BridgeMD
Tests treatment safety and results for Genitourinary Syndrome of Menopause (GSM)
Official title Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)
ClinicalTrials.gov ID: NCT07034976
What this study is testing
- What it's testing
- The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those symptoms. The main questions it aims to answer are: Does the combination of RF + exercise lower the 0-to-10 vaginal-dryness score more than sham (inactive) RF + exercise at 6 weeks (end of treatment) and 3 months?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.
- Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a...
- Negative urine culture at baseline.
- Moderate to severe vaginal dryness, defined as a score \> 4 on the Numeric Rating Scale (NRS 0-10)
You likely can't join if
- Age over 75 years.
- Current or past diagnosis of any cancer other than breast cancer.
- Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months.
- Use of local estrogen therapy within the past month.
- Active genital infections.
- Diagnosis of HIV infection or severe immunosuppression.
See the full eligibility criteria
- Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.
- Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physician. Symptoms must be bothersome and not better explained by another...
- Negative urine culture at baseline.
- Moderate to severe vaginal dryness, defined as a score \> 4 on the Numeric Rating Scale (NRS 0-10)
- Age over 75 years.
- Current or past diagnosis of any cancer other than breast cancer.
- Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months.
- Use of local estrogen therapy within the past month.
- Active genital infections.
- Diagnosis of HIV infection or severe immunosuppression.
- Presence of pacemakers, metallic implants, or electromagnetic devices.
- Coagulation disorders or current use of anticoagulants.
- Pelvic organ prolapse stage \> III (POP-Q classification).
- Unexplained abnormal vaginal bleeding.
- History of pelvic anti-incontinence surgery, with or without mesh.
- Inflammatory dermatoses of the vulva.
- Pelvic-floor muscle strength score of 0/5 on the Modified Oxford Scale.
- Nickel allergy.
- Previous treatment with radiofrequency in the pelvic or genital area.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.