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VestibulodyniaNCT01455350

Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

A study testing Multimodal physiotherapy and lidocaine in people with Vestibulodynia, run by Université de Sherbrooke at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Vestibulodynia
What is being tested?
Multimodal physiotherapy and lidocaine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
2 sitesCanada
Study dates
Oct 2011to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Montreal

    Montreal, Quebec, H3C 3T5

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine

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).

Read the 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.

Conditions
Vestibulodynia
Being tested
Multimodal physiotherapy, lidocaine
Keywords
provoked vestibulodynia, multimodal physiotherapy, lidocaine
Medical subject headings
Vulvodynia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal physiotherapyProcedure or surgery

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

  • lidocaineDrug

    Also called Xylocaine

    10 weeks of daily topical 5% lidocaine application

Study groups in NCT01455350
Study groupRoleWhat they receive
LidocaineActive comparator10 week treatment of daily application of topical lidocaine
Receives: Drug: lidocaine
Multimodal physiotherapyExperimental10 weeks of weekly multimodal physiotherapy treatments
Receives: Procedure: Multimodal physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain during intercourse

    evaluated with a visual analog scale

    Measured: before treatment, after treatment, 6 months after treatment

  2. Change in global sexual function

    evaluated with the female sexual function index (FSFI)

    Measured: before treatment, after treatment, 6 months after treatment

Secondary outcomes (6)

  1. Change in pain catastrophizing

    evaluated using the pain catastrophizing scale

    Measured: before treatment, after treatment, 6 months after treatment

  2. Change in psychologic distress

    evaluated using the State-trait Anxiety Inventory (STAI)

    Measured: before treatment, after treatment, 6 months after treatment

  3. Change in fear of pain

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

    Measured: before treatment, after treatment, 6 months after treatment

  4. Change in vulvar blood circulation

    evaluated using a doppler laser

    Measured: before treatment, after treatment, 6 months after treatment

  5. Change in pelvic floor muscles function

    evaluated using transperineal ultrasound and dynamometry

    Measured: before treatment, after treatment, 6 months after treatment

  6. Change in pain sensitivity (pressure pain)

    evaluated using a vulvagesiometer

    Measured: before treatment, after treatment, 6 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01455350
Sponsor's protocol ID
MOP-115028
Status last verified
Nov 2016
First submitted
13 Oct 2011
Last updated
4 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26600287

  • 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.

  • 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.

    PubMed 32818475

  • 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.

    PubMed 32434709

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal physiotherapy and lidocaine in people with Vestibulodynia, run by Université de Sherbrooke at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain during intercourse (time frame: before treatment, after treatment, 6 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01455350, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.

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