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ACTIVE NOT RECRUITING
NCT03640624
NA

Multidisciplinary Treatment of Chronic Vulvar Pain

Sponsor: Norwegian University of Science and Technology

View on ClinicalTrials.gov

Summary

Vulvodynia (i.e. chronic vulvar pain without identifiable cause) is a heterogeneous clinical entity with a complex multifactorial causation. It is long lasting and difficult to treat, and the general consensus of current guidelines states that patients with vulvodynia benefit from a compound multidisciplinary intervention targeting mucosal hypersensitivity, pelvic muscle floor dysfunction and general pain management. However, there is little empiric evidence to support this recommendation. This will be a randomized controlled trial comparing multidisciplinary treatment with standard care for women with vulvodynia.

Official title: Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2018-09-18

Completion Date

2027-06

Last Updated

2025-12-12

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Multidisciplinary treatment

1. Assessment by gynaecologist and dermatologist, resulting in tailored vulvar care, including daily topical lidocaine 5% ointment. Other topical or oral medication, such as oestradiol cream or oral antidepressants will be prescribed on individual basis. 2. Tailored physiotherapy targeting muscular dysfunction, utilizing: Patient education, pelvic floor muscle exercises (contraction and relaxation), EMG-biofeedback. Low frequent electrical stimulation, massage, stretching and myofascial release and trigger point treatment of the pelvic floor. Desensitization exercises (manually or vaginal dilator). Relaxation and body awareness. Minimum one visit per month. 3. Guided imagery sessions, minimum twice a week using a sound track that is developed for vulvodynia patients.

COMBINATION_PRODUCT

Treatment as usual

Treatment as usual in accordance with local guidelines by specialist in gynaecology, including a minimum of two visits (when diagnosis is made and after 3 - 6 months)

Locations (1)

Cecilie Hagemann

Trondheim, Norway