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NCT02858375 Clinical Trial

Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia

Vestibulodynia Clinical Trial

— QUALVESTO  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02858375
Other study ID # P/2013/175
Secondary ID
Status Completed
Phase N/A
First received August 1, 2016
Last updated August 3, 2016
Start date March 2013
Est. completion date April 2013

Study information
Verified date August 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

The study aims to assess and compare the pain in women suffering from provoked vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18 months after treatment.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Vestibulodynia rated B2 according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification

- Patients previously treated no later than18 months ago for provoked vestibulodynia with botulinum toxin injections, in the University Hospital of Besançon.

Exclusion Criteria:

- Major psychologic disorders.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Besançon Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term pain improvement after botulinum toxin injections Assessment and comparison of pain using Visual Analogic Scale values before treatment,3 months after treatment and 18 months after treatment. 18 months No
See also
  Status Clinical Trial Phase
Completed NCT05478746 - Effects of Flourish HEC on Localized Provoked Vulvodynia N/A
Completed NCT01455350 - Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia N/A
Completed NCT01304589 - Savella in Treatment for Provoked Vestibulodynia Phase 3
Completed NCT03844412 - Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments Phase 2
Completed NCT02858219 - A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia Phase 3
Completed NCT01582373 - Pilot Study to Assess the Efficacy of Cognitive-behavioral Couple Therapy for Provoked Vestibulodynia N/A
Completed NCT05342402 - Feasibility Study for Provoked Vestibulodynia N/A
Recruiting NCT05805696 - Treatment and Mapping of Impostor Phenomenon N/A
Completed NCT01935063 - Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia N/A
Completed NCT02204319 - Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief N/A
Completed NCT02362763 - The Use of Acupuncture for the Treatment of Vulvar Vestibulitis N/A
Withdrawn NCT01741948 - Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia N/A
Terminated NCT02854670 - A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia Phase 2/Phase 3
Recruiting NCT04613713 - Somatocognitive Therapy in Treatment of Provoked (Localized) Vestibulodynia - Randomized Clinical Trial (ProLoVe Study) N/A
Terminated NCT01295268 - Study of Emu Oil vs. Placebo for Vulvar Pain in Women. N/A
Terminated NCT03682601 - Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment Phase 2
Withdrawn NCT03390049 - Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia N/A
Completed NCT00496184 - Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis Phase 3
Completed NCT03431779 - Lipofilling as a Treatment for Vestibulodynia N/A