Effects of four non-invasive Neuromodulation methods on Sexual Diseases : randomized clinical trial

Analysis of the neurophysiological and biomechanical effects of four methods of non-invasive Neuromodulation in Sexual Diseases: randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-10rmpmtn

Enrollment

Unknown

Registered

2024-02-12

Start date

2023-12-20

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspareunia

Interventions

This is a multi-arm, double-blind, randomized clinical trial with a quantitative approach and proportional allocation of subjects (1:1). All groups will receive treatment for five days, with experimen

E02.190.599

E02.331.800

F02.463.551

E02.331.900

Eligibility

Sex/Gender

Female

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: women aged between 20 and 45 years; who report a persistent or recurrent complaint for at least six months of at least one of the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Appendix C), 5th edition of the American Psychiatric Association (2014), namely: 1) significant pain during intercourse or penetration attempts; 2) significant fear or anxiety about pain in anticipation of, during, or because of vaginal penetration; 3) stiffness or significant tightening of the pelvic floor muscles during attempts to penetrate the vagina, which represents significant suffering due to the presence of one of these criteria

Exclusion criteria

Exclusion criteria: women who are being treated for pelvic genital pain/penetration with the administration of anesthetic creams in the vulvovaginal region; urinary tract infection; history of epileptic or convulsive conditions; who use drugs to treat epilepsy; presence of metal implants, trauma or surgery in the head and/or neck region; intellectual disability; pregnancy; alcohol and hallucinogenic drug abuse in the last six months; who are undergoing cancer treatment with radiotherapy; and women who miss some day of the therapy proposed in this study

Design outcomes

Primary

Measure	Time frame
It is expected to find a significant improvement in the pain sensation in the participants of the G1 group, when compared to the G2, G3, G4 and GC. And that this improvement in pain has a positive impact on the sexual function of these women. In addition, to bring reflections to the scientific community on new means of treatment for the area of ??women's/pelvic health, which promote confidence, comfort and shorter treatment time for patients with Dor Gênito Pélvica Penetração.	—

Measure

Time frame

It is expected to find a significant improvement in the pain sensation in the participants of the G1 group, when compared to the G2, G3, G4 and GC. And that this improvement in pain has a positive impact on the sexual function of these women. In addition, to bring reflections to the scientific community on new means of treatment for the area of ??women's/pelvic health, which promote confidence, comfort and shorter treatment time for patients with Dor Gênito Pélvica Penetração.

—

Secondary

Measure	Time frame
No secondary outcomes are expected.	—

Countries

Brazil

Contacts

Public ContactLays Anorina Carvalho

Universidade Estadual da Paraíba

laysanorina@gmail.com+55 (83) 999370360

Outcome results

None listed

Source: REBEC (via WHO ICTRP)