Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT05370651
Eligibility Criteria:
Inclusion 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 adverse events and other clinically important information.
2. Men ≥ 18 years of age.
3. Sexually active within the past 12 weeks and plan to be sexually active during the next 12 weeks.
5\. Self-reported ejaculatory dysfunction symptoms present \>3 months 6. Self-reported failed conservative care of behavioral modifications and/or oral medications.
7\. Subject agrees not to start any new treatment for erectile dysfunction or ejaculatory dysfunction during the treatment and follow-up periods.
Exclusion Criteria:
1. Botox® use in bladder or pelvic floor muscles in the past year
2. Subject weighs greater than 330 pounds, due to weight limits of the Emsella Chair.
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, thigh, or buttocks.
5. Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, 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. Previous or current penile prosthesis.
7. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
8. Active urethral diverticula
9. Known history of urethral stricture disease
10. Currently healing from surgical procedures where muscle contraction may disrupt the healing process
11. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation.
12. Subject has used the BTL EMSELLA device previously
13. Subject has sexual dysfunction of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, neurogenic bladder etc.
14. Current use of neuromodulation therapy, including Interstim and percutaneous tibial nerve stimulation (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
* 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05370651
Study Brief:
Protocol Section:
NCT05370651