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Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder

NCT07279142 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-12

No results posted yet for this study

Summary

The investigator hypothesizes that controlled delivery of low heat (45-50 Centigrade) to the sub-detrusor and detrusor muscle can ablate the autonomic nerve endings and control overactive bladder symptoms without causing significant damage to the surrounding structures. Low heat in such a manner is below urethral sensation and enables office treatment. The transvaginal approach is non-invasive and improves overactive bladder (OAB) symptoms and patients' quality of life. The investigator believes that the RF administration results could be equal or better for first-line treated patients compared to pharmacological refractory patients.

Conditions

  • Overactive Bladder (OAB)
  • Incontinence, Urge

Interventions

DEVICE

Radiofrequency

According to the study protocol, eligible subjects will receive one treatment within 3 weeks of screening. After one month, if there is no satisfactory result, a second treatment will be administered, and after another month, the patient will be evaluated. If there is still no end point, a third treatment will be given. It should be noted that the second and third treatments will only be performed if there is no satisfactory result after the previous treatment. Treatment area: Treatment area will include vaginal canal. Treatment Procedure: * Subjects receive HYPNOS treatment with device using radiofrequency (RF). Treat vaginal canal at the depth starting from approximately 3.5cm from introitus to the distal end of vagina. Radially the treatment area is from 9 to 3 o'clock. * Patient should empty bladder prior to treatment * Position patient in lithotomy position * Set energy to levels well tolerated by the subject. Suggested settings: Burst Mode 7mm, 1 pass.

Sponsors & Collaborators

  • Università della Campania Luigi Vanvitelli

    collaborator UNKNOWN

  • IRCCS San Raffaele

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2026-11-13
Completion
2026-12-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279142 on ClinicalTrials.gov