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NCT02397785 · ClinicalTrials.gov registry record · NA
Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
NCT02397785: Completed NA study, sponsored by The Cleveland Clinic.
NCT02397785 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 58 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02397785, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
Study 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.
Primary Outcome
The Visual Analog Scale assesses self-reported pain scores. Patients were asked to record their average pain over the past 4 weeks by placing an "X" on a 10-cm line, with 0 representing no pain and 100 representing the worst pain imaginable. Pain scores were determined by research personnel by measuring the distance (in mm) from 0 to the X. Change = (Week 12 Score - Baseline Score).
Interventions
- DEVICE Sham Device
- DEVICE ApexM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2015-04 |
| Est. Completion | 2017-06 |
| Phase | NA |
What the finished NCT02397785 record still lists
NCT02397785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Device is the first listed.
NCT02397785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02397785 about?
NCT02397785 is a clinical study titled "Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain". 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 contr...
What is the current status of trial NCT02397785?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2015-04. Estimated completion is 2017-06.
What interventions are being tested in trial NCT02397785?
The interventions under investigation include: Sham Device (DEVICE), ApexM (DEVICE).
Who is sponsoring clinical trial NCT02397785?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02397785's enrollment target sits among peer trials
58 1256th of 2000 higher than 740 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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