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A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia (VESTIBULE)

Primary Purpose

Vestibulodynia

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Botulinum Toxin Type A

Saline solution

Indexes

About this trial

This is an interventional treatment trial for Vestibulodynia focused on measuring Botulinum toxin, Pain improvement

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
Negative screening test results
Notified associated factors
Menopause, surgically sterilized women or women using effective contraceptive method
Good understanding and predictable adherence to the protocol
beneficiary/affiliated to French social security/social healthcare
signed Informed Consent Form

Exclusion Criteria:

Predictable poor adherence
Pregnant or breastfeeding women
Myasthenia
Treatment with aminoglycosides
Major mental disorders
Underlying etiology
Vulnerable subjects (particularly adults under guardianship)
Any reason deemed relevant by the investigator
Current or former (in the last 3 months) participation to another clinical trial

Sites / Locations

CHU Besançon
Hôpital Tenon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum toxin

Saline solution

Arm Description

Injection of 50 units (50U) botulinum toxin type A (powder), reconstituted in 1 mL physiologic saline solution in each perineal muscle (100 units in total). First injection at day 1 and. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).

Injection of 1 mL physiologic saline solution in each perineal muscle. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).

Outcomes

Primary Outcome Measures

Pain improvement

Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale

Secondary Outcome Measures

Full Information

NCT ID

NCT02858219

First Posted

August 1, 2016

Last Updated

November 9, 2022

Sponsor

Centre Hospitalier Universitaire de Besancon

1. Study Identification

Unique Protocol Identification Number

NCT02858219

Brief Title

A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia

Acronym

VESTIBULE

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

May 4, 2010 (Actual)

Primary Completion Date

February 11, 2019 (Actual)

Study Completion Date

February 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.

6. Conditions and Keywords

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

Vestibulodynia

Keywords

Botulinum toxin, Pain improvement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botulinum toxin

Arm Type

Experimental

Arm Description

Arm Title

Saline solution

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin Type A

Intervention Type

Other

Intervention Name(s)

Saline solution

Intervention Type

Other

Intervention Name(s)

Indexes

Intervention Description

Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)

Primary Outcome Measure Information:

Title

Pain improvement

Description

Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy) Negative screening test results Notified associated factors Menopause, surgically sterilized women or women using effective contraceptive method Good understanding and predictable adherence to the protocol beneficiary/affiliated to French social security/social healthcare signed Informed Consent Form Exclusion Criteria: Predictable poor adherence Pregnant or breastfeeding women Myasthenia Treatment with aminoglycosides Major mental disorders Underlying etiology Vulnerable subjects (particularly adults under guardianship) Any reason deemed relevant by the investigator Current or former (in the last 3 months) participation to another clinical trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fabien Pelletier, MD

Organizational Affiliation

Centre Hospitalier Universitaire de Besancon

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Besançon

City

Besançon

ZIP/Postal Code

25000

Country

France

Facility Name

Hôpital Tenon

City

Paris

ZIP/Postal Code

75020

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia

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