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NCT07209397ClinicalTrials.gov

Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

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

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En resumen

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…

De intervención202 participantes buscados9 centros1 país

Categorías

Nefrología y urología96%Obstetricia y ginecología4%

Registrado en 1 registro

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-10-07; recorded start 2025-11-25
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 5 other studies in this databaseCounted from the lead sponsor named in the record (InMode MD Ltd.)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 7 conditions.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre5/8

    Multi-centre: 9 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 202 participants (target), run at 9 sites.

How this score is built
  • Enrolment22/40

    202 participants (target)

  • Site count11/25

    9 sites

  • Country count0/15

    Single country

  • Planned duration7/10

    Planned over about 25 months

  • Sponsor scale2/10

    InMode MD Ltd. has led 6 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

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.

Afecciones

  • Overactive Bladder
  • Overactive Bladder (OAB)
  • Urge Urinary Incontinence
  • Mixed Urinary Incontinence (Urge-Predominant)
  • Mixed Urinary Incontinence
  • Idiopathic Overactive Bladder With Urinary Incontinence
  • Idiopathic Overactive Bladder

Elegibilidad

SexoMujer
Edades22 Years – 80 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseNo aplicable
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción202 participantes buscados

Patrocinador y colaboradores

  • InMode MD Ltd. Patrocinador
  • Foundation for Female Health Awareness Colaboradores

Grupos e intervenciones

  • MORPHEUSV Treatment ArmACTIVE_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.

  • Sham Control ArmSHAM_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.

Intervenciones

  • Dispositivo 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.

  • Dispositivo 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.

Variables de resultado

  1. Variable de resultado principal

    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.

    Plazo 6 months post-treatment

  2. Variable de resultado secundaria

    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.

    Plazo 6 months

  3. Variable de resultado secundaria

    Change from baseline in mean number of urgency episodes per week

    Mean change in urgency episodes per week from baseline, based on bladder diary.

    Plazo 6 months

  4. Variable de resultado secundaria

    Change from baseline in mean number of micturitions per 24 hours

    Change in average number of daily voids as measured via bladder diary.

    Plazo 6 Months

  5. Variable de resultado secundaria

    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.

    Plazo 6 Months

  6. Variable de resultado secundaria

    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).

    Plazo 6 Months

  7. Variable de resultado secundaria

    Incidence and severity of adverse events

    Frequency and severity of treatment-emergent adverse events in each arm, collected at all follow-up visits.

    Plazo 12 Months

Fechas

Fecha de inicio25 de noviembre de 2025 (real)
Finalización principal30 de junio de 2027 (estimada)
Finalización30 de noviembre de 2027 (estimada)
Primera publicación7 de octubre de 2025 (real)
Última actualización30 de enero de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezagosto de 2025

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

5 centros están en reclutamiento

United States

CentroCiudadEstado o regiónEstado
Advanced Specialty ResearchBoiseIdahoEn reclutamiento
University of Chicago Medicine UrogynecologyChicagoIllinoisAún no recluta
UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & ObstetricsLas VegasNevadaAún no recluta
Urology Center, P.C.OmahaNebraskaEn reclutamiento
Stanford Medicine Department of Obstetrics & GynecologyPalo AltoCaliforniaAún no recluta
MedStar Health Research InstituteWashington D.C.District of ColumbiaAún no recluta
Bay State Clinical TrialsWatertownMassachusettsEn reclutamiento
Cypress Medical Research CenterWichitaKansasEn reclutamiento
Atrium Health Wake Forest Female Pelvic Health DivisionWinston-SalemNorth CarolinaEn reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07209397