N/A
N=58
Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain
Pelvic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02397785 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 12 — -8.5; -7.4 units on a scale — p=0.8979
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ApexM (Device); Sham Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 12 |
-8.5; -7.4 | 0.8979 |
| SECONDARY Change From Baseline in Quality of Life on Short Form 36 (SF-36) Physical Functioning Scale |
1.4; 1.6 | 0.9338 |
| SECONDARY Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Physical Health Scale |
1.13; 21 | 0.1568 |
| SECONDARY Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Emotional Problems Scale |
-7.6; 2.7 | 0.3817 |
| SECONDARY Change From Baseline in Quality of Life on Short Form 36 (SF-36) Energy/Fatigue Scale |
1.8; 7.2 | 0.2860 |
| SECONDARY Change From Baseline in Quality of Life on Short Form 36 (SF-36) Emotional Wellbeing Scale |
-2.9; 0.8 | 0.2884 |
| SECONDARY Change From Baseline in Quality of Life on Short Form 36 (SF-36) Social Function Scale |
-3.4; 5.5 | 0.0855 |
| SECONDARY Change From Baseline in Pain on Short Form 36 (SF-36) Pain Scale |
5.2; 18.1 | 0.0287 sig |
| SECONDARY Change From Baseline in Quality of Life on Short Form 36 (SF-36) General Health Scale |
-3.1; 0 | 0.2887 |
| SECONDARY Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Severity Scale |
-0.4; -0.4 | 0.9954 |
| SECONDARY Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Interference Scale |
-0.06; -1.1 | 0.0574 |
| SECONDARY Change From Baseline in Quality of Life on Female Sexual Function Index (FSFI) Scale |
2.7; 1.9 | 0.7827 |
| SECONDARY Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Pelvic Organ Prolapse Distress Inventory (POPDI) Sub-Scale |
-4.7; -9.3 | 0.2114 |
| SECONDARY Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Colorectal Anal Distress Inventory (CRADI) Sub-Scale |
-4.1; -6.5 | 0.4986 |
| SECONDARY Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) Sub-Scale |
-6.3; -10 | 0.4610 |
| SECONDARY Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Total Scale |
-15.2; -25.8 | 0.2556 |
| SECONDARY Change From Baseline in Weekly Ibuprofen Use |
200; -400 | 0.0723 |
| SECONDARY Change From Baseline in Weekly Naprosyn Use |
-35.3; -62.9 | 0.7456 |
| SECONDARY Change From Baseline in Weekly Acetaminophen Use |
125; -333 | 0.1380 |
| SECONDARY Change From Baseline in Weekly Opioid Use |
-0.25; 0 | 0.3155 |
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.
Eligibility Criteria
Inclusion Criteria
- Women >/= 18 years old who are sexually active or desire to be sexually active, no active infection, diagnosed with non-cyclic chronic pelvic pain, duration of symptoms greater than 6 months, neurologically intact, able to accommodate and tolerate the device, not pregnant and not attempting to achieve pregnancy.
Exclusion Criteria
- Pregnancy, currently active in pelvic floor physical therapy, active malignancy, patients unable to contract their pelvic floor secondary to causes such as myelopathy, spinal cord trauma, patients with diabetes, vestibulodynia, vulvodynia, a pacemaker, defibrillator or other implanted neuro-modulatory devices, patients with a hypotonic pelvic floor, or those currently on treatment for pain with topical lidocaine, gabapentin or other medications or injections outside of standard analgesics, and severe psychiatric disorders
Data sourced from ClinicalTrials.gov (NCT02397785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.