Is NCT04133675 recruiting in Royal Oak, MI?

Yes, NCT04133675 is currently recruiting participants at its Royal Oak, MI location. This stress urinary incontinence clinical trial is actively enrolling qualified participants.

How do I join the stress urinary incontinence clinical trial in Royal Oak?

To join this clinical trial in Royal Oak, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Royal Oak clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Stress Urinary Incontinence Clinical Trial in Royal Oak, MI

About This Stress Urinary Incontinence Study in Royal Oak

Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.

Sponsor: Corewell Health East

Who Can Participate

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, inclusive, at screening

Positive Cough or Bladder Stress Test at screening

Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods. 6\. Subject agrees to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonist, or α-adrenergic blockers, throughout the treatment and follow-up periods. For Females Only:

Subject agrees to discontinue use of bladder support devices, including but not limited to vaginal pessary, during the screening, treatment, and follow-up periods.

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)) For Males Only: \- Subject must be ≥ 4 months post radical prostatectomy

Exclusion Criteria

Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening

Subject is morbidly obese (defined as body mass index 40 or greater)

Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure or 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)

Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities

Implanted cardiac pacemaker or metal in the body, including, but not limited to drug pumps, neurostimulators, electronic implants, copper intrauterine devices (IUDs), and/or defibrillators

Subject has a piercing between the waist and knees and is not willing to remove it before each treatment

Active urethral diverticula

Known vesicoureteral reflux

Currently healing from surgical procedures where muscle contraction may disrupt the healing process

Treatment with urethral bulking agents within the 6 months prior to the Screening Visit

Subject is currently receiving treatment for a malignant tumor that would interfere with study participation.

Subject has used the BTL EMSELLA device previously

Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc.

Clinically confirmed urinary tract infection, requiring treatment as determined by the investigator, at the Screening Visit

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

History of surgery with insertion of vaginal mesh for SUI

Vaginal prolapse beyond the introitus

Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within the 6 months prior to the Screening Visit

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Royal Oak?

Yes, this clinical trial (NCT04133675) has an active research site in Royal Oak, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Stress Urinary Incontinence Treatment Options in Royal Oak, MI

If you're searching for stress urinary incontinence treatment options in Royal Oak, MI, this clinical trial (NCT04133675) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Royal Oak research site is actively enrolling participants for this clinical trial. You'll receive care from experienced stress urinary incontinence specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all stress urinary incontinence clinical trials near you to find additional studies recruiting in your area.

Stress Urinary Incontinence Clinical Trial in Royal Oak, MI

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