Botulinum Toxin A as a Treatment for Provoked Vestibulodynia

NCT04057755 | Completed Phase 3

• 1 other identifier: 2016-000375-25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Women with provoked vestibulodynia (PVD) suffer from severe dyspareuni and often present a hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The rationale for the study is that for women with PVD who don't succeed to restore the function of the PFM by physiotherapy, Botulinum Toxin A (BTA) could be an optional treatment by decreasing the high muscle tonus and thus possibly reduce the coital pain. Objectives and outcome Women with PVD will be recruited for a double blind RCT of 2 injection of 50 Allergan-units BTA (3 months apart) or placebo in the bulbocavernous muscles (situated adjacent to the lower part of the vagina). Primary outcome: The reduction of patient self-reported dyspareunia measured by VAS 0 (no pain) to 100 (worst pain imaginable). Secondary outcome: Pain at tampon insertion measured by VAS 0-100, functional measurement of dyspareunia (see below), the reduction of pelvic floor hyperactivity/tonus, measured with a vaginal manometer, safety aspects and effect duration of BTA, influence on quality of life and psychosexual evaluation.

Conditions

Vulvodynia

Keywords

botulinum toxin A; treatment

Outcome Measures

Primary Outcomes (1)

• Change in self-reported dyspareunia last month measured by VAS 0-100

  VAS 0 (no pain) to 100 (worst pain imaginable).

  At baseline up to 6 months

Secondary Outcomes (9)

• Change in pain at tampon insertion last week, measured by VAS 0-100

  At baseline and up to 12 months

• Change in pelvic floor hyperactivity/tonus,

  At baseline and up to 12 months

• Safety aspects regarding adverse events of BTA

  The complete study, 12 months

• Change in quality of Life (WHOQOL-BREF)

  At baseline and up to 12 months

• Change in quality of Life (EQ5D)

  At baseline and up to 12 months

Study Arms (3)

Botulinum toxin A vs placebo

EXPERIMENTAL

50 Allergan units (diluted in 0,5 ml sterile NaCl) or 0,5 ml of sterile NaCl will be injected in the bulbocavernosus muscle just inside the hymenal ring. The injection with the same substance, dose and volume will be repeated after 3 months.

Drug: botulinum toxin A; Drug: NaCl

Botulinum toxin A

ACTIVE COMPARATOR

50 Allergan units (diluted in 0,5 ml sterile NaCl) will be injected in the bulbocavernosus muscle just inside the hymenal ring. The injection with the same substance, dose and volume will be repeated after 3 months.

Drug: botulinum toxin A

NaCl

PLACEBO COMPARATOR

0,5 ml of sterile NaCl will be injected in the bulbocavernosus muscle just inside the hymenal ring. The injection with the same substance and volume will be repeated after 3 months.

Drug: NaCl

Interventions

botulinum toxin A DRUG

Also known as: Botox

Botulinum toxin A; Botulinum toxin A vs placebo

NaCl DRUG

Also known as: Saline

Botulinum toxin A vs placebo; NaCl

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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®)
• 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
• Diabetes)
• Pregnancy
• Pelvic floor deficiency with urine and or flatulence incontinence.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Danderyd Hospital, Dep. of Obstetrics and Gynecology

Stockholm, 182 88, Sweden

Location

MeSH Terms

Conditions

Vulvodynia

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Nina Bohm-Starke, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, associte professor

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: August 15, 2019
• Study Start: May 15, 2016
• Primary Completion: June 15, 2019
• Study Completion: June 15, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)