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Trial record 3 of 3 for:    "Vulvar Vestibulitis Syndrome" | "Acetylcholine Release Inhibitors"

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

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ClinicalTrials.gov Identifier: NCT02773641
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Nina Bohm-Starke, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Vulvodynia Drug: Botulinum Toxin Type A Drug: Sterile Saline Solution Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Placebo-controlled RCT of the Efficacy and Safety of Intramuscular Injections of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia
Actual Study Start Date : May 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Active Comparator: Botulinum Toxin Type A
50 Allergan units (0.5 ml) injected in m bulbocavernosus twice with 3 months in between treatments
Drug: Botulinum Toxin Type A
Other Name: Botox

Placebo Comparator: Sterile saline solution
0.5 ml of sterile saline injected in m bulbocavernosus twice with 3 months in between treatments
Drug: Sterile Saline Solution
Other Name: Sterile saline




Primary Outcome Measures :
  1. The reduction of patient self-reported dyspareunia measured by VAS [ Time Frame: Baseline to 6 months after baseline ]
    VAS 0 (no pain) to 100 (worst pain imaginable)


Secondary Outcome Measures :
  1. Pain at tampon insertion measured by VAS 0-100 [ Time Frame: Baseline to 6 months after baseline ]
    VAS 0 (no pain) to 100 (worst pain imaginable)

  2. Reduction of pelvic floor hyperactivity/tonus, [ Time Frame: Baseline to 6 months after baseline ]
    Measured with a vaginal manometer

  3. Quality of life [ Time Frame: Baseline to 6 months after baseline ]
    Use of validated questionnaires

  4. Psychosexual evaluations (questionnaires) [ Time Frame: Baseline to 6 months after baseline ]
    Use of validated questionnaires

  5. Registrations of adverse events [ Time Frame: 1 year ]
    Adverse events will be registered according to the protocool



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773641


Contacts
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Contact: Helen Fagraeus, Midwife +46 8 123 550 00 helen.fagraeus@sll.se
Contact: Annelie Sjölund, Midwife +46 8 123 550 00 annelie.sjolund@sll.se

Locations
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Sweden
Danderyd Hospital, Dep. of Obstetrics and Gynecology Recruiting
Stockholm, Sweden, 182 88
Contact: Helen Fagraeus, Midwife    +46 8 123 550 00    helen.fagraeus@sll.se   
Contact: Annelie Sjölund, Midwife    +46 8 123 550 00    annelie.sjolund@sll.se   
Principal Investigator: Nina Bohm-Starke, MD, PhD         
Sub-Investigator: Ulrika Heddini, MD, PhD         
Sub-Investigator: Philip Haraldson, MD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Nina Bohm-Starke, MD Karolinska Institutet

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Responsible Party: Nina Bohm-Starke, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02773641     History of Changes
Other Study ID Numbers: BotA -KKDS2016, version 3
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Vulvar Vestibulitis
Acetylcholine Release Inhibitors
Vulvodynia
Vulvar Diseases
Genital Diseases, Female
Vulvitis
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents