Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

Vestibulodynia Clinical Trial

Official title:

Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455350
• Other study ID #: MOP-115028
• Status: Completed
• Phase: N/A
• First received: October 13, 2011
• Last updated: November 3, 2016
• Start date: October 2011
• Est. completion date: November 2015

Study information

• Verified date: November 2016
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Chronic gynaecological pain is a major medical problem that affects 20-30% of women at different moments of their life. This largely neglected issue has a significant impact on the sexual and conjugal life of women suffering from it as well as on their psychological health. Furthermore, this kind of pain is not well understood, often misdiagnosed or even totally ignored. Also, treatment is limited and not extensively studied. This study aims at better understanding and treating gynaecological pain. The focus of the study will be provoked vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva. The treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering from provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital, Royal-Victoria Hospital, CHUM St-Luc).

Description:

This is a randomised controlled trial comparing the impact of multimodal physiotherapy treatments to topical lidocaine in women suffering from provoked vestibulodyina. The first treatment consists of 10 sixty minutes weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises. The second treatment is a night time application of lidocaine to the vulva for 10 weeks. Physiotherapists will then evaluate women's pain and sexual function right after the treatment and 6 months later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Moderate to severe pain in at least 90% of sexual intercourses.

• Moderate to severe pain during the cotton-swab test at one of more vestibule regions (5/10 minimum pain evaluation on the verbal pain intensity scale).

• Pain limited to the vestibule during vaginal penetrations and during activities applying pressure on the vestibule.

• Provoked vestibulodynia lasting at least 6 months prior to the study and diagnosed by a standardised gynaecologic exam protocol by one of our collaborator.

Exclusion Criteria:

• Major psychiatric condition or pelvic pathology associated with a genital pain problem (e.g.: dyspareunia).

• Use of medication that could influence pain perception.

• Actual or past pregnancy.

• Vulvar or vaginal surgery

• Post-menopausal state

• Unwillingness to restrain from other treatments till the 6 months post-treatment evaluation.

• Urogynaecologic symptoms (urinary/anal incontinence, pelvic organs prolapsus, urinary/vaginal infection active or during the last 3 months).

• Incapacity to have sexual intercourse including vaginal penetration during the last 6 months.

• Physiotherapy treatments or lidocaine application prior to the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Procedure:
• Multimodal physiotherapy
10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.

Drug:
• lidocaine
10 weeks of daily topical 5% lidocaine application

Locations

Country	Name	City	State
Canada	University of Montreal	Montreal	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

References & Publications (2)

M. Morin, C. Dumoulin, S. Bergeron, M.H. Mayrand, S. Khalifé, G. Waddell, O. Dubois, M.F. Dubois, PVD Study Group. Randomized controlled trial of multimodal physiotherapy treatment compared to overnight topical lidocaine in women suffering from provoked v

Morin M, Dumoulin C, Bergeron S, Mayrand MH, Khalifé S, Waddell G, Dubois MF; Provoked vestibulodynia (PVD) Study Group.. Randomized clinical trial of multimodal physiotherapy treatment compared to overnight lidocaine ointment in women with provoked vestibulodynia: Design and methods. Contemp Clin Trials. 2016 Jan;46:52-9. doi: 10.1016/j.cct.2015.11.013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain during intercourse	evaluated with a visual analog scale	before treatment, after treatment, 6 months after treatment	No
Primary	Change in global sexual function	evaluated with the female sexual function index (FSFI)	before treatment, after treatment, 6 months after treatment	No
Secondary	Change in pain catastrophizing	evaluated using the pain catastrophizing scale	before treatment, after treatment, 6 months after treatment	No
Secondary	Change in psychologic distress	evaluated using the State-trait Anxiety Inventory (STAI)	before treatment, after treatment, 6 months after treatment	No
Secondary	Change in fear of pain	evaluated using the Pain Anxiety Symptoms Scale (PASS-20)	before treatment, after treatment, 6 months after treatment	No
Secondary	Change in vulvar blood circulation	evaluated using a doppler laser	before treatment, after treatment, 6 months after treatment	No
Secondary	Change in pelvic floor muscles function	evaluated using transperineal ultrasound and dynamometry	before treatment, after treatment, 6 months after treatment	No
Secondary	Change in pain sensitivity (pressure pain)	evaluated using a vulvagesiometer	before treatment, after treatment, 6 months after treatment	No