Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea

Официальное название

Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea: A Prospective, Multicenter, Double-Blind, Randomized Placebo-Controlled Study.

Обзор

The objective of the study is to evaluate the global impression of improvement at 3 months following intramyometrial botulinum toxin injections via hysteroscopy in women with severe primary dysmenorrhea who have failed first-line medical treatment, compared to intramyometrial placebo injections.

Подробное описание

This trial is multicenter, placebo-controlled, randomized with center-based stratification, double-blind and prospective. The treatment consists of a single injection follow by 6 months of follow-up.

Вмешательства

• Препарат Xeomin
  One injection will be performed via hysteroscopy under local anesthesia.
• Препарат Placebo
  One injection will be performed via hysteroscopy under local anesthesia.

Первичные конечные точки

• Patient Global Improvement [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Average intensity of dysmenorrhea [Срок оценки: 6 months]
• Maximum intensity of dysmenorrhea [Срок оценки: 6 months]
• Duration of dysmenorrhea [Срок оценки: 6 months]
• Average intensity of non-menstrual pelvic pain [Срок оценки: 6 months]
• Maximum intensity of non-menstrual pelvic pain [Срок оценки: 6 months]
• Duration of non-menstrual pelvic pain [Срок оценки: 6 months]
• Average intensity of pain during the most recent sexual intercourse [Срок оценки: 6 months]
• Sexual function assessed using the Female Sexual Function Index [Срок оценки: 6 months]
• Central sensitization to pain [Срок оценки: 3 months]
• Heavy menstrual bleeding assessed using the Higham score [Срок оценки: 6 months]
• General quality of life [Срок оценки: 6 months]
• Disease-specific quality of life [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Adult women who are not menopausal,
• Presenting with:
• Either severe primary dysmenorrhea, defined by an average pain intensity (VAS) ≥ 6/10 over the last 3 months at the inclusion visit,
• Or, in cases of amenorrhea under hormonal treatment, severe chronic pelvic pain (average VAS ≥ 6/10 over the last 3 months), described as cramp-like, localized in the pelvic region, and similar to the initial dysmenorrhea pain.
• Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Level I and II analgesics, and NSAIDs),
• Having undergone a pelvic MRI within 1 year prior to the randomization visit that shows no evidence of deep infiltrating endometriosis or endometrioma, following systematic review by radiologists from the expert center managing the patient (if the pelvic MRI is deemed of insufficient quality for interpretation, a new MRI will be performed at the center),
• Using a highly effective method of contraception (failure rate <1%) for the entire duration of the follow-up period. Highly effective contraception methods are defined as one of the following: combined hormonal contraception (containing estrogen and progestin) with ovulation inhibition (oral, vaginal, or transdermal), progestin-only hormonal contraception with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormonal system (IUS), condoms, bilateral tubal occlusion, vasectomized partner, or sexual abstinence,
• Having a negative urine pregnancy test on the day of the procedure,
• Having signed the informed consent form for the study at the M-1 visit.

Критерии исключения

• Pregnant or planning a pregnancy during the entire study period,
• Currently breastfeeding,
• Refusal to use effective contraception during the study and for 6 months after its completion,
• Contraindications to botulinum toxin, including:
• Generalized disorders of muscular activity (e.g., myasthenia gravis, Lambert-Eaton syndrome),
• Ongoing treatment with aminoglycosides, peripheral muscle relaxants, or amino-4-quinolines,
• Hypersensitivity to the active substance, human albumin, or sucrose,
• Bleeding disorders or current treatment with anticoagulants,
• Ongoing vaginal or upper genital tract infection,
• Participation in another interventional clinical trial,
• Inability to cooperate or understand the study requirements in a way that would allow strict adherence to the protocol,
• Subject to legal protection measures (e.g., guardianship, curatorship, or judicial protection),
• Not affiliated with the French social security system,
• Unable to access the internet to complete questionnaires at Month 1 and Month 6.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 8 центров

• Clinique axium / Centre resilience — Aix-en-Provence
• CHU Angers — Angers
• CHU Brest — Brest
• CHU Lille — Lille
• Hôpital de la Croix-Rousse — Lyon
• CHU Nantes — Nantes
• Clinique Brétéché — Nantes
• CHU Rennes — Rennes

Идентификаторы

NCT: NCT06995287 · RC24_0428 · 2025-520638-53-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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