Non-ablative radiofrequency treatment for pelvic pain in women
Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder: Randomized Clinical Trial
This study is testing a new non-invasive treatment for pelvic pain in women to see if it can help reduce pain during sex and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Centro de Atenção ao Assoalho Pélvico Academic / other |
| Locations | 1 site (Salvador, Estado de Bahia) |
| Trial ID | NCT06303609 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of non-ablative radiofrequency in treating genito-pelvic pain disorders in women, particularly those experiencing pain during penetration. Participants will be randomly assigned to either the experimental group receiving the treatment or a sham group. The study will assess changes in pain levels and sexual function using validated questionnaires and pelvic floor evaluations before, immediately after, and at intervals up to six months post-treatment. The goal is to determine if this non-invasive approach can alleviate symptoms and improve quality of life for affected women.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with genito-pelvic pain disorder associated with penetration.
Not a fit: Patients with chronic degenerative diseases, cognitive impairments, or those who have undergone treatments for genito-pelvic pain disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pelvic pain and improve sexual function for women suffering from genito-pelvic pain disorders.
How similar studies have performed: While there is limited data on non-ablative radiofrequency specifically for this condition, similar non-invasive treatments have shown promise in managing pelvic pain in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with genito-pelvic pain disorder associated to penetration. Exclusion Criteria: * Chronic degenerative disease * Cognitive impairment * Genital agenesis * History of vaginal cancer or genital radiotherapy * Pelvic or lumbosacral prostheses * Cardiac pacemakers * Pregnant women * Infections in the genital or systemic region * Any type of treatment for genito-pelvic pain disorder * Unstable relationship with the same partner * Partner with sexual complaints.
Where this trial is running
Salvador, Estado de Bahia
- Centro de Atenção ao Assoalho Pelvico — Salvador, Estado de Bahia, Brazil (Recruiting)
Study contacts
- Study coordinator: Tuffy Mamede, Post-graduation
- Email: tuffy@tuffymamede.com
- Phone: +5571999673967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.