Overactive Bladder SyndromeEmsellaOABNCT04873037
BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder
A study testing BTL Emsella Chair in people with Overactive Bladder Syndrome and Overactive Bladder, run by Corewell Health East at 1 site in United States.
Trial 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 overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome, Overactive Bladder, Urinary Frequency
- What is being tested?
- BTL Emsella Chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2021to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Women and men ≥ 18 years of age
- Self-reported bladder symptoms present ≥ 3 months
- Self-reported failed conservative care of behavioral modifications and/or oral medications
- 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
- Ambulatory and able to use a toilet independently, without difficulty
Show all 9Show fewer
- Subject agrees not to start any new treatment for OAB (medication or otherwise) during the treatment and follow-up periods.
- 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, IUD, implantable contraceptive, surgical sterilization (bilateral tubal ligation), vasectomized partner(s))
Who cannot join
- Botox® use in bladder or pelvic floor muscles in the past year
- Subject weighs greater than 330 pounds
- 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)
- Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and thighs, at the discretion of the investigator.
- 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.
- Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
Show all 19Show fewer
- Active urethral diverticula
- Known vesicoureteral reflux
- Currently healing from surgical procedures where muscle contraction may disrupt the healing process
- Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. Skin cancers are permitted.
- 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, neurogenic bladder etc.
- 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
- 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)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Danielle Tenney, 248-551-3565, Danielle.Tenney@corewellhealth.org
Jennifer Giordano, BSN, 248-551-3517, Jennifer.Giordano@corewellhealth.org
About this study
Official title: A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Overactive Bladder
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.
Read the detailed description
Overactive bladder (OAB) is a common and often debilitating condition in both men and women. OAB symptoms including urinary frequency, urgency, and/or urge incontinence (UI), have been found to negatively impact quality of life. Due to side effects and the lack of patient compliance to pharmacologic treatments for OAB, non-pharmacologic treatments are in high demand for this condition. Neuromodulation therapies have become increasingly popular for the treatment of overactive bladder in men and women. These neuromodulation therapies work in treating OAB by stimulating the pudendal nerve. The BTL EmsellaTM (Emsella Chair) is a conservative neuromodulation therapy that may have a role for patients who are not surgical candidates or who desire a noninvasive treatment option. The ideal treatment for OAB is still lacking. Many patients are interested in pursuing conservative treatment options. The Emsella chair may have a role for patient who do not desire surgery found with SNM or desire a noninvasive treatment option.
The Emsella chair is approved as a treatment for stress urinary incontinence (SUI). Overactive bladder patients may benefit from treatment. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.
- Being tested
- BTL Emsella Chair, Sham BTL Emsella Chair
- Keywords
- Overactive Bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL Emsella ChairDevice
The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes. The treatment paradigm consists of 3 different phases. The phases consist of an intense stimulation of the pelvic floor muscles (PFM), which consists of stimulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.
Sham BTL Emsella ChairDevice
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 therapeutic level (less than 10%) power.
| Study group | Role | What they receive |
|---|---|---|
| Emsella Chair Active Treatment | Active comparator | Active subjects will be asked to sit on the center of 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 reminder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%. Receives: Device: BTL Emsella Chair |
| Emsella Chair Sham Treatment | Placebo 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 (less than 10% power). Receives: Device: Sham BTL Emsella Chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the efficacy of Emsella Chair versus Sham by evaluating the proportion of subjects reporting "moderately improved" or "markedly improved" responses on the Global Response Assessment (GRA) for overall bladder symptoms.
The GRA evaluates the patients' perceptions of overall improvement in symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, unchanged, slightly improved, moderately improved, markedly improved).
Measured: 4 weeks after completing all treatments; week 8 of the study
Secondary outcomes (7)
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported urinary urgency, frequency, and leakage episodes as reported in a 3-day voiding diary.
