NL-OMON50815RecruitingNot Applicable
Spinal Cord Stimulation for intractable chronic lower abdominal neuropathic pain caused by endometriosis - Spinal Cord Stimulation for Endometriosis pain
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Patients with endometriosis/ adenomyosis confirmed at surgery and without
- •options for further surgical treatment.
- •- Premenopausal woman aged >= 18 years
- •- Patients with at least one of the endometriosis related pain symptoms:
- •dysmenorrhea, pelvic pain or dyspareunia.
- •- Mean pain NRS of at least 5 (scale 0-10).
- •- The pain complaints are therapy resistant (including hormonal, medical
- •and/or surgical options)
- •- Refractory pain; Before neuromodulation patient has tried: Paracetamol,
- •NSAIDs, Anti neuropathic pain therapy, TENS
- •- Neurologic exam without marked motor deficit.
- •- Meets all the inclusion criteria for the implantation of a neurostimulation
- •system as typically utilized in the study center.
- •- Subject has been screened by a multi-disciplinary panel including a
- •psychologist and deemed suitable for implantation
- •- Subject is able and willing to comply with the follow-up schedule and protocol
- •- Subject is able to provide written informed consent
Exclusion Criteria
- •- Female subject of childbearing potential is pregnant/nursing or plans to
- •become pregnant during the course of the study
- •- The presence of any malignancy
- •- BMI >=35
- •- Subject currently has an active implantable device including ICD, pacemaker,
- •spinal cord stimulator or intrathecal drug pump
- •- Subject is unable to operate the device
- •- Previous Neurostimulation therapy
Investigators
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