Overactive Bladder SyndromeNCT06283498
Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder
A study testing Device Morpheus8V in people with Overactive Bladder Syndrome, run by InMode MD Ltd. at 3 sites in 2 countries.
Trial summary
The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder The main questions it aims to answer are: •Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency… Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Device Morpheus8V
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Nov 2023to 10 Nov 2027
- 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 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80 years old, inclusive
- Subject is willing to provide Informed Consent, is geographically stable, understands the requirements for completing the bladder diary and is willing to comply with the required diary, follow-up visits, and testing schedules.
- Urinary incontinence, predominant urgency incontinence for at least one episode on a 3-days diary.
- Reporting at least "moderate bother" on Item 2 on the UDI, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
- >8 micturitions and >3 urgency episodes per 24 hours on a 3-day bladder diary (see Appendix 2)
- 1 UUI episode on a 3-day bladder diary (see Appendix 2)
Show all 10Show fewer
- Not currently taking anti-muscarinic or beta3 agonist therapy (after at least a 2-week wash-out period)
- Post-void residual (PVR) ≤ 100 ml NOTE: it may include Subjects with a single PVR of >100 ml followed by two consecutive PVR measurements of ≤100 ml in the study. We will record the final acceptable PVR measurement in the data.
- Ability and willingness to self-catheterize in case this is necessary.
- With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly from screening until the last follow up
Who cannot join
- Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.
- Any permanent implant or an injected chemical substance in the treatment area.
- Superficial areas that have been injected with HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
- Current or history of cancer, or current condition of any other type of cancer, or premalignant moles.
- Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- Pregnancy, the intention of pregnancy and nursing.
Show all 39Show fewer
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, autoimmune disorders, or use of immunosuppressive medications.
- Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
- Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
- Any active condition in the treatment area, such as sores, eczema, and rash.
- History of vaginal disorders, keloids, abnormal wound healing.
- History of bleeding coagulopathies or use of anticoagulants in the last 10 days, as per the practitioner's discretion.
- Non-English speakers
- Severely impaired mobility or cognition
- Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease
- Repair of pelvic organ prolapse or incontinence procedure in the previous 6 months
- Ongoing complications of prior anti-incontinence surgery
- Received intravesical botulinum injection within the previous 12 months
- History of an implanted nerve stimulator for incontinence
- History of prior sling or vaginal mesh placement,
- Previous diagnosis of interstitial cystitis, bladder cancer, or chronic pelvic pain
- Current participation in any other conflicting interventional or OAB treatment study
- Planning to become pregnant during the study period.
- Pelvic radiation, history of pelvic radiation
- Subject with 24-hour total urine volume voided greater than 3,000 ml as measured at screening period.
- Active urinary tract or vaginal infection
- Anatomical conditions that would prevent the introduction and use of the device, in such as significant pelvic organ prolapse,
- Current hydronephrosis or hydroureter
- Bladder outflow obstruction
- Active pelvic organ malignancy
- Urethral obstruction
- Urinary retention or prolonged catheter use
- Less than 12 months post-partum or currently pregnant or plan to become pregnant in the following 12 months.
- Untreated symptomatic urinary tract infection
- Unevaluated hematuria
- Medical instability
- Allergy to anesthetics as Benzocaine/Lidocaine/Tetracaine Cream (BLT Cream) used in the study
- Not available for follow-up in 6 months
- Participation in other research trials that could influence results of this study
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites
Mickey Karram MD
Corona del Mar, California, 92625
Institute for Female Pelvic Medicine
Knoxville, Tennessee, 37932
Colombia1 site
The Hospital Infantil Universitario de San José (University Children's Hospital of San José)
Bogotá
About this study
The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder
The main questions it aims to answer are:
Read more
•Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. [Time Frame: 3 months]
Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis.
Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Device Morpheus8V
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device Morpheus8VDevice
Assigned to be treated using the modified Morpheus8V
| Study group | Role | What they receive |
|---|---|---|
| Device Treatment | Experimental | 20 female patients with overactive bladder symptoms, aged 21 to 80 years old, inclusive from two sites. Receives: Device: Device Morpheus8V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urgency incontinence episodes after 3 month
Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes.
