Recruiting

MORPHEUSV

Sponsor:

InMode MD Ltd.

Code:

NCT07209397

Conditions

Overactive Bladder

Overactive Bladder (OAB)

Urge Urinary Incontinence

Mixed Urinary Incontinence (Urge-Predominant)

Mixed Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Detrusor nerve radiofrequency ablation

Simulated (sham) detrusor nerve radiofrequency ablation

Study Details

Brief 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. 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.

Conditions

Overactive Bladder

Overactive Bladder (OAB)

Urge Urinary Incontinence

Mixed Urinary Incontinence (Urge-Predominant)

Mixed Urinary Incontinence

Study ID

NCT07209397

Start date

Nov 25, 2025

Status verified date

Aug, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22 - 70+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

  • 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.
  • 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.

EXCLUSION CRITERIA:

  • 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
  • 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

Study Design

Enrollment

202 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: MORPHEUSV Treatment Arm

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.

sham comparator: Sham Control Arm

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.

Interventions

Detrusor nerve radiofrequency ablation

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 ablation

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.

Primary outcome measure

  • Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes [ Time Frame: 6 months post-treatment ]

Central Contacts and Locations

Central contacts

FFHA Study Manager

573-300-9185nicholas@femalehealthawareness.org

Locations

Advanced Specialty Research

Recruiting

Boise, Idaho, United States, 83702

Contacts

Jennifer Poralla

(208)-906-1600Jennifer@idahoasr.com

Principal Investigator:

Bill Laitinen, MD

Cypress Medical Research Center

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Addie Hayes

316-369-0515addiehayes@cypressmrc.com

Principal Investigator:

Kevin Miller, MD

Bay State Clinical Trials

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

Alexia DeOliveira

617-923-0328deoliveira415@gmail.com

Principal Investigator:

Henry Mitcheson, MD

Urology Center, P.C.

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Amy Nelson

402-399-7894anelson@adultpediatricuro.com

Principal Investigator:

Emily Kean-Puccioni, MD

Atrium Health Wake Forest Female Pelvic Health Division

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Sachin Vyas

336-713-4098svyas@wakehealth.edu

Principal Investigator:

Amr Sherif El Haraki, MD

More Information

Sponsor

InMode MD Ltd.

Last update posted

Jan 30, 2026

Last verified

Aug, 2025

Keywords

  • Overactive bladder
  • Urge urinary incontinence
  • Mixed urinary incontinence
  • Female urinary symptoms
  • urogynecology
  • Female Urology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by InMode MD Ltd. on 2026-01-30.