Overactive Bladder Syndrome
Conditions
Brief 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 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.
Interventions
DEVICEDevice Morpheus8V
Assigned to be treated using the modified Morpheus8V
Sponsors
InMode MD Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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) * 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
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in urgency incontinence episodes after 3 month | 3 months | Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis to assess urinary frequency | 3 months | Change from baseline to the end of treatment in a 3-day diary analysis to assess urinary frequency. |
| Analysis to assess the urinary frequency. | 6 months | Change from baseline to the end of treatment in a 3-day diary analysis to assess the urinary frequency. \[Time Frame: 6 months\] |
| Change in urgency incontinence episodes after 1 month | 1 month | Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes |
| Analysis to assess the urinary frequency | 1 month | Change from baseline to the end of treatment in a 3-day diary analysis to assess the urinary frequency. |
| Assessment of the impact of the treatment on Overactive Bladder symptoms | 1 month | 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. |
| Patient-reported Pain assessment | treatment procedure | 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. |
| Patient-reported outcome measure | 1 month | 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. |
| Change in urgency incontinence episodes | 6 months | Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. |
Countries
Colombia, United States
Outcome results
None listed