Subjects will record all urinary voids, specifying each episode of urination, urinary leakage, including type, urinary urgency before voiding. In each 3-day voiding diary, subjects are to record voiding data for 3 consecutive days on a paper diary. To be considered valid, each 3-day voiding diary must be recorded within 7 days on either side of a planned visit, based on the date of randomization.
Measured: 4 weeks after completing all treatments; week 8 of the study
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported overactive bladder symptoms as measured by the Overactive Bladder Questionnaire-Short form (OAB-q).
The OAB-q short form is a disease-specific questionnaire that assesses symptom bother and health related quality of life (HRQL) in people with OAB. The OAB-q short form consists of a 6-item symptom bother scale and a 13- item HRQL scale. A higher score indicates a greater severity of symptom bother.
Measured: 4 weeks after completing all treatments; week 8 of the study
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Quality of Life questionnaire (I-QOL).
The I-QOL is a self-reported quality of life measure specific to urinary problems that can be used to assess the impact of urinary problems and their treatment. The I-QOL is a 22 item measure that is divided into three domains: 1) 8-item domain assessing the physical impact of urinary incontinence. 2) 9-item domain assessing psychological impact 3) 5-item domain assessing social impact. Scores are calculated for each domain, and a total summary score can be calculated from all 22 items. A higher scores indicates a greater severity of symptoms on quality of life.
Measured: 4 weeks after completing all treatments; week 8 of the study
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported OAB symptoms (urinary incontinence, urinary urgency, urinary frequency) since start of the study as measured by Global Response Assessment (GRA)
The GRA evaluates the patients' perceptions of overall improvement in symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, unchanged, slightly improved, moderately improved, markedly improved). Three separate GRA's will be administered 1. Urinary incontinence 2. Urinary frequency 3. Urinary urgency
Measured: 4 weeks after completing all treatments; week 8 of the study
Compare the efficacy of Emsella chair versus Sham by the change in subject-reported fecal incontinence as measured by the Wexner Cleveland Clinic Incontinence Score (Wexner Scale).
The Wexner Scale is a self-administered questionnaire to assess the frequency and severity of fecal incontinence. The score takes into account the type and frequency of incontinence and the extent to which it alters the patient's life. The score ranges from 0 (perfect continence) to 20 (complete incontinence). A higher score indicates a greater severity of fecal incontinence.
Measured: 4 weeks after completing all treatments; week 8 of the study
The secondary durability objective for this study is to determine whether subjects in the Emsella Chair active treatment group continue to have a higher responder rate, as measured by the GRA for overall bladder health, compared to the Sham group.
The GRA evaluates the patients' perception of improvement in overall bladder symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, unchanged, slightly improved, moderately improved, markedly improved).
Measured: Treatment durability will be assessed 4 weeks after the primary endpoint; week 12 of the study
The secondary safety objective of this study is to determine the safety and tolerability of Emsella Chair active treatment group compared to Sham.
Safety and tolerability of the Emsella chair compared to sham will be assessed in relation to the incidence of adverse events reported.
Measured: 4 weeks after the primary endpoint visit; week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start22 Nov 2021
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who meet all 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, Corewell Health William Beaumont University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873037
- Sponsor's protocol ID
- 2021-120
- Acronym
- EmsellaOAB
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2021
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Overactive Bladder
- ClinicalTrials.gov ID
- NCT04873037
- Acronym / sponsor ID
- EmsellaOAB / 2021-120
- Keywords
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overactive bladder (OAB) is a common and often debilitating condition in both men and women. OAB symptoms including urinary frequency, urgency, and/or urge incontinence (UI), have been found to negatively impact quality of life. Due to side effects and the lack of patient compliance to pharmacologic treatments for OAB, non-pharmacologic treatments are in high demand for this condition. Neuromodulation therapies have become increasingly popular for the treatment of overactive bladder in men and women. These neuromodulation therapies work in treating OAB by stimulating the pudendal nerve. The BTL EmsellaTM (Emsella Chair) is a conservative neuromodulation therapy that may have a role for patients who are not surgical candidates or who desire a noninvasive treatment option. The ideal treatment for OAB is still lacking. Many patients are interested in pursuing conservative treatment options. The Emsella chair may have a role for patient who do not desire surgery found with SNM or desire a noninvasive treatment option.
