Spinal Cord Stimulation for Intractable Chronic Lower Abdominal Neuropathic Pain Caused by Endometriosis

NCT05558540 | Unknown FDA Device

• 1 other identifier: NL76287.018.21
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a chronic, inflammatory disease where endometrium-like tissue is present outside the uterus. Nerve cells in the proximity of this tissue express cytokine receptors causing a signaling cascade. This results in active cross-talk between endometriosis and nerves, causing pelvic pain. Other symptoms associated with endometriosis are cyclical such as dysmenorrhea and dysuria, and non-cyclical such as dyspareunia. Despite adequate disease management, women can still experience endometriosis-related pain. A recent development proven to be efficient in treatment of neuropathic pain, is Spinal Cord Stimulation (SCS). It is also thought to be effective in the treatment of visceral pain. Several studies found Spinal Cord Stimulation (SCS) to be effective in the reduction of endometriosis-related pelvic pain. However, scientific evidence on the efficacy of SCS in visceral pain is limited.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Change in pain severity at 6 month follow-up

  An aimed pain reduction of at least 30% or 2 points reduction in mean NRS pain score (0-10). This is measured using a pain diary.

  6 months

Secondary Outcomes (9)

• Change in Mean pain from baseline until 12 month follow-up

  12 months

• Patient's global impression of change

  12 months

• Change in quality of life

  12 months

• Change in quality of life

  12 months

• Change in fatigue

  12 months

Study Arms (1)

Implantation with spinal cord stimulator

EXPERIMENTAL

Women participating in the trial will receive a spinal cord stimulator (SCS). Women will first undergo a trial implantation period of 14 days. When the trial period is considered successfull (at least 50 percent reported pain reduction) women will receive definitive placement of the SCS. Normal lead placement( bilateral TH8-12) and different stimulation types will be used (FAST, subthresholdand/orCombination). When participating in the trial, women will be asked to complete a set of questionnaires on several occasions, i.e. at baseline, 3 months after implantation, 6 months after implantation and 12 months after implantation.

Device: spinal cord stimulator

Interventions

spinal cord stimulator DEVICE

By continuous electrical stimulation of the nerve causing endometriosis-related pain, painful inputs to the spinal cord and brain can be reduced or even eliminated. The electrical stimulation is performed by the spinal cord stimulator (SCS).

Also known as: neuromodulation

Implantation with spinal cord stimulator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Women with female reproductive organs can be diagnosed with endometriosis. Endometriosis does not occur in the male population. Therefore, only women can be included in the trial. Patients identifying as female but without female reproductive organs can unfortunately not participate in the trial.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal woman aged ≥ 18 years
• Patients with endometriosis/ adenomyosis confirmed at surgery macroscopically and without options for further surgical treatment.
• Patients with at least one of the endometriosis related pain symptoms: dysmenorrhea, pelvic pain or dyspareunia. With a 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.
• 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

You may not qualify if:

• Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study.
• The presence of malignancy
• 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

Sponsors & Collaborators

• Prof. Velja Mijatovic: lead
• Boston Scientific Group: collaborator

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Related Publications (2)

• Bajaj P, Bajaj P, Madsen H, Arendt-Nielsen L. Endometriosis is associated with central sensitization: a psychophysical controlled study. J Pain. 2003 Sep;4(7):372-80. doi: 10.1016/s1526-5900(03)00720-x.

  PMID: 14622679 RESULT

• van Haaps AP, Kallewaard JW, Bieze M, Erwteman M, Nap A, Hollmann MW, Schreurs AMF, Mijatovic V. Spinal-Cord Stimulation for Intractable, Visceral Pain Associated With Endometriosis: Positive Results of a Feasibility Study. Neuromodulation. 2025 Dec 3:S1094-7159(25)01143-2. doi: 10.1016/j.neurom.2025.10.067. Online ahead of print.

  PMID: 41335088 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Due to the nature of the intervention, masking is not possible. All participants will receive a SCS.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Doctor

Model Details: All women participating in the trial will receive a SCS. Women will first undergo a trial period of 14 days. If succesful (\>50% pain reduction), women will receive a permanently implanted SCS. The follow-up period will enclose 12 months. There is an aimed sample size of 15 participants. However, due to financial limitations, inclusion will stop after 10 women have been succesfully implanted with a permanent SCS.

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 28, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)