Endometriosis, Dysmenorrhea
Conditions
Keywords
dysmenorrhea,, pelvic pain, dyspareunia, endometriosis
Brief summary
Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An altered immune system with elevated levels of cytokines in the peritoneal fluid as well as increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects related to hormonal treatments. A double blind randomized clinical trial, was carried out to evaluate pertubation with lignocaine as a therapy for dysmenorrhea.
Interventions
DRUGLignocaine
Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
DRUGRingers Solution
Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Sponsors
Region Stockholm
Isifer AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 20 years * endometriosis verified by laparoscopy * dysmenorrhea or pelvic pain defined as a pain-score of \>50 mm (VAS) * normal Fallopian tubes * regular menstrual cycles 21-35 days * treatment with oral contraceptives (OC) ongoing \> 1 month and continued during the trial * previous hormonal treatment discontinued \> 1 month (OC, gestagens) and \> 6 months (GnRH) * no wish for pregnancy during the study * normal Pap-smear * negative Chlamydia-test * negative pregnancy-test * informed consent given and signed
Exclusion criteria
* Continuous treatment with medication that may increase risk for infection - clinical signs of pelvic inflammatory disease * hyperreactivity to local anesthesia * fibroids \> 2 cm * ongoing treatment with GnRH-analog * ongoing continuous treatment with high dose gestagens * pregnancy * peritubal adhesions * occluded Fallopian tubes * inability to understand information or comply with the study procedures * participation in a clinical study within one year before the present study * any disease or laboratory finding considered of importance by the investigator not to include the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale. | After three pertubations | The pain-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatments=baseline for evaluation) and thereafter during 2nd, 3rd, 4 th, 7th, 10th and 13th menstrual periods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life-questionnaire (validated), EHP-30 | At the 7th menstruation i.e. after approximately 6 months. | The Quality of life-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatment=baseline for evaluation) and thereafter during 7th and 13th menstrual period. |
Countries
Sweden
Outcome results
None listed