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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Unknown status

CT.gov ID

NCT02858219

Collaborator

(none)

Enrollment

Locations

Arms

108

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibulodynia	Drug: Botulinum Toxin Type A Other: Saline solution Other: Indexes	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Actual Study Start Date :

May 4, 2010

Anticipated Primary Completion Date :

May 4, 2019

Anticipated Study Completion Date :

May 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum toxin 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).	Drug: Botulinum Toxin Type A Other: Indexes Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)
Placebo Comparator: Saline solution 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).	Other: Saline solution Other: Indexes Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)

Arm

Intervention/Treatment

Experimental: Botulinum toxin

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).

Drug: Botulinum Toxin Type A

Other: Indexes

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

Placebo Comparator: Saline solution

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).

Other: Saline solution

Other: Indexes

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

Outcome Measures

Primary Outcome Measures

Pain improvement [3 months]
Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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