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

NCT02397785 | Completed Results DMC

• 1 other identifier: 15-150
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain

Keywords

chronic pelvic pain; electrical stimulation; pelvic floor rehabilitation; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 12

  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).

  Baseline and Week 12

Secondary Outcomes (19)

• Change From Baseline in Quality of Life on Short Form 36 (SF-36) Physical Functioning Scale

  Baseline and Week 12

• Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Physical Health Scale

  Baseline and Week 12

• Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Emotional Problems Scale

  Baseline and Week 12

• Change From Baseline in Quality of Life on Short Form 36 (SF-36) Energy/Fatigue Scale

  Baseline and Week 12

• Change From Baseline in Quality of Life on Short Form 36 (SF-36) Emotional Wellbeing Scale

  Baseline and Week 12

Study Arms (2)

ApexM Device

EXPERIMENTAL

InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence (10). These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicon and provide electrical stimulation to the pelvic floor. One of the devices, ApexM™ provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. The investigators propose the use of low power electrical stimulation for the treatment of pain in patients diagnosed with CPP. The electrical stimulation is delivered using ApexM™, adjusting the power to a sensory threshold to prevent muscle contraction.

Device: ApexM

Sham Device

SHAM COMPARATOR

Subjects in the control arm will use a sham ApexM device. The original ApexM device will be modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry will be disconnected so that electrical stimulation is disabled.

Device: Sham Device

Interventions

ApexM DEVICE

Subjects will apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity is set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. At the target amplitude, patients will feel a non-painful fluttering or tapping sensation, Subjects will perform this for 6 sessions per week at 12 minutes per session for an additional 12 weeks. At each follow-up visit, investigators will re-evaluate the stimulation level and adjust to avoid muscle contraction.

Also known as: pelvic electrical stimulation device

ApexM Device

Sham Device DEVICE

Identical to ApexM but will not deliver any electrical stimulation

Sham Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Erica Magelky, Principal Investigator
• Organization: Cleveland Clinic Foundation

magelke@ccf.org

713-628-5357

Study Officials

• Mary J Uy-Kroh, MD

  The Cleveland Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 26, 2019
• Results First Posted: March 12, 2018

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)