Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain (EmsellaPain)

  • STATUS
    Recruiting
  • End date
    Jan 7, 2023
  • participants needed
    60
  • sponsor
    William Beaumont Hospitals
Updated on 25 February 2022
chronic pelvic pain

Summary

The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of chronic pelvic pain. Currently there are no other studies utilizing the Emsella Chair for the treatment of chronic pelvic pain. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

Description

Chronic pelvic pain (CPP) is a common and often debilitating in both men and women. It occurs below the umbilicus and is severe enough to cause functional impairment or require treatment. The health care burden of CPP is substantial. First line treatments involve a multidisciplinary approach and include general relaxation and stress management, patient education, self-care and behavioral modification, and pain management. Second-line agents include physical therapy (avoiding kegel exercises), and oral and intravesical agents. More invasive options including neuromodulation.

The Emsella chair is currently approved as a treatment for stress urinary incontinence. Chronic pelvic pain patients may benefit from treatment. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related discorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.

Details
Condition Pelvic Pain
Treatment BTL Emsella chair
Clinical Study IdentifierNCT04248491
SponsorWilliam Beaumont Hospitals
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information
Females and males, 18 to 80 years of age, at screening
Self-reported CPP defined as pelvic pain that is non-cyclical and of at least 6 months duration and refractory to other treatments
Subject agrees not to start any new treatment for CPP (medication or otherwise) during the treatment and follow-up periods
Subject agrees to maintain a stable dose all current medications throughout the treatment and follow-up period
For Females Only
\. If of child-bearing age and female, agree to practice approved birth-
control methods (oral contraceptives, condom barrier, injection, diaphragm or
cervical cap, vaginal contraceptive ring, IUD, implantable contraceptive
surgical sterilization (bilateral tubal ligation), vasectomized partner(s))

Exclusion Criteria

Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
Pelvic floor trigger point injections, pudendal nerve block, or bladder hydrodistention within 30 days prior to screening
Subject weighs more than 330 pounds
Current UTI. If a subject has a confirmed symptomatic UTI at screening, per the investigator's clinical judgment, they will be deferred from screening until treatment is completed, and may resume once symptoms have resolved
Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
Subject has a malignant tumor, in any location on the body
Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
History of Hunner's lesion in the medical record
Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, copper intrauterine devices, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study
Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
Subject has used the BTL EMSELLA device previously
Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit
Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
For Females Only
\. Pregnant, or planning to become pregnant, at screening or anytime
throughout the study period
Note: For the sake of preserving scientific integrity, one or more of the
eligibility criteria have been left off the list posted while the trial is
ongoing. A full list of eligibility criteria will be posted upon completion of
the trial
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