Measured: 3 months
Secondary outcomes (16)
Change in urgency incontinence episodes after 1 month
Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes
Measured: 1 month
Change in urgency incontinence episodes
Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes.
Measured: 6 months
Change in urgency incontinence episodes
Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes.
Measured: 12 months
Analysis to assess the urinary frequency
Change from baseline to the end of treatment in a 3-day diary analysis to assess the urinary frequency.
Measured: 1 month
Analysis to assess urinary frequency
Change from baseline to the end of treatment in a 3-day diary analysis to assess urinary frequency.
Measured: 3 months
Analysis to assess the urinary frequency.
Change from baseline to the end of treatment in a 3-day diary analysis to assess the urinary frequency. [Time Frame: 6 months]
Measured: 6 months
Analysis to assess the urinary frequency.
Change from baseline to the end of treatment in a 3-day diary analysis to assess the urinary frequency.
Measured: 12 months
Assessment of the impact of the treatment on Overactive Bladder symptoms
Measured by the Incontinence Impact Questionnaire Total Score. Normative values for a general population, 10% of whom scored above 4.8 on IIQ-7. Values obtained from patients with severe incontinence indicate that a score > 70 on the IIQ signifies a poor QOL. Lower scores on IIQ-7 may identify more females who are bothered by urinary incontinence. 7 items are divided into four domains (physical activity, travel, social relationships, emotional health). Item-level scores are rated on a four-point Likert scale (where 0=not at all and 3=greatly), determined by the self-reported impact of symptoms related to urinary incontinence.
The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.
Measured: 1 month
Assessment of the impact of the treatment on Overactive Bladder symptoms
Measured by the Incontinence Impact Questionnaire Total Score. Normative values for a general population, 10% of whom scored above 4.8 on IIQ-7. Values obtained from patients with severe incontinence indicate that a score > 70 on the IIQ signifies a poor QOL. Lower scores on IIQ-7 may identify more females who are bothered by urinary incontinence. 7 items are divided into four domains (physical activity, travel, social relationships, emotional health). Item-level scores are rated on a four-point Likert scale (where 0=not at all and 3=greatly), determined by the self-reported impact of symptoms related to urinary incontinence.
The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.
Measured: 3 months
Assessment of the impact of the treatment on Overactive Bladder symptoms
Measured by the Incontinence Impact Questionnaire Total Score. Normative values for a general population, 10% of whom scored above 4.8 on IIQ-7. Values obtained from patients with severe incontinence indicate that a score > 70 on the IIQ signifies a poor QOL. Lower scores on IIQ-7 may identify more females who are bothered by urinary incontinence. 7 items are divided into four domains (physical activity, travel, social relationships, emotional health). Item-level scores are rated on a four-point Likert scale (where 0=not at all and 3=greatly), determined by the self-reported impact of symptoms related to urinary incontinence.
The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.
Measured: 6 months
Assessment of the impact of the treatment on Overactive Bladder symptoms
Measured by the Incontinence Impact Questionnaire Total Score. Normative values for a general population, 10% of whom scored above 4.8 on IIQ-7. Values obtained from patients with severe incontinence indicate that a score > 70 on the IIQ signifies a poor QOL. Lower scores on IIQ-7 may identify more females who are bothered by urinary incontinence. 7 items are divided into four domains (physical activity, travel, social relationships, emotional health). Item-level scores are rated on a four-point Likert scale (where 0=not at all and 3=greatly), determined by the self-reported impact of symptoms related to urinary incontinence.
The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.
Measured: 12 months
Patient-reported Pain assessment
The subject will be asked to rate the severity from 0 to 10, with 0 equaling no symptoms and 10 equaling the worst possible symptoms. A number is obtained by measuring up to the point the subject has indicated.
Measured: treatment procedure
Patient-reported outcome measure
Patient perception of bladder condition and device acceptance measured by Patient Satisfaction Questionnaire. 6 points Likert scale, grading from 0 to 5. A lower score indicates a better outcome.
