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

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

Vulvodynia

Botulinum Toxin Type A

Sterile Saline Solution

Danderyd Hospital, Dep. of Obstetrics and Gynecology

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

Double Blind Placebo-controlled RCT of the Efficacy and Safety of Intramuscular Injections of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia

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

Adverse events will be registered according to the protocool

Nina Bohm-Starke

Associate professor

Karolinska Institutet

Peripheral blood cells will be extracted from all blood samples. mRNA will be purified from all samples. The mRNA will be divided to aliquots and will be frozen in -80°C until further processing after all cohort samples have been collected. mRNAs will be purified from whole blood using the QIAamp RNA purification kit (Quiagen Germany). A DNase I (Qiagen) digestion step is included in order to eliminate genomic DNA. Serum will be collected from all blood samples. It will will be frozen in -70°C until further processing after all cohort samples have been collected.

Vestibulodynia

The study will follow patients who are first time users of HCs for a full year after initiation. Patients will be followed every 3 months via questionnaires, blood examinations, and gynecologic examination, in case dyspareunia evolves.
First appointment (before initiation of HCs):
Questionnaire FSFI (Female Sexual Function Index) questionnaire. Blood collection for hormones levels and extraction of mononuclear blood cells. A gynecologic exam intended to rule out existing problem which causing dyspareunia.
3,6,9,and 12 months after initiation of HCs or anytime if a patient has dyspareunia:
Questionnaire evaluating possible influence of HCs use (dyspareunia, lubrication and libido).
FSFI questionnaire. Blood collection Gynecologic examination, designated to assess the cause of pain, including assessment of vestibular tenderness, muscle tightness and tenderness, pressure-pain thresholds measurement using vulvar algesiometer, pH measurement and vaginal swab for microscopy.

Hormonal contraceptive

Clalit health Services

Hadassah Medical Organization

Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia

Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia- A Prospective Study

one year for patients' enrollment and another year for follow up.

Dose of ethinyl estradiol (15, 20 and 30 mcg) The progesterone component

Age at menarche Length of use Body mass index

Hormones: E2, testosterone Altered gene expression

vulvodynia/progesterone

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

Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia

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