Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report (NCT04549818) | Clinical Trial Compass
UnknownNot Applicable
Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report
44 participantsStarted 2020-09-10
Plain-language summary
in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age, 18-70
* Pain localized to the pelvic and perineal region
* The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer
* The intensity of pain assessed by VAS (visual analogue pain scale) \> 7
* Importantly, the included participants should gain \> 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root
Exclusion Criteria:
* Coagulopathy
* Infection at site of maneuver
* Abnormal Psychological behavior that interfere with integrity of obtained data
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change of intensity of pain
Timeframe: The outcome will be measured at day 15 postoperatively.