Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02773641
• Date of registration: 04/05/2016
• Prospective Registration: No
• Primary sponsor: Karolinska Institutet
• Public title: Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia
• Scientific title: Double Blind Placebo-controlled RCT of the Efficacy and Safety of Intramuscular Injections of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia
• Date of first enrolment: May 2016
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02773641
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Sweden

Contacts

• Name: Nina Bohm-Starke, MD
• Affiliation: Karolinska Institutet

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18-40 years

- PVD defined as significant pain at vestibular contact and vaginal entry (VAS = 6 at
the tampon test or severe pain, preventing intercourse)

- Duration of symptoms of = 3 months,

- 0-para,

- Patients who are willing to participate in the study after it has been explained
orally and in writing will be included.

Exclusion Criteria:

- Vulvo-vaginal infection, dermatological conditions or other causes to dyspareunia

- Regular medication with analgesics

- Major psychiatric or medical disease

- Known allergy to any components of the active drug (Botox®) or medical disease
contradictory to treatment with the active drug (Botox®) (peripheral motor
neurological disease such as myasthenia gravis, amyotrophic lateral sclerosis or
Lambert-Eaton syndrome and diabetes),

- Pregnancy - a pregnancy test will be taken before both treatments (Visit 1 and 3),
unless the participants are using highly effective birth control methods that can
achieve a failure rate of less than 1% per year, when used consistently and correctly.
Such methods include;

- combined (estrogen and progestogen containing) hormonal contraception associated with
inhibition of ovulation (oral, intravaginal, transdermal)

- progestogen-only hormonal contraception associated with inhibition of ovulation (oral,
injectable, implantable)

- intrauterine device (IUD)

- intrauterine hormone-releasing system (IUS)

- bilateral tubal occlusion

- sexual abstinence (if refraining from heterosexual intercourse during the entire
period of risk associated with the study treatments. The reliability of sexual
abstinence needs to be evaluated in relation to the preferred and usual lifestyle of
the subject.

- Pelvic floor deficiency with urine and or flatulence incontinence.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Vulvodynia

Intervention(s)

Drug: Sterile Saline Solution

Drug: Botulinum Toxin Type A

Primary Outcome(s)

Self-reported dyspareunia measured by VAS [Time Frame: Baseline to 6 months after baseline]

Secondary Outcome(s)

Quality of Life (questionnaires) [Time Frame: Baseline to 6 months after baseline]

Reduction of pelvic floor hyperactivity/tonus, [Time Frame: Baseline to 6 months after baseline]

Psychosexual evaluations (questionnaires) [Time Frame: Baseline to 6 months after baseline]

Registrations of adverse events [Time Frame: 1 year]

Pain at tampon insertion measured by VAS 0-100 [Time Frame: Baseline to 6 months after baseline]

Secondary ID(s)

BotA -KKDS2016, version 3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors