PATIENTS WITH CHRONIC PELVIC PERINEAL PAIN OF UTERINE ORIGIN WITH VAS>4 MedDRA version: 20.0 Level: LLT Classification code 10048581 Term: Pelvic pain female System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 21.1 Level: LLT Classification code 10064189 Term: Chronic pelvic pain syndrome System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 21.1 Level: PT Classification code 10078087 Term: Genito-pelvic pain/penetration di
Conditions
Interventions
Trade Name: XEOMIN 200
Product Name: Toxine botulinique
Pharmaceutical Form: Powder for solution for injection
Sponsors
Centre de Recherche en Santé de la Femme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Be of age, - Present chronic pain of uterine origin VAS > 4 for at least 6 months, - These chronic pains of uterine origin can be due to severe dysmenorrhoea and/or deep dyspareunia and/or polycystic ovarian syndrome and/or fibroma and/or adenomyosis and/or superficial endometriosis, i.e. without involvement of organs other than gynaecological (e.g.: bladder, bowel, ureteral or more distant involvement) - To have been treated for these pains for at least 3 months, including at least a hormonal treatment and/or an analgesic treatment, or to have tried this treatment for at least 3 months, or to refuse this treatment, or intolerance, or contra-indication, - Be physically able to withstand a general anesthesia - To comply with the pre-anesthesia consultation before the operation - Have sufficient cooperation and understanding to comply with the requirements of the study, - Agree to give written consent, - Be affiliated with the French Social Security system. 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Be a minor, - Have a contraindication to botulinum toxin: myasthenia, anticoagulant and antiplatelet agents, coagulation disorders, treatment with an aminoglycoside, - Hypersensitivity to the active substance or to human albumin or sucrose, - Have a contraindication to general anesthesia - Not to have attended the pre-anesthesia consultation - Pelvic ultrasound and/or laparoscopy and/or pelvic MRI showing deep endometriosis-type abnormalities except adenomyosis, - Have generalized muscle activity disorders (e.g. myasthenia gravis, Lambert-Eaton syndrome), - Have an infection or inflammation of the uterine wall, - Have active cervical cancer or any other history of malignancy within 5 years prior to inclusion, with the exception of non-melanoma skin cancer treated without evidence of recurrence. - Be pregnant or breastfeeding, - Participating in another clinical trial, or being in the exclusion period, - Have a level of cooperation and understanding that does not allow strict compliance with the conditions of the protocol, - To benefit from a legal protection measure (curatorship, guardianship...), - Not be affiliated to the French Social Security system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the effectiveness of TB, measured through improvement in quality of life assessed by the Patient Global Impression of Improvement (PGI-I) symptom score;Secondary Objective: To have a complete assessment of the quality of life, the result of the treatment will also be evaluated by different self-questionnaires: - The EQ-5D-3L evaluating the state of health in a general and generic way - Leeds questionnaire to evaluate quality of sleep - The FSFI evaluating female sexual function - The digital scale of deep dyspareunia and dysmenorrhea, - Assessment of pain by the patient using a visual analogue scale - The study of side effects / drug tolerance / surgical complications - Assessment of the patient's overall satisfaction All data will be compared between the treatment group (uterine TB injections under hysteroscopy) and the control group;Primary end point(s): Questionnaire Patient Global Impression of Improvement (PGI-I);Timepoint(s) of evaluation of this end point: Questionnaires will be answered at inclusion before injection, then, 2, 6 and 16 weeks after injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall Quality of Life Score: EQ-5D-3L - Specific quality of life score: EHP-30 - Leeds questionnaire on sleeping quality - Score of female sexual function: FSFI - Annoyance score: Numerical scale (EN) for deep dyspareunia and dysmenorrhea - Assessment of pain by the patient using a Visual Analog Scale (VAS) - Side effects / drug tolerance / Surgical complications - Assessment of the patient's overall satisfaction - Medico-economic questionnaire;Timepoint(s) of evaluation of this end point: Questionnaires will be answered at inclusion before injection, then, 2, 6 and 16 weeks after injection | — |
Countries
France
Contacts
Public ContactNathalie MANON
MyCRO
Outcome results
None listed