Overactive BladderDENARANCT07209397
Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
A study testing Detrusor nerve radiofrequency ablation in people with Overactive Bladder and Overactive Bladder (OAB), run by InMode MD Ltd. at 9 sites in United States.
Trial summary
The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication. This study will include women ages 22 to 80 who have had OAB symptoms for at least 6 months. Read more about this study
- Who is it for?
- Ages 22 to 80 years, women only
- Conditions the study is for
- Overactive Bladder, Overactive Bladder (OAB), Urge Urinary Incontinence
- What is being tested?
- Detrusor nerve radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Nov 2025to 30 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 22 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 22 to 80 years inclusive at the time of consent.
- History of idiopathic overactive bladder (OAB) symptoms for ≥6 months.
- At least 7 episodes of urge urinary incontinence (UUI) over 3 days, as recorded in a 3-day bladder diary during screening.
- Urge-predominant incontinence, defined as greater number of UUI episodes than stress urinary incontinence (SUI) episodes during screening.
- Willing and able to complete the 3-day bladder diary.
- Willing to discontinue OAB medications (e.g., anticholinergics, beta-3 agonists) at least 2 weeks prior to baseline treatment visit, if currently taking such medications.
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- Willing to use a reliable method of contraception during the study period, if of childbearing potential and sexually active.
- Negative pregnancy test at screening (if applicable).
- Willing and able to provide written informed consent and comply with study procedures and follow-up schedule.
Who cannot join
- Predominant stress urinary incontinence (SUI) based on bladder diary
- Currently pregnant, breastfeeding, or planning pregnancy during the study
- History of neurologic conditions affecting bladder function (e.g., multiple sclerosis, spinal cord injury, Parkinson's disease)
- Active urinary tract infection (UTI) at screening
- History of interstitial cystitis, bladder pain syndrome, or chronic pelvic pain
- Prior or current bladder cancer, pelvic malignancy, or pelvic radiation
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- Pelvic organ prolapse beyond the hymen (POP-Q stage > II)
- Implanted neuromodulation device or prior sacral nerve stimulation
- Use of bulking agents, Botox, or surgical treatment for incontinence within 12 months
- Prior pelvic floor RF treatment or laser vaginal rejuvenation
- Significant pelvic anatomical abnormalities that interfere with treatment
- Use of investigational drug or device within 30 days before screening
- Any condition that, in the investigator's opinion, would interfere with safe study participation or data integrity
- Uncontrolled systemic disease (e.g., uncontrolled diabetes, cardiovascular disease)
- Inability or unwillingness to comply with study requirements or follow-up
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Advanced Specialty Research
Boise, Idaho, 83702
Jennifer Poralla, (208)-906-1600, Jennifer@idahoasr.com
Bill Laitinen, MD
- Not yet recruiting
University of Chicago Medicine Urogynecology
Chicago, Illinois, 60062
Rowena Shi, 773-795-2731, jinxuan.shi@bsd.uchicago.edu
Kimberly Kenton, MD
- Not yet recruiting
UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics
Las Vegas, Nevada, 89154
Yamrot Bekele, 702-895-4923, yamrot.bekele@unlv.edu
Yarini Quezada, MD
- Recruiting
Urology Center, P.C.
Omaha, Nebraska, 68114
Amy Nelson, 402-399-7894, anelson@adultpediatricuro.com
Emily Kean-Puccioni, MD
- Not yet recruiting
Stanford Medicine Department of Obstetrics & Gynecology
Palo Alto, California, 94304
Ijeoma Clinical Research Coordinator II, 650-725-0620, ijeomaiw@stanford.edu
Eric Sokol, MD
- Not yet recruiting
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Patricia Senior Clinical Program Manager, 202-877-0486, Patricia.L.Moriarty@medstar.net
Alexis Dieter, MD
- Recruiting
Bay State Clinical Trials
Watertown, Massachusetts, 02472
Alexia DeOliveira, 617-923-0328, deoliveira415@gmail.com
Henry Mitcheson, MD
- Recruiting
Cypress Medical Research Center
Wichita, Kansas, 67226
Addie Hayes, 316-369-0515, addiehayes@cypressmrc.com
Kevin Miller, MD
- Recruiting
Atrium Health Wake Forest Female Pelvic Health Division
Winston-Salem, North Carolina, 27103
Sachin Vyas, 336-713-4098, svyas@wakehealth.edu
Catherine Matthews, MD
About this study
Official title: A Randomized, Prospective, Multicenter, Double-Blind, Sham-Controlled Study to Assess the MORPHEUSV Radiofrequency (RF) Device in the Treatment of Female Patients With Idiopathic Overactive Bladder (OAB) With Urge Incontinence and/or Urge-Predominant Mixed Incontinence
The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication. This study will include women ages 22 to 80 who have had OAB symptoms for at least 6 months. The main questions it aims to answer are: Does the MORPHEUSV device lower the number of daily episodes of accidental urine leakage caused by urgency? Does it work better than a sham (placebo) treatment? Researchers will compare the MORPHEUSV device to a sham treatment to see how well it reduces symptoms of overactive bladder. Participants will: 1) Receive one session of either the MORPHEUSV or sham treatment. 2) Track their symptoms using a diary and questionnaires 3) Return for three to six follow-up visits over 12 months. This study is being conducted at multiple clinics in the United States.
