A clinical trial for Botox as 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 - BotA-KKDS2016

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000375-25-SE

Enrollment

Registered

2016-02-29

Start date

2016-04-19

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Provoked vestibulodynia

Interventions

Trade Name: Botox (botulinum toxin A) Pharmaceutical Form: Concentrate and solvent for solution for injection Pharmaceutical form of the placebo: Solution for injection/infusion Route of administratio

Eligibility

Sex/Gender

All

Inclusion 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 • Nullipara. • Patients who are willing to participate in the study after it has been explained orally and in writing will be included. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Local infection, dermatological conditions or other causes to dyspareunia, • Major psychiatric or medical disease (peripheral motor neurological disease such as myasthenia gravis, amyotrophic lateral sclerosis or Lambert-Eaton syndrome and diabetes) • Pregnancy • Pelvic floor deficiency with urine and or flatulence incontinence.

Design outcomes

Primary

Measure	Time frame
Main Objective: The reduction of patient self-reported dyspareunia and/or pain at tampon insertion as measured by Visual Analogue Scale 0 (no pain) to 100 (worst pain imaginable) ;Secondary Objective: 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.;Primary end point(s): Pain score in millimetres from "no pain" will be analysed as a continuous variable and compared between groups.;Timepoint(s) of evaluation of this end point: The patients will be asked to indicate with an X on a 100 mm long line marked with "no pain" to the left hand side and "worst imaginable pain" at the right hand side (Visual Analogue Scale- VAS) how much pain has during vaginal intercourse and/or tampon insertion. The first evaluation is before randomisation and treatment (baseline) and related to experienced pain the last month. The patients will then regularly report weekly in a diary the pain during vaginal intercourse and/or tampon insertion and also report at the follow ups, see below.	—

Measure

Time frame

Main Objective: The reduction of patient self-reported dyspareunia and/or pain at tampon insertion as measured by Visual Analogue Scale 0 (no pain) to 100 (worst pain imaginable) ;Secondary Objective: 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.;Primary end point(s): Pain score in millimetres from "no pain" will be analysed as a continuous variable and compared between groups.;Timepoint(s) of evaluation of this end point: The patients will be asked to indicate with an X on a 100 mm long line marked with "no pain" to the left hand side and "worst imaginable pain" at the right hand side (Visual Analogue Scale- VAS) how much pain has during vaginal intercourse and/or tampon insertion. The first evaluation is before randomisation and treatment (baseline) and related to experienced pain the last month. The patients will then regularly report weekly in a diary the pain during vaginal intercourse and/or tampon insertion and also report at the follow ups, see below.

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Secondary

Measure	Time frame
Secondary end point(s): Serious adverse events will immediately be reported to the research nurse and responsible gynaecologists (investigators). Any minor adverse events will be reported in the weekly diary and checked for at all follow ups. The hyperactivity of the pelvic floor muscles will be analysed by vaginal pressure measurements using a plastic catheter (4 mm) with a pressure transducer at the top. Resting tonus, maximum contraction strength and 10 s endurance of contraction will be measured in cm H2O. Questionnaires on general health and reproductive health will be filled out at baseline. Questionnaires on sexual dysfunction and distress and quality of life will be filled out. • Female Sexual Function Index (FSFI) • Female Sexual Distress Scale (FSDS) • Quality of life (WHOQOL-BRIEF, Swedish version and EQ-5D) • PSS (perceived stress scale), • Anxiety questionnaire (Spence, Swedish version). ;Timepoint(s) of evaluation of this end point: Serious adverse events will immediately be reported to the research nurse and responsible gynaecologists (investigators). Any minor adverse events will be reported in the weekly diary and checked for at all follow ups. The vaginal pressure will be measured before treatment and at all follow-ups; Visit 2, 4-6 weeks after baseline Visit 3, 12 weeks after baseline Visit 4, 16-18 weeks after baseline Visit 5, 6 months after baseline Visit 6, final study visit, 12 months from baseline. The questionnaires will be filled out at baseline. visit 3 , 5 and 6. •	—

Measure

Time frame

Secondary end point(s): Serious adverse events will immediately be reported to the research nurse and responsible gynaecologists (investigators). Any minor adverse events will be reported in the weekly diary and checked for at all follow ups. The hyperactivity of the pelvic floor muscles will be analysed by vaginal pressure measurements using a plastic catheter (4 mm) with a pressure transducer at the top. Resting tonus, maximum contraction strength and 10 s endurance of contraction will be measured in cm H2O. Questionnaires on general health and reproductive health will be filled out at baseline. Questionnaires on sexual dysfunction and distress and quality of life will be filled out. • Female Sexual Function Index (FSFI) • Female Sexual Distress Scale (FSDS) • Quality of life (WHOQOL-BRIEF, Swedish version and EQ-5D) • PSS (perceived stress scale), • Anxiety questionnaire (Spence, Swedish version). ;Timepoint(s) of evaluation of this end point: Serious adverse events will immediately be reported to the research nurse and responsible gynaecologists (investigators). Any minor adverse events will be reported in the weekly diary and checked for at all follow ups. The vaginal pressure will be measured before treatment and at all follow-ups; Visit 2, 4-6 weeks after baseline Visit 3, 12 weeks after baseline Visit 4, 16-18 weeks after baseline Visit 5, 6 months after baseline Visit 6, final study visit, 12 months from baseline. The questionnaires will be filled out at baseline. visit 3 , 5 and 6. •

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Countries

Sweden

Contacts

Public ContactDept of Obstetrics and Gynecology

Danderyds sjukhus AB

nina.bohm-starke@s.se46812355000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026