Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women (NCT07209397)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Stanford Medicine Department of Obstetrics & Gynecology โ Palo Alto, California
Age range: 22 Years to 80 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (9 Sites)
- Stanford Medicine Department of Obstetrics & Gynecology โ Palo Alto, California
- MedStar Health Research Institute โ Washington D.C., District of Columbia
- Advanced Specialty Research โ Boise, Idaho
- University of Chicago Medicine Urogynecology โ Chicago, Illinois
- Cypress Medical Research Center โ Wichita, Kansas
- Bay State Clinical Trials โ Watertown, Massachusetts
- Urology Center, P.C. โ Omaha, Nebraska
- UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics โ Las Vegas, Nevada
- Atrium Health Wake Forest Female Pelvic Health Division โ Winston-Salem, North Carolina
๐ Contact the Study Coordinator
Phone: (573) 300-9185
Email: nicholas@femalehealthawareness.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections โ Cincinnati, Ohio
- Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease โ Decatur, Georgia
- Add-On ZIDA Sock Therapy for Overactive Bladder โ Charleston, South Carolina
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Explore by condition: All Overactive Bladder clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.