Read the detailed description
Overactive bladder (OAB) is a common condition that significantly impacts the quality of life in women, especially those with urge urinary incontinence (UUI) or mixed incontinence with a predominant urgency component. Current treatments for OAB, including behavioral therapy and pharmacologic agents, often have limited long-term efficacy, tolerability issues, or low adherence rates. There is a significant need for alternative, non-invasive therapies that can provide symptom relief with fewer side effects. The MORPHEUSV system is a vaginally delivered radiofrequency (RF) energy device designed to remodel submucosal tissue through controlled thermal stimulation. This technology is currently being investigated for its ability to improve bladder control by targeting pelvic tissue support and neuromodulation pathways. The device is investigational for this indication and is being studied under an FDA-approved Investigational Device Exemption (IDE G250071). This is a prospective, randomized, multicenter, double-blind, sham-controlled clinical trial designed to evaluate the safety and efficacy of the MORPHEUSV RF device in women aged 22 to 80 with idiopathic OAB and at least 7 episodes of UUI per week. The study will enroll approximately 202 participants at up to 12 sites across the United States. Participants will be randomized 2:1 to either a single session of active RF treatment or a sham (placebo) treatment. The primary outcome is the proportion of participants achieving a ≥50% reduction in UUI episodes from baseline at 6 months. Secondary and exploratory outcomes include symptom reduction across urgency, frequency, nocturia, and quality of life metrics, as well as device-related adverse events. Blinding will be maintained through the use of an identical sham applicator with no RF energy delivery. A crossover option is available for sham subjects who complete the 6-month follow-up, allowing them to receive the active treatment. All participants will be followed for 12 months after their initial intervention to evaluate durability of response and long-term safety. An internal data review committee will periodically evaluate cumulative safety data. The study is conducted under Good Clinical Practice (GCP) guidelines and will be overseen by Sterling IRB.
- Conditions
- Overactive Bladder, Overactive Bladder (OAB), Urge Urinary Incontinence, Mixed Urinary Incontinence (Urge-Predominant), Mixed Urinary Incontinence, Idiopathic Overactive Bladder With Urinary Incontinence
- Being tested
- Detrusor nerve radiofrequency ablation, Simulated (sham) detrusor nerve radiofrequency ablation
- Keywords
- Overactive bladder, Urge urinary incontinence, Mixed urinary incontinence, Female urinary symptoms, urogynecology, Female Urology
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detrusor nerve radiofrequency ablationDevice
A single, vaginal radiofrequency (RF) treatment. The procedure is performed with a bipolar RF applicator and requires no anesthesia. Delivered in a single session in an outpatient setting.
Simulated (sham) detrusor nerve radiofrequency ablationDevice
A simulated (sham) radiofrequency (RF) treatment, but with no energy delivered. The procedure mimics the appearance, duration, and positioning of the active device, without therapeutic effect.
| Study group | Role | What they receive |
|---|---|---|
| MORPHEUSV Treatment Arm | Active comparator | Participants in this arm will receive a single session of radiofrequency (RF) treatment using the MORPHEUSV device. The treatment is delivered vaginally using a bipolar RF applicator at a therapeutic energy setting. No anesthesia is required. Participants will be followed for 12 months to evaluate safety and effectiveness. Receives: Device: Detrusor nerve radiofrequency ablation |
| Sham Control Arm | Sham comparator | Participants in this arm will undergo a procedure using a visually identical MORPHEUSV applicator, but without RF energy delivery (sham). The procedure mimics the appearance and duration of the active treatment. Participants will be followed for 12 months. After completing the 6-month follow-up, they may elect to cross over and receive a single session of the active RF treatment. Receives: Device: Simulated (sham) detrusor nerve radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes
The percentage of participants who achieve at least a 50% reduction from baseline in the number of UUI episodes per week, as recorded in a 7-day bladder diary. This is the primary efficacy endpoint used to evaluate the effectiveness of the MORPHEUSV device compared to sham.
