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

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.

Conditions

• Vulvodynia
• Vestibulodynia

Interventions

OTHER

Somatocognitive physiotherapy

The main intervention areas include: 1. education about the PVD, healthy vulvo-vaginal and sexual behaviors, nature of chronic pain and factors influencing pain intensity 2. bodily exercises and techniques increasing body awareness, ability to relax and control muscle tension and respiration pattern in different situations 3. techniques to cope with emotions and thoughts related to bodily experiences and to PVD 4. structured homework assignments promoting application of the learned techniques in daily situations and gradual exposure of the patient to activities associated with pain. Participants will be offered maximally 15 treatment sessions. No minimal number of sessions is set. Treatment will be conducted by female physiotherapists experienced in treating long-standing pain conditions.

OTHER

Treatment as usual

The participants will follow the current treatment advice as recommended by the Vulva Clinic at OUH, a tertiary health care center specialized in treatment of vulvar disorders. Advice include guidance about the management of PVD as a condition, use of medication, physiotherapy, sexologist and psychological counseling, usage of internet resources (vulva.no) and others. Participants will be free to pursue treatment options of their choice. The type of treatment, number of treatments and medication usage will be monitored by bi-weekly electronic forms during the whole study period.

Sponsors & Collaborators

• Oslo Metropolitan University

  lead OTHER

Principal Investigators

• Slawomir Wojniusz, Phd · Oslo Metropolitan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Norway

Study Locations