypertension
- •Subject is already taking a calcium channel blocker
- •Subject has a history of MI, CHF, or arrhythmia
- •Subject has a history of neurologic disease
- •Subject has a history of congenital or progressive musculoskeletal disease
- •Subject has a history of bladder or pelvic cancer and/or pelvic radiation
- •Subject is planning to be or currently pregnant
- •Subject has known allergy or adverse reaction to nifedipine
- •Subject has known allergy or adverse reaction to lanolin, mineral oil, petrolatum
- •Subject is undergoing pharmacologic treatment specific to pelvic pain
- •Subject is taking oral beta adrenergic antagonist medication
- •Subject has an active pelvic or vaginal infection
- •Subjects with hypotension on screening physical examination (i.e. confirmed SBP<90 mmHg or DBP<60 mmHg).
研究组 & 干预措施
Ointment Base
Patients in this arm will serve as the control and will undergo pelvic floor physical therapy and receive placebo (lanolin and mineral oil base).
干预措施: Placebo Ointment Base (Drug)
Nifedipine Ointment
Patients in this arm will undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine.
干预措施: Nifedipine (Drug)
结局指标
主要结局
Improvement in Quality of Life
时间窗: To be assessed 1 month post-treatment.
The primary outcome will measure quality of life metrics, as reported by the patient herself. We will use the following validated instruments: Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and validated 11-point pain scale. The aim is to measure whether the patient experienced improvement in her symptoms when vaginal nifedipine was administered (in addition to physical therapy).
次要结局
- Improvement in Hypertonic Pelvic Floor Muscles(To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months)
研究者
Daniel Biller
Assistant Professor
Vanderbilt University