Measured: 6 months post-treatment
Secondary outcomes (6)
Change from baseline in mean number of UUI episodes per week
Mean change in UUI episodes per week from baseline, based on 7-day bladder diary.
Measured: 6 months
Change from baseline in mean number of urgency episodes per week
Mean change in urgency episodes per week from baseline, based on bladder diary.
Measured: 6 months
Change from baseline in mean number of micturitions per 24 hours
Change in average number of daily voids as measured via bladder diary.
Measured: 6 Months
Change from baseline in Incontinence Quality of Life (I-QOL) total score
Mean change from baseline in total score on the Incontinence Quality of Life Questionnaire (I-QOL), a validated 22-item patient-reported outcome measure assessing the impact of urinary incontinence on quality of life. Total scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: 6 Months
Change from baseline in Urgency Perception Scale (UPS) score
Mean change from baseline in urgency perception severity measured using the Urgency Perception Scale (UPS), a validated patient-reported scale assessing urinary urgency severity. UPS scores range from 0 to 3, with higher scores indicating greater urgency severity (worse symptoms).
Measured: 6 Months
Incidence and severity of adverse events
Frequency and severity of treatment-emergent adverse events in each arm, collected at all follow-up visits.
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 posted7 Oct 2025
- Study start25 Nov 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 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 BladderStudies 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
- Participants will be randomized in a 2:1 ratio to receive either a single session of the MORPHEUS V radiofrequency (RF) treatment or a sham procedure. The study uses a parallel assignment model in which participants remain in their assigned group through the 6-month primary endpoint. After completing the 6-month visit, participants in the sham group may elect to cross over and receive the active treatment. All participants will be followed for 12 months from the time of their initial intervention to assess safety and durability of treatment effects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Foundation for Female Health Awareness
- Responsible party
- Sponsor
- Investigators
- Mickey Karram, MD, Study director, Foundation for Female Health Awareness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209397
- Sponsor's protocol ID
- DO614953A
- Acronym
- DENARA
- Status last verified
- Aug 2025
- First submitted
- 1 Oct 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Multicenter, Double-Blind, Sham-Controlled Study to Assess the MORPHEUSV Radiofrequency (RF) Device in the Treatment of Female Patients With Idiopathic Overactive Bladder (OAB) With Urge Incontinence and/or Urge-Predominant Mixed Incontinence
- ClinicalTrials.gov ID
- NCT07209397
- Acronym / sponsor ID
- DENARA / DO614953A
- Conditions
- Overactive Bladder, Overactive Bladder (OAB), Urge Urinary Incontinence, Mixed Urinary Incontinence (Urge-Predominant), Mixed Urinary Incontinence, Idiopathic Overactive Bladder With Urinary Incontinence
- Keywords
- Overactive bladder, Urge urinary incontinence, Mixed urinary incontinence, Female urinary symptoms, urogynecology, Female Urology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Foundation for Female Health Awareness
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 7 Oct 2025 (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 clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication. This study will include women ages 22 to 80 who have had OAB symptoms for at least 6 months. The main questions it aims to answer are: Does the MORPHEUSV device lower the number of daily episodes of accidental urine leakage caused by urgency? Does it work better than a sham (placebo) treatment? Researchers will compare the MORPHEUSV device to a sham treatment to see how well it reduces symptoms of overactive bladder. Participants will: 1) Receive one session of either the MORPHEUSV or sham treatment. 2) Track their symptoms using a diary and questionnaires 3) Return for three to six follow-up visits over 12 months. This study is being conducted at multiple clinics in the United States.
Detailed description
Overactive bladder (OAB) is a common condition that significantly impacts the quality of life in women, especially those with urge urinary incontinence (UUI) or mixed incontinence with a predominant urgency component. Current treatments for OAB, including behavioral therapy and pharmacologic agents, often have limited long-term efficacy, tolerability issues, or low adherence rates. There is a significant need for alternative, non-invasive therapies that can provide symptom relief with fewer side effects. The MORPHEUSV system is a vaginally delivered radiofrequency (RF) energy device designed to remodel submucosal tissue through controlled thermal stimulation. This technology is currently being investigated for its ability to improve bladder control by targeting pelvic tissue support and neuromodulation pathways. The device is investigational for this indication and is being studied under an FDA-approved Investigational Device Exemption (IDE G250071). This is a prospective, randomized, multicenter, double-blind, sham-controlled clinical trial designed to evaluate the safety and efficacy of the MORPHEUSV RF device in women aged 22 to 80 with idiopathic OAB and at least 7 episodes of UUI per week. The study will enroll approximately 202 participants at up to 12 sites across the United States. Participants will be randomized 2:1 to either a single session of active RF treatment or a sham (placebo) treatment. The primary outcome is the proportion of participants achieving a ≥50% reduction in UUI episodes from baseline at 6 months. Secondary and exploratory outcomes include symptom reduction across urgency, frequency, nocturia, and quality of life metrics, as well as device-related adverse events. Blinding will be maintained through the use of an identical sham applicator with no RF energy delivery. A crossover option is available for sham subjects who complete the 6-month follow-up, allowing them to receive the active treatment. All participants will be followed for 12 months after their initial intervention to evaluate durability of response and long-term safety. An internal data review committee will periodically evaluate cumulative safety data. The study is conducted under Good Clinical Practice (GCP) guidelines and will be overseen by Sterling IRB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 2:1 ratio to receive either a single session of the MORPHEUS V radiofrequency (RF) treatment or a sham procedure. The study uses a parallel assignment model in which participants remain in their assigned group through the 6-month primary endpoint. After completing the 6-month visit, participants in the sham group may elect to cross over and receive the active treatment. All participants will be followed for 12 months from the time of their initial intervention to assess safety and durability of treatment effects.
| Arm | Type | Receives |
|---|---|---|
| MORPHEUSV Treatment Arm | Active comparator | Device: Detrusor nerve radiofrequency ablationParticipants in this arm will receive a single session of radiofrequency (RF) treatment using the MORPHEUSV device. The treatment is delivered vaginally using a bipolar RF applicator at a therapeutic energy setting. No anesthesia is required. Participants will be followed for 12 months to evaluate safety and effectiveness. |
| Sham Control Arm | Sham comparator | Device: Simulated (sham) detrusor nerve radiofrequency ablationParticipants in this arm will undergo a procedure using a visually identical MORPHEUSV applicator, but without RF energy delivery (sham). The procedure mimics the appearance and duration of the active treatment. Participants will be followed for 12 months. After completing the 6-month follow-up, they may elect to cross over and receive a single session of the active RF treatment. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female, aged 22 to 80 years inclusive at the time of consent.
- History of idiopathic overactive bladder (OAB) symptoms for ≥6 months.
- At least 7 episodes of urge urinary incontinence (UUI) over 3 days, as recorded in a 3-day bladder diary during screening.
- Urge-predominant incontinence, defined as greater number of UUI episodes than stress urinary incontinence (SUI) episodes during screening.
- Willing and able to complete the 3-day bladder diary.
Key exclusion criteria (15 listed)
- Predominant stress urinary incontinence (SUI) based on bladder diary
- Currently pregnant, breastfeeding, or planning pregnancy during the study
- History of neurologic conditions affecting bladder function (e.g., multiple sclerosis, spinal cord injury, Parkinson's disease)
- Active urinary tract infection (UTI) at screening
- History of interstitial cystitis, bladder pain syndrome, or chronic pelvic pain
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 |
|---|---|---|
| Detrusor nerve radiofrequency ablationA single, vaginal radiofrequency (RF) treatment. The procedure is performed with a bipolar RF applicator and requires no anesthesia. Delivered in a single session in an outpatient setting. | Device | MORPHEUSV Treatment Arm |
| Simulated (sham) detrusor nerve radiofrequency ablationA simulated (sham) radiofrequency (RF) treatment, but with no energy delivered. The procedure mimics the appearance, duration, and positioning of the active device, without therapeutic effect. | Device | Sham Control Arm |
Primary outcome
Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes
Time frame: 6 months post-treatment
The percentage of participants who achieve at least a 50% reduction from baseline in the number of UUI episodes per week, as recorded in a 7-day bladder diary. This is the primary efficacy endpoint used to evaluate the effectiveness of the MORPHEUSV device compared to sham.
6 secondary outcomes
Change from baseline in mean number of UUI episodes per week
Time frame: 6 months
Change from baseline in mean number of urgency episodes per week
Time frame: 6 months
Change from baseline in mean number of micturitions per 24 hours
Time frame: 6 Months
Change from baseline in Incontinence Quality of Life (I-QOL) total score
Time frame: 6 Months
Change from baseline in Urgency Perception Scale (UPS) score
Time frame: 6 Months
Incidence and severity of adverse events
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 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mickey Karram, MD study director
Foundation for Female Health Awareness
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detrusor nerve radiofrequency ablation in people with Overactive Bladder and Overactive Bladder (OAB), run by InMode MD Ltd. at 9 sites 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 15 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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 FFHA Study Manager (573-300-9185, nicholas@femalehealthawareness.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes (time frame: 6 months post-treatment). 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 30 Jan 2026.