RECRUITING

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

Conditions

Overactive Bladder Syndrome Overactive Bladder Urinary Frequency Urinary Urgency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

Official Title

A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Overactive Bladder

Quick Facts

Study Start:2021-11-22

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04873037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Women and men ≥ 18 years of age 3. Self-reported bladder symptoms present ≥ 3 months 4. Self-reported failed conservative care of behavioral modifications and/or oral medications 5. On a stable dose of antimuscarinics/beta-3 agonists for ≥ 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for ≥ 2 weeks 6. Ambulatory and able to use a toilet independently, without difficulty 7. Subject agrees not to start any new treatment for OAB (medication or otherwise) during the treatment and follow-up periods. 8. 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))	1. Botox® use in bladder or pelvic floor muscles in the past year 2. Subject weighs greater than 330 pounds 3. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis) 4. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and thighs, at the discretion of the investigator. 5. 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. 6. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment 7. Active urethral diverticula 8. Known vesicoureteral reflux 9. Currently healing from surgical procedures where muscle contraction may disrupt the healing process 10. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. Skin cancers are permitted. 11. Subject has used the BTL EMSELLA device previously 12. Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, neurogenic bladder etc. 13. Current urinary tract infection. If a subject has a confirmed symptomatic UTI at screening, per investigator's clinical judgment, they will be deferred from screening until treatment is completed, and may resume once symptoms have resolved 14. Current use of neuromodulation therapy, including interstim and PTNS, for bladder symptoms within 3 months of screening visit (if past sacral/pudendal implant, must be explanted) 15. 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 16. 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 17. 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.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Women and men ≥ 18 years of age
3. Self-reported bladder symptoms present ≥ 3 months
4. Self-reported failed conservative care of behavioral modifications and/or oral medications
5. On a stable dose of antimuscarinics/beta-3 agonists for ≥ 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for ≥ 2 weeks
6. Ambulatory and able to use a toilet independently, without difficulty
7. Subject agrees not to start any new treatment for OAB (medication or otherwise) during the treatment and follow-up periods.
8. 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))

1. Botox® use in bladder or pelvic floor muscles in the past year
2. Subject weighs greater than 330 pounds
3. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
4. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and thighs, at the discretion of the investigator.
5. 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.
6. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
7. Active urethral diverticula
8. Known vesicoureteral reflux
9. Currently healing from surgical procedures where muscle contraction may disrupt the healing process
10. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. Skin cancers are permitted.
11. Subject has used the BTL EMSELLA device previously
12. Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, neurogenic bladder etc.
13. Current urinary tract infection. If a subject has a confirmed symptomatic UTI at screening, per investigator's clinical judgment, they will be deferred from screening until treatment is completed, and may resume once symptoms have resolved
14. Current use of neuromodulation therapy, including interstim and PTNS, for bladder symptoms within 3 months of screening visit (if past sacral/pudendal implant, must be explanted)
15. 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
16. 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
17. 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.

Contacts and Locations

Study Contact

Danielle Tenney

CONTACT

248-551-3565

danielle.tenney@corewellhealth.org

Jennifer Giordano, BSN

CONTACT

248-551-3517

Jennifer.Giordano@beaumont.org

Principal Investigator

Kenneth Peters, MD

PRINCIPAL_INVESTIGATOR

Beaumont Hospital-Royal Oak

Study Locations (Sites)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073

United States

Collaborators and Investigators

Sponsor: William Beaumont Hospitals

Kenneth Peters, MD, PRINCIPAL_INVESTIGATOR, Beaumont Hospital-Royal Oak

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-22

Study Completion Date2027-12

Study Record Updates

Study Start Date2021-11-22

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Overactive Bladder

Additional Relevant MeSH Terms

Overactive Bladder Syndrome
Overactive Bladder
Urinary Frequency
Urinary Urgency