RECRUITING

Emsella Chair vs Sham for Male Sexual Dysfunction

Conditions

Male Sexual Dysfunction Ejaculatory Dysfunction

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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

We will be performing this study in 2 phases: Phase 1 will be an open label pilot study of 10 male participants. All participants in the pilot study will receive active treatment. If data from the pilot study is suggestive of symptom improvement, we will continue on to phase 2, which is a sham controlled, randomized blinded study. Participants in phase 2 will be randomized to receive either active treatment or sham. Potentially a total of 117 participants for both phases will be enrolled. The purpose of this study is to compare the Emsella Chair to sham and to determine whether electromagnetic technology is effective in the treatment of sexual dysfunction, specifically erectile dysfunction (EjD) in men.

Official Title

A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Male Sexual Dysfunction

Quick Facts

Study Start:2022-12-14

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05370651

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:MALE

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 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.	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.

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 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.

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.

Contacts and Locations

Study Contact

Jo Medado-Ramirez, BSN

CONTACT

248-551-7360

Josephine.Medado-Ramirez@corewellhealth.org

Jennifer Giordano, BSN

CONTACT

248-551-3517

Jennifer.Giordano@corewellhealth.org

Principal Investigator

Kenneth Peters, MD

PRINCIPAL_INVESTIGATOR

Corewell Health William Beaumont University Hospital

Study Locations (Sites)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

Collaborators and Investigators

Sponsor: William Beaumont Hospitals

Kenneth Peters, MD, PRINCIPAL_INVESTIGATOR, Corewell Health William Beaumont University Hospital

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 Date2022-12-14

Study Completion Date2027-01

Study Record Updates

Study Start Date2022-12-14

Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

Male Sexual Dysfunction

Additional Relevant MeSH Terms

Male Sexual Dysfunction
Ejaculatory Dysfunction