PEMF Therapy for Interstitial Cystitis/Bladder Pain Syndrome
This study is looking into how safe and effective a non-drug treatment called Pulsed Electromagnetic Field (PEMF) therapy is for women with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). The study will give participants a BEMER PEMF device, which includes a full-body mat and a pelvic pad, or a sham device that looks identical but doesn't emit a field. Researchers want to see if using the PEMF device can reduce bladder and pelvic pain, as measured by a pain questionnaire. To join, you must be a woman between 18 and 80 years old with a confirmed diagnosis of IC/BPS and a current pain score of 6 or higher. The study is currently recruiting participants.
- Study design
- This is an interventional study planning to enroll 75 female participants. It compares an active PEMF device to a sham (inactive) PEMF device.
- What's involved
- Data will be collected at the start of the study, after 4 weeks of using the PEMF therapy, and then at 8, 12, and 16 weeks after enrollment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 16 weeks after enrollment to measure changes in pelvic pain.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Investigation of PEMF Therapy for Female Patients With IC/BPS
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Stephen J Walker, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Pelvic pain, as measured by the Brief Pain Inventory (BPI) Short FormBaseline
The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.
- Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short FormWeek 4
The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.
- Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short FormWeek 8
The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.
- Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short FormWeek 12
The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.
- Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short FormWeek 16
The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.