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

NCT02773641 | Completed Phase 3

• 1 other identifier: BotA -KKDS2016, version 3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Women with provoked vestibulodynia (PVD) suffer from severe dyspareunia 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.

Conditions

Vulvodynia

Outcome Measures

Primary Outcomes (1)

• Self-reported dyspareunia measured by VAS

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

  Baseline to 6 months after baseline

Secondary Outcomes (5)

• Pain at tampon insertion measured by VAS 0-100

  Baseline to 6 months after baseline

• Reduction of pelvic floor hyperactivity/tonus,

  Baseline to 6 months after baseline

• Quality of Life (questionnaires)

  Baseline to 6 months after baseline

• Psychosexual evaluations (questionnaires)

  Baseline to 6 months after baseline

• Registrations of adverse events

  1 year

Study Arms (2)

Botulinum Toxin Type A

ACTIVE COMPARATOR

50 Allergan units (0.5 ml) injected in m bulbocavernosus twice with 3 months in between treatments

Drug: Botulinum Toxin Type A

Sterile saline solution

PLACEBO COMPARATOR

0.5 ml of sterile saline injected in m bulbocavernosus twice with 3 months in between treatments

Drug: Sterile Saline Solution

Interventions

Botulinum Toxin Type A DRUG

Also known as: Botox

Botulinum Toxin Type A

Sterile Saline Solution DRUG

Also known as: Sterile saline

Sterile saline solution

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• 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®) 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Danderyd Hospital, Dep. of Obstetrics and Gynecology

Stockholm, 182 88, Sweden

Location

Related Publications (2)

• Haraldson P, Muhlrad H, Heddini U, Nilsson K, Bohm-Starke N. Botulinum Toxin A for Provoked Vestibulodynia: 12 Months' Follow-up of a Randomized Controlled Trial. J Sex Med. 2022 Nov;19(11):1670-1679. doi: 10.1016/j.jsxm.2022.08.188. Epub 2022 Oct 26.

  PMID: 36307361 DERIVED

• Haraldson P, Muhlrad H, Heddini U, Nilsson K, Bohm-Starke N. Botulinum Toxin A as a Treatment for Provoked Vestibulodynia: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):524-532. doi: 10.1097/AOG.0000000000004008.

  PMID: 32769643 DERIVED

MeSH Terms

Conditions

Vulvodynia

Interventions

Botulinum Toxins, Type A

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

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: Associate professor

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 16, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)