The Emsella chair is approved as a treatment for stress urinary incontinence (SUI). Overactive bladder patients may benefit from treatment. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who meet all 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.
| Arm | Type | Receives |
|---|---|---|
| Emsella Chair Active Treatment | Active comparator | Device: BTL Emsella ChairActive subjects will be asked to sit on the center of 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 reminder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%. |
| Emsella Chair Sham Treatment | Placebo comparator | Device: Sham BTL Emsella ChairSham 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 (less than 10% power). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Women and men ≥ 18 years of age
- Self-reported bladder symptoms present ≥ 3 months
- Self-reported failed conservative care of behavioral modifications and/or oral medications
- 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
Key exclusion criteria (19 listed)
- Botox® use in bladder or pelvic floor muscles in the past year
- Subject weighs greater than 330 pounds
- 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)
- Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and thighs, at the discretion of the investigator.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTL Emsella ChairThe Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes. The treatment paradigm consists of 3 different phases. The phases consist of an intense stimulation of the pelvic floor muscles (PFM), which consists of stimulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation. | Device | Emsella Chair Active Treatment |
| Sham BTL Emsella ChairThe 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 therapeutic level (less than 10%) power. | Device | Emsella Chair Sham Treatment |
Primary outcome
Compare the efficacy of Emsella Chair versus Sham by evaluating the proportion of subjects reporting "moderately improved" or "markedly improved" responses on the Global Response Assessment (GRA) for overall bladder symptoms.
Time frame: 4 weeks after completing all treatments; week 8 of the study
The GRA evaluates the patients' perceptions of overall improvement in symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, unchanged, slightly improved, moderately improved, markedly improved).
7 secondary outcomes
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported urinary urgency, frequency, and leakage episodes as reported in a 3-day voiding diary.
Time frame: 4 weeks after completing all treatments; week 8 of the study
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported overactive bladder symptoms as measured by the Overactive Bladder Questionnaire-Short form (OAB-q).
Time frame: 4 weeks after completing all treatments; week 8 of the study
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Quality of Life questionnaire (I-QOL).
Time frame: 4 weeks after completing all treatments; week 8 of the study
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported OAB symptoms (urinary incontinence, urinary urgency, urinary frequency) since start of the study as measured by Global Response Assessment (GRA)
Time frame: 4 weeks after completing all treatments; week 8 of the study
Compare the efficacy of Emsella chair versus Sham by the change in subject-reported fecal incontinence as measured by the Wexner Cleveland Clinic Incontinence Score (Wexner Scale).
Time frame: 4 weeks after completing all treatments; week 8 of the study
The secondary durability objective for this study is to determine whether subjects in the Emsella Chair active treatment group continue to have a higher responder rate, as measured by the GRA for overall bladder health, compared to the Sham group.
Time frame: Treatment durability will be assessed 4 weeks after the primary endpoint; week 12 of the study
The secondary safety objective of this study is to determine the safety and tolerability of Emsella Chair active treatment group compared to Sham.
Time frame: 4 weeks after the primary endpoint visit; week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth Peters, MD principal investigator
Corewell Health William Beaumont University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL Emsella Chair in people with Overactive Bladder Syndrome and Overactive Bladder, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Tenney (248-551-3565, Danielle.Tenney@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the efficacy of Emsella Chair versus Sham by evaluating the proportion of subjects reporting "moderately improved" or "markedly improved" responses on the Global Response Assessment (GRA) for overall bladder symptoms. (time frame: 4 weeks after completing all treatments; week 8 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.