NCT01455350

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

4.1 years

First QC Date

October 13, 2011

Last Update Submit

November 3, 2016

Conditions

Vestibulodynia

Keywords

provoked vestibulodyniamultimodal physiotherapylidocaine

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (6)

  • Change in pain catastrophizing

    before treatment, after treatment, 6 months after treatment

  • Change in psychologic distress

    before treatment, after treatment, 6 months after treatment

  • Change in fear of pain

    before treatment, after treatment, 6 months after treatment

  • Change in vulvar blood circulation

    before treatment, after treatment, 6 months after treatment

  • Change in pelvic floor muscles function

    before treatment, after treatment, 6 months after treatment

  • +1 more secondary outcomes

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

10 week treatment of daily application of topical lidocaine

Drug: lidocaine

Multimodal physiotherapy

EXPERIMENTAL

10 weeks of weekly multimodal physiotherapy treatments

Procedure: Multimodal physiotherapy

Interventions

Multimodal physiotherapyPROCEDURE

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

Multimodal physiotherapy
lidocaineDRUG

10 weeks of daily topical 5% lidocaine application

Also known as: Xylocaine
Lidocaine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Montreal

Montreal, Quebec, H3C 3T5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (4)

  • 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.

    PMID: 26600287BACKGROUND

  • 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.

    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.

    PMID: 32818475DERIVED

  • 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.

    PMID: 32434709DERIVED

MeSH Terms

Conditions

Vulvodynia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Melanie Morin, Pht, Ph.D.

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 19, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

CA(2)