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Completed

NCT Number: NCT01455350

Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

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).

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Montreal, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal physiotherapy

Procedure

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

Lidocaine

Drug

10 weeks of daily topical 5% lidocaine application

Other names: Xylocaine

Primary outcomes

  1. Change in pain during intercourse

    Time frame: before treatment, after treatment, 6 months after treatment

    evaluated with a visual analog scale

  2. Change in global sexual function

    Time frame: before treatment, after treatment, 6 months after treatment

    evaluated with the female sexual function index (FSFI)

Secondary outcomes

  1. Change in pain catastrophizing

    Time frame: before treatment, after treatment, 6 months after treatment

    evaluated using the pain catastrophizing scale

  2. Change in psychologic distress

    Time frame: before treatment, after treatment, 6 months after treatment

    evaluated using the State-trait Anxiety Inventory (STAI)

  3. Change in fear of pain

    Time frame: before treatment, after treatment, 6 months after treatment

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

  4. Change in vulvar blood circulation

    Time frame: before treatment, after treatment, 6 months after treatment

    evaluated using a doppler laser

  5. Change in pelvic floor muscles function

    Time frame: before treatment, after treatment, 6 months after treatment

    evaluated using transperineal ultrasound and dynamometry

  6. Change in pain sensitivity (pressure pain)

    Time frame: before treatment, after treatment, 6 months after treatment

    evaluated using a vulvagesiometer

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 19, 2011
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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