Actively Recruiting
Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder
Led by Centro de Atenção ao Assoalho Pélvico · Updated on 2024-05-29
56
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress.
CONDITIONS
Official Title
Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with genito-pelvic pain disorder associated to penetration.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, Brazil, 40.290-000
Actively Recruiting
Research Team
T
Tuffy Mamede, Post-graduation
CONTACT
P
Patrícia Lordelo, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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