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Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

Primary Purpose

Vestibulodynia

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Multimodal physiotherapy

lidocaine

About this trial

This is an interventional treatment trial for Vestibulodynia focused on measuring provoked vestibulodynia, multimodal physiotherapy, lidocaine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Montreal
Centre Hospitalier Universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lidocaine

Multimodal physiotherapy

Arm Description

10 week treatment of daily application of topical lidocaine

10 weeks of weekly multimodal physiotherapy treatments

Outcomes

Primary Outcome Measures

Change in pain during intercourse

evaluated with a visual analog scale

Change in global sexual function

evaluated with the female sexual function index (FSFI)

Secondary Outcome Measures

Change in pain catastrophizing

evaluated using the pain catastrophizing scale

Change in psychologic distress

evaluated using the State-trait Anxiety Inventory (STAI)

Change in fear of pain

evaluated using the Pain Anxiety Symptoms Scale (PASS-20)

Change in vulvar blood circulation

evaluated using a doppler laser

Change in pelvic floor muscles function

evaluated using transperineal ultrasound and dynamometry

Change in pain sensitivity (pressure pain)

evaluated using a vulvagesiometer

Full Information

NCT ID

NCT01455350

First Posted

October 13, 2011

Last Updated

November 3, 2016

Sponsor

Université de Sherbrooke

Collaborators

Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

1. Study Identification

Unique Protocol Identification Number

NCT01455350

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Université de Sherbrooke

Collaborators

Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vestibulodynia

Keywords

provoked vestibulodynia, multimodal physiotherapy, lidocaine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

212 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Active Comparator

Arm Description

10 week treatment of daily application of topical lidocaine

Arm Title

Multimodal physiotherapy

Arm Type

Experimental

Arm Description

10 weeks of weekly multimodal physiotherapy treatments

Intervention Type

Procedure

Intervention Name(s)

Multimodal physiotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

lidocaine

Other Intervention Name(s)

Xylocaine

Intervention Description

10 weeks of daily topical 5% lidocaine application

Primary Outcome Measure Information:

Title

Change in pain during intercourse

Description

evaluated with a visual analog scale

Time Frame

before treatment, after treatment, 6 months after treatment

Title

Change in global sexual function

Description

evaluated with the female sexual function index (FSFI)

Time Frame

before treatment, after treatment, 6 months after treatment

Secondary Outcome Measure Information:

Title

Change in pain catastrophizing

Description

evaluated using the pain catastrophizing scale

Time Frame

before treatment, after treatment, 6 months after treatment

Title

Change in psychologic distress

Description

evaluated using the State-trait Anxiety Inventory (STAI)

Time Frame

before treatment, after treatment, 6 months after treatment

Title

Change in fear of pain

Description

evaluated using the Pain Anxiety Symptoms Scale (PASS-20)

Time Frame

before treatment, after treatment, 6 months after treatment

Title

Change in vulvar blood circulation

Description

evaluated using a doppler laser

Time Frame

before treatment, after treatment, 6 months after treatment

Title

Change in pelvic floor muscles function

Description

evaluated using transperineal ultrasound and dynamometry

Time Frame

before treatment, after treatment, 6 months after treatment

Title

Change in pain sensitivity (pressure pain)

Description

evaluated using a vulvagesiometer

Time Frame

before treatment, after treatment, 6 months after treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melanie Morin, Pht, Ph.D.

Organizational Affiliation

Université de Sherbrooke

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Montreal

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3C 3T5

Country

Canada

Facility Name

Centre Hospitalier Universitaire de Sherbrooke

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

26600287

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.

Results Reference

background

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.

Results Reference

result

PubMed Identifier

32818475

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.

Results Reference

derived

PubMed Identifier

32434709

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.

Results Reference

derived

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Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

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