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Search / Trial NCT04613713

Somatocognitive Therapy in Treatment of Provoked (Localized) Vestibulodynia - Randomized Clinical Trial (ProLoVe Study)

Launched by OSLO METROPOLITAN UNIVERSITY · Nov 2, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Provoked Vestibulodynia Dyspareunia Somatocognitive Therapy Physiotherapy Randomised Clinical Trial Women's Health Sexual Dysfunction Pain Management

ClinConnect Summary

The ProLoVe Study is a clinical trial investigating a new treatment called somatocognitive therapy (SCT) for women with a painful condition known as provoked vestibulodynia (PVD). PVD is a type of chronic pain that primarily affects younger women, causing discomfort during sexual intercourse. This study compares SCT, a specialized physiotherapy approach aimed at relieving this type of pain, with traditional treatments that women usually choose on their own. The trial will involve 128 women aged 18 to 35 who have been diagnosed with PVD. Participants will be assessed at the beginning of the study, and then again after 6 and 12 months to see how their pain and sexual function improve.

Women who join the SCT group will receive up to 15 therapy sessions, with an additional session offered six months later for extra support. The traditional treatment group will follow their own treatment plans based on recommendations from a specialized clinic in Oslo. To participate in this trial, women must not have any active infections or serious skin issues in the vulvar area, and they need to understand Norwegian well enough to fill out questionnaires. This study is important because it seeks to provide better treatment options for PVD, a condition that currently lacks clear guidelines and effective therapies.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Clinical diagnosis of provoked vestibulodynia
  • Age: 18 to 35
  • Must understand Norwegian well enough to be able to complete questionnaires
  • Must be able to attend treatment in Oslo, Norway
  • Exclusion Criteria:
  • Active infection in the vulvar region
  • Dermatologic lesion in the vulvar region
  • Presence of diagnostically confirmed psychiatric condition that necessitate treatment by a medical specialist in psychiatry of clinical psychology

About Oslo Metropolitan University

Oslo Metropolitan University (OsloMet) is a leading institution in Norway dedicated to advancing research and education in various fields, including health sciences, social sciences, and technology. With a strong commitment to fostering innovation and collaboration, OsloMet plays a pivotal role in conducting clinical trials that aim to improve healthcare outcomes and address pressing societal challenges. The university's interdisciplinary approach leverages expertise from diverse domains, ensuring robust methodologies and comprehensive analyses in its research initiatives. OsloMet is dedicated to contributing to evidence-based practices and enhancing the quality of life through its clinical research efforts.

Locations

Oslo, , Norway

Patients applied

0 patients applied

Trial Officials

Slawomir Wojniusz, Phd

Principal Investigator

Oslo Metropolitan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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