Overactive BladderNCT06458556
Transvaginal Radiofrequency Ablation for Overactive Bladder
A study testing Treatment with Morpheus in people with Overactive Bladder, run by InMode MD Ltd. at 1 site in United States.
Trial summary
To assess the effectiveness of transvaginal radiofrequency oblation by the Morpheus device at varying depths of penetration for improving urge predominate and urinary incontinence symptoms in women with overactive bladder . Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Treatment with Morpheus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-85 years old
- Urinary incontinence for ≥ 3 months
- Reporting at least "moderate bother" on Item 2 on the Urinary Distress Inventor questioner, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
- If mixed urinary incontinence, urge is reported predominant symptom on MESA score.
- >10 micturition per 24 hours and >3 urgency episodes on 3-ay bladder diary
- > 1 UUI episode on 3-day bladder diary
- Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2-week wash-out period)
Who cannot join
- 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 in the previous 6 months
- Received intravesical botulinum injection within the previous 12 months
- History of implanted nerve stimulator for incontinence
Show all 19Show fewer
- History of prior sling or vaginal mesh placement, UNLESS onset of UUI was completely unrelated to placement and severity was unaffected by mesh placement.
- Previous diagnosis of Interstitial cystitis
- Active pelvic organ malignancy
- History of pelvic radiation
- Urethral obstruction
- Urinary retention or prolonged catheter use
- Less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months
- Untreated symptomatic urinary tract infection
- Unevaluated hematuria
- Medical instability
- Allergy to anesthetics 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
1 site in 1 country.
United States1 site
California Center for Pelvic Floor Disorders
Corona del Mar, California, 92625
About this study
Official title: Transvaginal Radiofrequency Ablation With Morpheus Device for Treatment of Overactive Bladder.
To assess the effectiveness of transvaginal radiofrequency oblation by the Morpheus device at varying depths of penetration for improving urge predominate and urinary incontinence symptoms in women with overactive bladder .
- Conditions
- Overactive Bladder
- Being tested
- Treatment with Morpheus
- 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.
Treatment with MorpheusDevice
Radiofrequency device treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Morpheus | Experimental | Not described Receives: Device: Treatment with Morpheus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms
Measured by The Urogenital Distress Inventory-6 (UDI-6). The Urogenital Distress Inventory-6 (UDI-6) assesses the severity of urogenital symptoms through six questions addressing frequent urination, urgency-related leakage, leakage during physical activity, small amounts of leakage, difficulty emptying the bladder, and pain or discomfort in the lower abdomen or genital region.
0 = Not at all
- = Slightly
- = Moderately
- = Greatly The scores for each item are summed to give a total score, which ranges from 0 to 18. Higher scores indicate greater distress and symptom severity.
Measured: 3 months
To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence 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
Secondary outcomes (3)
To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life
Measured by The Urogenital Distress Inventory-6 (UDI-6). The Urogenital Distress Inventory-6 (UDI-6) assesses the severity of urogenital symptoms through six questions addressing frequent urination, urgency-related leakage, leakage during physical activity, small amounts of leakage, difficulty emptying the bladder, and pain or discomfort in the lower abdomen or genital region.
0 = Not at all
- = Slightly
- = Moderately
- = Greatly The scores for each item are summed to give a total score, which ranges from 0 to 18. Higher scores indicate greater distress and symptom severity.
Measured: 6 months
To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life
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.
To assess the effectiveness of RF ablation assess on urgency and associated life impact
Measured by the Medical, Epidemiologic, and Social Aspects of Aging (MESA ).The MESA questionnaire is consisted of 2 separate parts, with 6 questions concerning urgency urinary incontinence (UUI) and 9 concerning stress urinary incontinence (SUI).
MESA SI (Stress Incontinence), theoretical scores ranged from 1 (mild) to 27 (severe).
MESA UI (Urgency Incontinence), theoretical scores ranged from 1 (mild) to 18 (severe).
Higher scores indicate more severe symptoms,
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start19 Jun 2023
- Primary completion30 May 2024
- Study completion30 May 2024
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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-blinded non-comparative pilot trial in which a total of 20 subjects with OAB are included. Subjects may include individuals with overactive balder and contraindications to alternative first- and second-line treatments, OAB and do not desire pursuing alternative first- and second-line treatments, refractory overactive balder, and urge predominate mixed urinary incontinence. Subjects will undergo treatment with the Morpheus system every 4 weeks for a total of 3 treatments. Follow up will occur at 3- month and 6-month intervals after the subjects first treatment.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
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
- NCT06458556
- Sponsor's protocol ID
- DO613705A
- Status last verified
- May 2024
- First submitted
- 4 Jun 2024
- Last updated
- 13 Jun 2024
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Radiofrequency Ablation With Morpheus Device for Treatment of Overactive Bladder.
- ClinicalTrials.gov ID
- NCT06458556
- Acronym / sponsor ID
- DO613705A
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 13 Jun 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.
To assess the effectiveness of transvaginal radiofrequency oblation by the Morpheus device at varying depths of penetration for improving urge predominate and urinary incontinence symptoms in women with overactive bladder .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-blinded non-comparative pilot trial in which a total of 20 subjects with OAB are included. Subjects may include individuals with overactive balder and contraindications to alternative first- and second-line treatments, OAB and do not desire pursuing alternative first- and second-line treatments, refractory overactive balder, and urge predominate mixed urinary incontinence. Subjects will undergo treatment with the Morpheus system every 4 weeks for a total of 3 treatments. Follow up will occur at 3- month and 6-month intervals after the subjects first treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment with Morpheus | Experimental | Device: Treatment with Morpheus |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-85 years old
- Urinary incontinence for ≥ 3 months
- Reporting at least "moderate bother" on Item 2 on the Urinary Distress Inventor questioner, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
- If mixed urinary incontinence, urge is reported predominant symptom on MESA score.
- >10 micturition per 24 hours and >3 urgency episodes on 3-ay bladder diary
Key exclusion criteria (19 listed)
- 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 in the previous 6 months
- Received intravesical botulinum injection within the previous 12 months
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 |
|---|---|---|
| Treatment with MorpheusRadiofrequency device treatment | Device | Treatment with Morpheus |
Primary outcome
To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms
Time frame: 3 months
Measured by The Urogenital Distress Inventory-6 (UDI-6). The Urogenital Distress Inventory-6 (UDI-6) assesses the severity of urogenital symptoms through six questions addressing frequent urination, urgency-related leakage, leakage during physical activity, small amounts of leakage, difficulty emptying the bladder, and pain or discomfort in the lower abdomen or genital region. 0 = Not at all 1. = Slightly 2. = Moderately 3. = Greatly The scores for each item are summed to give a total score, which ranges from 0 to 18. Higher scores indicate greater distress and symptom severity.
To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms
Time frame: 3 months
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.
3 secondary outcomes
To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life
Time frame: 6 months
To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life
Time frame: 6 months.
To assess the effectiveness of RF ablation assess on urgency and associated life impact
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
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. This study is not recruiting at the moment.
Mickey Karram, MD principal investigator
Not affiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with Morpheus in people with Overactive Bladder, run by InMode MD Ltd. 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 7 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: finished, as of the sponsor's last update on 13 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms (time frame: 3 months). 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 13 Jun 2024.