Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain

NCT04248491 | Terminated Results FDA Device

• 1 other identifier: 2019-348
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Pain

Keywords

Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS)

  Mean change in Pain VAS from baseline to end of treatment will be compared between the Emsella Chair group and the sham group. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. Value at week 8 minus the value at baseline was used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain.

  Baseline and week 8

Secondary Outcomes (14)

• The Change in Subject-reported Impression of CPP Severity as Measured by the Patient Global Impression of Severity Scale (PGI-S).

  Baseline and week 12

• The Number of Participants Reporting Significant Symptom Improvement as Measured by the Patient Global Impression of Improvement Scale (PGI-I)

  at 12 weeks

• The Change in Subject-reported Impression of CPP Severity as Measured by Subject-reported Pelvic Floor Tenderness to Palpation During 4 Quadrant Pelvic Examination as Measured by VAS.

  Baseline and week 12

• The Change in Subject-reported Impression of CPP Severity in Females.

  Baseline and Week 12

• The Change in Subject-reported Impression of CPP Severity in Males.

  Baseline and week 12

Study Arms (2)

Emsella Chair Active Treatment

ACTIVE COMPARATOR

Subjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will be decreased slightly and stay unchanged for the remainder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Device: BTL Emsella chair

Emsella Sham Treatment

SHAM COMPARATOR

Sham treatment subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level (\<10% power).

Device: BTL Emsella chair

Interventions

BTL Emsella chair DEVICE

Subjects will sit on the device. The Research Nurse Coordinator (RNC) will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Emsella Chair Active Treatment; Emsella Sham Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 adverse events (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, Intrauterine device (IUD), implantable contraceptive, surgical sterilization (bilateral tubal ligation), vasectomized partner(s))

You may not qualify if:

• 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 urinary tract infection (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 is currently receiving treatment for a malignant tumor that would interfere with study participation.
• 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
• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was terminated early due to lack of efficacy at an interim analysis point.

Results Point of Contact

• Title: Director Urology Research
• Organization: Beaumont Health

bernadette.zwaans@Corewellhealth.org

2485511488

Study Officials

• Kenneth Peters, MD

  Beaumont Hospital-Royal Oak

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The sham Emsella treatment will provide sensation without active HIFEM technology. The sham treatment amplitude setting will be limited to below the therapeutic level.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chair of the Department of Urology

Model Details: Patients who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive Emsella chair or sham treatments. The subject and biostatistician will be blinded to the group allocation throughout the study. The initial analysis of data, performed by the biostatistician will not include group assignment.

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: July 13, 2020
• Primary Completion: January 18, 2023
• Study Completion: July 13, 2023
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)