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NCT06303609: Pelvic Pain

Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder

Recruiting now NA Last updated 29 May 2024
What this trial tests

NA trial testing nonablative radiofrequency in Pelvic Pain in 56 participants. Currently enrolling.

Timeline
20 April 2024
Primary endpoint
20 June 2026
20 July 2026

Quick facts

Lead sponsorCentro de Atenção ao Assoalho Pélvico
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment56
Start date20 April 2024
Primary completion20 June 2026
Estimated completion20 July 2026
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Centro de Atenção ao Assoalho Pélvico

Who can join

Adults 18 to 45, female only, with Pelvic Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Pelvic Pain

Currently open trials in the same condition.

Other Centro de Atenção ao Assoalho Pélvico trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06303609.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing