Transvaginal Radiofrequency Ablation for Overactive Bladder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-19

Study Completion Date

2024-05-30

Brief Summary

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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 .

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with Morpheus

Group Type EXPERIMENTAL

Treatment with Morpheus

Intervention Type DEVICE

Radiofrequency device treatment

Interventions

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Treatment with Morpheus

Radiofrequency device treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes