Effectiveness and Cost-utility of Somatocognitive Therapy Versus Treatment as Usual for Provoked (Localized) Vestibulodynia - a Randomized Clinical Trial (ProLoVe Study)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a two-arm randomized clinical trial assessing effectiveness of somatocognitive therapy versus treatment as usual for provoked vestibulodynia (PVD). PVD is a common, but under-treated persistent pain condition, mostly affecting young women in their late teens and early 20s. It is the most frequent cause of pain during sexual intercourse affecting around 10% of women in the general population. There are no generally accepted evidence-based guidelines for the medical management of PVD. The most commonly used treatments are topical (85%), physiotherapy (52%), and oral medications (45%). High quality randomized clinical trials testing effectiveness of various therapy approaches are urgently needed. Somatocognitive therapy SCT is a multi-modal physiotherapy approach developed for alleviating musculoskeletal persistent pain conditions. SCT has been previously evaluated in the treatment of women with chronic pelvic pain. In the current study, 128 women with PVD will be randomized into SCT and treatment as usual (TAU) group. Participants will be assessed at baseline, after 6 months and after 12 months. The main outcome will be changes in female sexual function index scored at 12 months follow up. Secondary outcomes include pain intensity as assessed by a tampon test as well as a number of questionnaires recording different aspects of emotional and cognitive functioning. In addition cost-effectiveness analysis of SCT versus TAU will be performed. Participants in the SCT group will receive up to 15 therapy sessions and will additionally be offered one booster session at 6 months after treatment ending. TAU group will follow treatment options of their own choice based on recommendations from the Vulva clinic at Oslo University Hospital, a center that is specialized in treating women with vulvar pain conditions.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Oslo Metropolitan University
RECRUITING
Oslo
Contact Information
Primary
Slawomir Wojniusz, Phd
slawomir@oslomet.no
+47 419 26 564
Backup
Mette B Kaarbø, Msc
metteboy@oslomet.no
+47 974 11 669
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 128
Treatments
Experimental: Somatocognitive physiotherapy
Somatocognitive therapy is a multi-modal physiotherapy intervention utilized for women with longstanding chronic pelvic pain and provoked vestibulodynia developed at the beginning of the 2000s as a collaboration between the department of psychosomatic medicine, Oslo University Hospital (OUH) and department of physiotherapy (OsloMet)
Active_comparator: Treatment as usual
The participants randomized to the treatment as usual group will follow available treatment options based on the current recommendations from Vulva clinic at Oslo University Hospital, a center that is specialized in treatment of vulvar conditions.
Related Therapeutic Areas
Sponsors
Leads: Oslo Metropolitan University

This content was sourced from clinicaltrials.gov