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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | 10 week treatment of daily application of topical lidocaine |
|
| Multimodal physiotherapy | Experimental | 10 weeks of weekly multimodal physiotherapy treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal physiotherapy | Procedure | 10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain during intercourse | evaluated with a visual analog scale | before treatment, after treatment, 6 months after treatment |
| Change in global sexual function | evaluated with the female sexual function index (FSFI) | before treatment, after treatment, 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain catastrophizing | evaluated using the pain catastrophizing scale | before treatment, after treatment, 6 months after treatment |
| Change in psychologic distress | evaluated using the State-trait Anxiety Inventory (STAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Morin, Pht, Ph.D. | Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Montreal | Montreal | Quebec | H3C 3T5 | Canada | ||
| Centre Hospitalier Universitaire de Sherbrooke |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26600287 | Background | 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. | |
| Result | 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. | ||
| 32818475 |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| lidocaine | Drug | 10 weeks of daily topical 5% lidocaine application |
|
|
| before treatment, after treatment, 6 months after treatment |
| Change in fear of pain | evaluated using the Pain Anxiety Symptoms Scale (PASS-20) | before treatment, after treatment, 6 months after treatment |
| Change in vulvar blood circulation | evaluated using a doppler laser | before treatment, after treatment, 6 months after treatment |
| Change in pelvic floor muscles function | evaluated using transperineal ultrasound and dynamometry | before treatment, after treatment, 6 months after treatment |
| Change in pain sensitivity (pressure pain) | evaluated using a vulvagesiometer | before treatment, after treatment, 6 months after treatment |
| Sherbrooke |
| Quebec |
| J1H 5N4 |
| Canada |
| Derived |
| 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. |
| 32434709 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Aniline Compounds |
| D000588 | Amines |