Benign Prostatic HyperplasiaNCT07580404
Emsella for Reducing tSUI After HOLEP
A study testing Emsella chair in people with Benign Prostatic Hyperplasia and Enlarged Prostate With Lower Urinary Tract Symptoms, run by Northwestern University at 1 site in United States.
Trial summary
This study aims to investigate the effectiveness of the Emsella chair treatments at different timepoints. Before and after the holmium laser enucleation of the prostate (HoLEP). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms, Enlarged Prostate (BPH)
- What is being tested?
- Emsella chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2026to Jul 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 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prostate sizing 80-150g
- Ability to independently transfer and tolerate all 30min Emsella treatments (e.g. not wheelchair bound, no mobility issues)
- Baseline M-ISI scores <4
- Same-day catheter removal and discharge
- Able to read, understand, and complete surveys and questionnaires
Who cannot join
- Catheter dependence
- Previous BPH procedure
- Previous pelvic surgeries
- Pre-existing pelvic floor dysfunction
- Neurogenic bladder
- Overactive bladder - e.g. prescribed and taking any oxybutynin or mirabegron
- Preoperative pad-use for incontinence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Utility of Emsella for Reducing Transient Stress Urinary Incontinence (tSUI) Following Holmium Laser Enucleation of the Prostate (HoLEP)
This study aims to investigate the effectiveness of the Emsella chair treatments at different timepoints. Before and after the holmium laser enucleation of the prostate (HoLEP).
Read the detailed description
Emsella is a non-invasive treatment used to activate and strengthen the pelvic floor. One Emsella treatment is reported to be the equivalent of performing 11,000 Kegel exercises. This study aims to examine the effectiveness of Emsella chair treatments in reducing the likelihood of tSUI following HoLEP by comparing the outcomes of patients who completed treatments at different points of time around their HoLEP procedure.
- Conditions
- Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms, Enlarged Prostate (BPH)
- Being tested
- Emsella chair
- Keywords
- HoLEP, Emsella
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emsella chairDevice
Emsella is a non-invasive treatment used to activate and strengthen the pelvic floor. One Emsella treatment is reported to be the equivalent of performing 11,000 Kegel exercises.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care (Kegel Exercises) | No intervention | Patients are reminded to perform pelvic floor exercises known as Kegel exercises for 3 weeks leading up to their scheduled HoLEP procedure, and continue Kegel exercises for 3 weeks following the HoLEP procedure. |
| Pre-HoLEP Emsella | Active comparator | Participants will complete 2 30-minute Emsella treatment sessions for 3 weeks (for a total of 6 30-minute Emsella chair treatment sessions) leading up to their scheduled HoLEP procedure.
They will undergo the HoLEP 1 week after the final Emsella treatment session. Receives: Device: Emsella chair |
| Post-HoLEP Emsella | Active comparator | Participants will complete 2 30-minute Emsella treatment sessions for 3 weeks (for a total of 6 30-minute Emsella chair treatment sessions) following their scheduled HoLEP procedure.
They will begin their first Emsella treatment session 1 week after HoLEP. Receives: Device: Emsella chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Michigan Incontinence Score (M-ISI)
The Michigan Incontinence Score (M-ISI) is a 10-item questionnaire designed to assess urinary incontinence type, severity, and bother, with a focus on stress and urge incontinence. The tool is commonly used to screen for clinically relevant symptoms, with a total score of greater than or equal to 7 suggesting a need for intervention.
Measured: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP
Difference in International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (IPSS) is a 7-question tool (0-35 points) used in urology to assess Benign Prostatic Hyperplasia (BPH) severity, plus one quality-of-life question. It measures symptoms like frequency, urgency, weak stream, and nocturia, with scores of 0-7 (Mild), 8-19 (Moderate), and 20-35 (Severe).
Measured: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP
Secondary outcomes (1)
Difference in safety/adverse effects
Adverse effects reported by patient or detected from hospital and ER admissions within 3 months after procedure.
Measured: 12 weeks post-HoLEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start24 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
- Investigators
- Amy E Krambeck, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580404
- Sponsor's protocol ID
- STU00225227
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 15 Oct 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Emsella for Reducing Transient Stress Urinary Incontinence (tSUI) Following Holmium Laser Enucleation of the Prostate (HoLEP)
- ClinicalTrials.gov ID
- NCT07580404
- Acronym / sponsor ID
- STU00225227
- Conditions
- Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms, Enlarged Prostate (BPH)
- Keywords
- HoLEP, Emsella
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 May 2026 (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.
This study aims to investigate the effectiveness of the Emsella chair treatments at different timepoints. Before and after the holmium laser enucleation of the prostate (HoLEP).
Detailed description
Emsella is a non-invasive treatment used to activate and strengthen the pelvic floor. One Emsella treatment is reported to be the equivalent of performing 11,000 Kegel exercises. This study aims to examine the effectiveness of Emsella chair treatments in reducing the likelihood of tSUI following HoLEP by comparing the outcomes of patients who completed treatments at different points of time around their HoLEP procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care (Kegel Exercises) | No intervention | –Patients are reminded to perform pelvic floor exercises known as Kegel exercises for 3 weeks leading up to their scheduled HoLEP procedure, and continue Kegel exercises for 3 weeks following the HoLEP procedure. |
| Pre-HoLEP Emsella | Active comparator | Device: Emsella chairParticipants will complete 2 30-minute Emsella treatment sessions for 3 weeks (for a total of 6 30-minute Emsella chair treatment sessions) leading up to their scheduled HoLEP procedure. They will undergo the HoLEP 1 week after the final Emsella treatment session. |
| Post-HoLEP Emsella | Active comparator | Device: Emsella chairParticipants will complete 2 30-minute Emsella treatment sessions for 3 weeks (for a total of 6 30-minute Emsella chair treatment sessions) following their scheduled HoLEP procedure. They will begin their first Emsella treatment session 1 week after HoLEP. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prostate sizing 80-150g
- Ability to independently transfer and tolerate all 30min Emsella treatments (e.g. not wheelchair bound, no mobility issues)
- Baseline M-ISI scores <4
- Same-day catheter removal and discharge
- Able to read, understand, and complete surveys and questionnaires
Key exclusion criteria (7 listed)
- Catheter dependence
- Previous BPH procedure
- Previous pelvic surgeries
- Pre-existing pelvic floor dysfunction
- Neurogenic bladder
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 |
|---|---|---|
| Emsella chairEmsella is a non-invasive treatment used to activate and strengthen the pelvic floor. One Emsella treatment is reported to be the equivalent of performing 11,000 Kegel exercises. | Device | Post-HoLEP Emsella, Pre-HoLEP Emsella |
Primary outcome
Difference in Michigan Incontinence Score (M-ISI)
Time frame: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP
The Michigan Incontinence Score (M-ISI) is a 10-item questionnaire designed to assess urinary incontinence type, severity, and bother, with a focus on stress and urge incontinence. The tool is commonly used to screen for clinically relevant symptoms, with a total score of greater than or equal to 7 suggesting a need for intervention.
Difference in International Prostate Symptom Score (IPSS)
Time frame: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP
The International Prostate Symptom Score (IPSS) is a 7-question tool (0-35 points) used in urology to assess Benign Prostatic Hyperplasia (BPH) severity, plus one quality-of-life question. It measures symptoms like frequency, urgency, weak stream, and nocturia, with scores of 0-7 (Mild), 8-19 (Moderate), and 20-35 (Severe).
1 secondary outcome
Difference in safety/adverse effects
Time frame: 12 weeks post-HoLEP
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 15 Oct 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.
Amy E Krambeck, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emsella chair in people with Benign Prostatic Hyperplasia and Enlarged Prostate With Lower Urinary Tract Symptoms, run by Northwestern University 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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 15 Oct 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Michigan Incontinence Score (M-ISI) (time frame: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP). The study lists 2 primary outcomes in all. 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 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.