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Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

NCT ID: NCT01455350

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Vestibulodynia

Keywords

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provoked vestibulodynia multimodal physiotherapy lidocaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lidocaine

10 week treatment of daily application of topical lidocaine

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

10 weeks of daily topical 5% lidocaine application

Multimodal physiotherapy

10 weeks of weekly multimodal physiotherapy treatments

Group Type EXPERIMENTAL

Multimodal physiotherapy

Intervention Type PROCEDURE

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

Interventions

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Multimodal physiotherapy

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

Intervention Type PROCEDURE

lidocaine

10 weeks of daily topical 5% lidocaine application

Intervention Type DRUG

Other Intervention Names

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Xylocaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Mélanie Morin

Physiotherapist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melanie Morin, Pht, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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University of Montreal

Montreal, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 26600287 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type DERIVED
PMID: 32818475 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32434709 (View on PubMed)

Other Identifiers

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MOP-115028

Identifier Type: -

Identifier Source: org_study_id