Clinical Trial: Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Treatment of Pain Using a Non-implanted Intra-vaginal Electrical Stimulation Device Compared to Sham Device in Chronic Pelvic Pain

Brief Summary: The goal of the study is to evaluate the use of a personal intravaginal, non- implanted electrical stimulation device in the treatment of chronic pelvic pain. The investigators propose a randomized controlled trial comparing the investigated device to a sham device. The primary outcome is pain control using the visual analog scale and brief pain inventory (18). Hypothesis: Subjects will report increased pain relief with the electrical stimulation device compared to those using the sham device alone.

Detailed Summary:

Chronic pelvic pain (CPP) is a complex and devastating diagnosis, encompassing multiple different conditions. Many organ systems may be involved including musculoskeletal, neurologic, genitourinary, psychiatric or gastrointestinal systems. Furthermore, it can be associated with major insomnia, psychosexual trauma, and mood disorders resulting in challenging cases characterized by pain that is refractory to standard treatment modalities. In a study conducted by Mathias et al., one in seven women experience chronic pelvic pain. The economic burden can be substantial, with previous estimates of 2.8 billion dollars per year. (1) Dyspareunia is defined as recurrent or persistent pain associated with sexual intercourse and affects approximately 8-21% of women in the United States (19, 20). Understandably, women with dyspareunia often suffer a decline in sexual functioning. It may lead to decreased arousal, loss of libido, and anorgasmia. However, its impact extends beyond sexual functioning as it can affect a woman's reproductive health and overall sense of well-being. Previous estimates indicate that 88% of sexually active chronic pelvic pain patients report pain during or after intercourse (1).

Treatment of chronic pelvic is challenging due to a poor understanding of pain processing and physiology. Each patient's experience of pain is unique and may be any combination of visceral, neuropathic, or even somatic in etiology. Persistent pain despite aggressive treatment of organic etiologies may imply a psychogenic overlay. A comprehensive and integrative approach is ideal and may include physical therapy, medications, or cognitive behavioral therapy.

Pelvic floor physical therapy is an effective treatment. Pelvic floor rehabilitation addresses the pelvic floor dysfunction and may include manual therapy, transvaginal biofeedback a
Sponsor: The Cleveland Clinic

Current Primary Outcome: Change in pain score from baseline to 12 weeks will be compared using a two-sample t-test. [ Time Frame: Assessments at baseline, 4 weeks, 8 weeks and 12 weeks ]

The visual analog scale will assess pain scores. A multivariable linear regression model may be considered if baseline differences between groups are observed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of Life Questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks ]
    Short Form-36 will be used to evaluate overall quality of life. Changes in SF-36 subscores from baseline to 12 weeks will be compared using Wilcoxon rank sum tests.
  • Sexual Function Index [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    The Female Sexual Function Index will be used to evaluate sexual function. Changes in FSFI subscales from baseline to 12 weeks will be compared using Wilcoxon rank sum tests.
  • Use of pain medications Questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    Use of pain medications will be assessed using a daily pain medication journal. Patients will complete a journal listing the type, amount and dosage of pain medications used on a daily basis. Frequency of medication from baseline to 12 weeks may be compared using a poison regression model. Dose of medication will be compared using a Wilcoxon's rank sum test.


Original Secondary Outcome: Same as current

Information By: The Cleveland Clinic

Dates:
Date Received: March 20, 2015
Date Started: April 2015
Date Completion: July 2017
Last Updated: April 18, 2017
Last Verified: April 2017