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Multidisciplinary Treatment of Chronic Vulvar Pain

NCT03640624 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

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)

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Berit Schei, prof · Norwegian University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2024-11-10
Completion
2027-06-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640624 on ClinicalTrials.gov