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Search / Trial NCT06460415

Effects of Photobiomodulation on Pain and Sexual Function in Women With Dyspareunia: Randomized Clinical Trial

Launched by FEDERAL UNIVERSITY OF HEALTH SCIENCE OF PORTO ALEGRE · Jun 11, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Photobiomodulation Dyspareunia Sexual Dysfunction Physiotherapy Pelvic Pain

ClinConnect Summary

This clinical trial is studying the effects of a treatment called photobiomodulation (PBM) on women who experience painful intercourse, a condition known as dyspareunia. The researchers want to find out if applying PBM to specific areas in the vulvar and vaginal regions can help reduce pain and improve sexual function compared to a group that receives a simulated (sham) treatment. They will measure the results immediately after treatment and again at follow-up appointments over the next six months to see if there are any lasting benefits.

To participate, women aged 18 to 45 who have been experiencing pain during intercourse for at least six months and score their pain as moderate to severe on a pain scale may be eligible. However, women with certain health conditions, such as serious illnesses or those currently pregnant or breastfeeding, cannot participate. During the trial, participants will receive eight applications of the PBM treatment over eight days. This study aims to provide important insights into a potential new way to alleviate pain and improve quality of life for women facing these challenges.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Women, aged between 18 and 45 years classified with dyspareunia criteria, according to the guidelines of the European Association of Urology guideline (2022)2, who report pain in relationship greater than 3 on the visual numeric pain scale at the beginning of participation in the research , who present sensitivity to unidigital palpation of the pelvic muscular wall (e.g., levator ani, coccygeus, obturator) and who report feeling pain during penetration for at least 6 months.
  • Exclusion Criteria:
  • Women with a history of neurological or oncological diseases or bone fractures in the pelvic region, in addition to radiculopathies, decompensated heart disease or metabolic disorders, pregnant women, lactating women, women in menopause, women with difficulties in understanding written or spoken language, in use of photosensitizing drugs, who present an inflammatory condition or have used anti-inflammatories on the day of the evaluation, red flags (post-coital bleeding, abrupt unexplained weight loss, presence of a mass visible on ultrasound, macroscopic or microscopic hematuria), who have a diagnosis of painful bladder syndrome, irritable bowel syndrome, interstitial cystitis, fibromyalgia. Who have a history of spine surgery or have undergone any surgical intervention with general anesthesia in the last 120 days. Who is currently undergoing pelvic physiotherapy treatment.

About Federal University Of Health Science Of Porto Alegre

The Federal University of Health Science of Porto Alegre (UFCSPA) is a distinguished academic institution in Brazil, dedicated to advancing healthcare education, research, and clinical practice. Renowned for its commitment to excellence in medical and health sciences, UFCSPA plays a pivotal role in fostering innovation through rigorous clinical trials and collaborative research initiatives. The university's research programs are designed to address pressing health challenges, enhance patient care, and contribute to the scientific community, ensuring that findings translate into meaningful health solutions. With a multidisciplinary approach and a focus on ethical standards, UFCSPA is at the forefront of improving health outcomes both locally and globally.

Locations

Porto Alegre, Rs, Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported