An interventional study of Detrusor nerve radiofrequency ablation and Simulated (sham) detrusor nerve radiofrequency ablation in Overactive Bladder, Overactive Bladder (OAB) and Urge Urinary Incontinence, sponsored by InMode MD Ltd.. Recruiting at 9 sites in United States. Open to female participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by InMode MD Ltd. (part of InMode Ltd.) · Not applicable, Interventional, and Treatment
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Among 333 studies in Urinary Bladder, Overactive with a site in United States — 40 open to participants now, 48 under way, 2 of them phase 3. Urinary Bladder, Overactive · United States.
Among the 333 studies in Urinary Bladder, Overactive with a site in United States, this one is the 74th largest by planned enrollment of the 288 interventional ones that give a count, is one of 14 that started in 2025, is one of 113 with no phase, reaches primary completion later than 30 of the 47 other live ones, and was the 320th registered.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 126 are open to participants now.
Browse Urinary Bladder, Overactive studies →40 of the 333 studies in Urinary Bladder, Overactive with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 21+ · Women only
Vensica Therapeutics Ltd. · Sites in United States
Ages 18–80 · Women only
The Cleveland Clinic · Sites in United States
Ages 18+ · Women only
Loma Linda University · Sites in United States
Ages 18–89
Stimuli Technology · Sites in United States, Canada
Ages 22+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 73 Urinary Bladder, Overactive studies recruiting now, 44 (60%) set no upper age limit and 15 (21%) stop at 75 or younger; 6 take children under 18; 8 take healthy volunteers.
This study: 22 Years to 80 Years · female · no healthy volunteers.
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333 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 26 · Phase 2 35 · Phase 3 52 · Phase 4 71
First in 2002; this study’s year is marked. 14 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 202 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Median enrollment 66 across the 288 interventional studies, 91 across the 43 observational. Of the 259 that completed or were terminated, 134 (52%) have results posted.
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153 of 333 have an industry lead sponsor. The 10 most frequent:
This study is registered under InMode MD Ltd., one of the names counted as InMode Ltd.. Under that name alone:
InMode MD Ltd. is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.
InMode Ltd. has 3 studies filed under Urinary Bladder, Overactive — fewer than ten, so there is no comparison to draw.
19 of the studies in Urinary Bladder, Overactive with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06797245Medstar Health Research InstituteAPPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women | 2026-11 |
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT07335484Axonics, Inc.Aquarius Pilot Study to Evaluate the New Axonics Trial System | 2026-11 |
| NCT07405554Endeavor HealthZinc Supplementation With Botulinum Toxin for Overactive Bladder | 2026-12 |
| NCT05200923MedtronicNeuroPelvic Health Electrically Evoked Recording (PEER) 2 Study | 2026-12-18 |
Add all 19 to your calendar (.ics) → With an account.
Among the 333 studies in Urinary Bladder, Overactive with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Detrusor nerve radiofrequency ablation
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.
Device: Simulated (sham) 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.
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.
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.
Time frame: 6 months post-treatment
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.
Time frame: 6 months
Change from baseline in mean number of urgency episodes per week
Mean change in urgency episodes per week from baseline, based on bladder diary.
Time frame: 6 months
Change from baseline in mean number of micturitions per 24 hours
Change in average number of daily voids as measured via bladder diary.
Time frame: 6 Months
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.
Time frame: 6 Months
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).
Time frame: 6 Months
Incidence and severity of adverse events
Frequency and severity of treatment-emergent adverse events in each arm, collected at all follow-up visits.
Time frame: 12 Months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jun 2027, 19 months after the start.
Of 41 industry-sponsored interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's planned 19 months is above that.
Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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