Measured: 1 month
Patient-reported outcome measure
Patient perception of bladder condition and device acceptance measured by Patient Satisfaction Questionnaire. 6 points Likert scale, grading from 0 to 5. A lower score indicates a better outcome.
Measured: 3 months
Patient-reported outcome measure
Patient perception of bladder condition and device acceptance measured by Patient Satisfaction Questionnaire. 6 points Likert scale, grading from 0 to 5. A lower score indicates a better outcome.
Measured: 6 months
Patient-reported outcome measure
Patient perception of bladder condition and device acceptance measured by Patient Satisfaction Questionnaire. 6 points Likert scale, grading from 0 to 5. A lower score indicates a better outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start10 Nov 2023
- Primary completion10 Nov 2025 (estimated)
- Study completion10 Nov 2027 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mickey Karram, MD, Principal investigator, Not Affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283498
- Sponsor's protocol ID
- DO612574A
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder
- ClinicalTrials.gov ID
- NCT06283498
- Acronym / sponsor ID
- DO612574A
- Conditions
- Overactive Bladder Syndrome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 28 Feb 2024 (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 goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder
The main questions it aims to answer are:
•Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. [Time Frame: 3 months]
Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis.
Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Treatment | Experimental | Device: Device Morpheus8V20 female patients with overactive bladder symptoms, aged 21 to 80 years old, inclusive from two sites. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 21-80 years old, inclusive
- Subject is willing to provide Informed Consent, is geographically stable, understands the requirements for completing the bladder diary and is willing to comply with the required diary, follow-up visits, and testing schedules.
- Urinary incontinence, predominant urgency incontinence for at least one episode on a 3-days diary.
- Reporting at least "moderate bother" on Item 2 on the UDI, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
- >8 micturitions and >3 urgency episodes per 24 hours on a 3-day bladder diary (see Appendix 2)
Key exclusion criteria (39 listed)
- Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.
- Any permanent implant or an injected chemical substance in the treatment area.
- Superficial areas that have been injected with HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
- Current or history of cancer, or current condition of any other type of cancer, or premalignant moles.
- Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
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 |
|---|---|---|
| Device Morpheus8VAssigned to be treated using the modified Morpheus8V | Device | Device Treatment |
Primary outcome
Change in urgency incontinence episodes after 3 month
Time frame: 3 months
Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes.
16 secondary outcomes
Change in urgency incontinence episodes after 1 month
Time frame: 1 month
Change in urgency incontinence episodes
Time frame: 6 months
Change in urgency incontinence episodes
Time frame: 12 months
Analysis to assess the urinary frequency
Time frame: 1 month
Analysis to assess urinary frequency
Time frame: 3 months
Analysis to assess the urinary frequency.
Time frame: 6 months
Analysis to assess the urinary frequency.
Time frame: 12 months
Assessment of the impact of the treatment on Overactive Bladder symptoms
Time frame: 1 month
Assessment of the impact of the treatment on Overactive Bladder symptoms
Time frame: 3 months
Assessment of the impact of the treatment on Overactive Bladder symptoms
Time frame: 6 months
Assessment of the impact of the treatment on Overactive Bladder symptoms
Time frame: 12 months
Patient-reported Pain assessment
Time frame: treatment procedure
Patient-reported outcome measure
Time frame: 1 month
Patient-reported outcome measure
Time frame: 3 months
Patient-reported outcome measure
Time frame: 6 months
Patient-reported outcome measure
Time frame: 12 months
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 18 Mar 2025.
Related trials for Overactive Bladder Syndrome
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
Overactive Bladder Syndrome, Urinary Incontinence
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.
Mickey Karram, MD principal investigator
Not Affiliated
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device Morpheus8V in people with Overactive Bladder Syndrome, run by InMode MD Ltd. at 3 sites in 2 countries.
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 10 inclusion and 39 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Colombia. 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?
Change in urgency incontinence episodes after 3 month (time frame: 3 months). 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 18 Mar 2025.