Clinical trial NCT01455350: Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia
Official title: Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibulodynia
Keywords: provoked vestibulodynia
multimodal physiotherapy
lidocaine
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Fonds de la Recherche en Santé du Québec
First posted: 2011-10-19
Enrollment: 212
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain during intercourse
timeFrame: before treatment, after treatment, 6 months after treatment
measure: Change in global sexual function
timeFrame: before treatment, after treatment, 6 months after treatment
Secondary outcomes:
measure: Change in pain catastrophizing
timeFrame: before treatment, after treatment, 6 months after treatment
measure: Change in psychologic distress
timeFrame: before treatment, after treatment, 6 months after treatment
measure: Change in fear of pain
timeFrame: before treatment, after treatment, 6 months after treatment
measure: Change in vulvar blood circulation
timeFrame: before treatment, after treatment, 6 months after treatment
measure: Change in pelvic floor muscles function
timeFrame: before treatment, after treatment, 6 months after treatment
measure: Change in pain sensitivity (pressure pain)
timeFrame: before treatment, after treatment, 6 months after treatment
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: University of Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Melanie Morin, Pht, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morin M, Dumoulin C, Bergeron S, Mayrand MH, Khalife 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;46:52-59. doi: 10.1016/j.cct.2015.11.013. Epub 2015 Nov 18.
citation: 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 vestibulodynia. 40th Annual Meeting of the International Urogynecological Association, Nice, France, 2015, Int Urogynecol J, 1(Supp - June 2015), PP22.
citation: Morin M, Dumoulin C, Bergeron S, Mayrand MH, Khalife S, Waddell G, Dubois MF; PVD Study Group. Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial. Am J Obstet Gynecol. 2021 Feb;224(2):189.e1-189.e12. doi: 10.1016/j.ajog.2020.08.038. Epub 2020 Aug 18.
citation: Benoit-Piau J, Dumoulin C, Carroll MS, Mayrand MH, Bergeron S, Khalife S, Waddell G, Morin M; Provoked Vestibulodynia (PVD) Study Group. Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. J Sex Med. 2020 Jul;17(7):1304-1311. doi: 10.1016/j.jsxm.2020.04.005. Epub 2020 May 17.