Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal.
Joop P van de Merwe, Jørgen Nordling, Pierre Bouchelouche...
https://pubmed.ncbi.nlm.nih.gov/17900797Actively Recruiting
Led by Wake Forest University Health Sciences · Updated on 2026-05-07
75
Participants Needed
1
Research Sites
21 weeks
Total Duration
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
This research aims to evaluate the safety and effectiveness of low-frequency pulsed electromagnetic field (PEMF) therapy for female adults with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). IC/BPS is a chronic condition characterized by bladder and pelvic pain along with urinary symptoms, which significantly impact quality of life. The study addresses challenges due to the complex causes and symptom variability of IC/BPS and explores PEMF as a non-drug, non-invasive treatment option that may reduce pain and urinary symptoms over time. Participants will use a PEMF device at home consisting of a full body mat and a smaller pelvic pad. Treatment involves lying on the mat with the pad over the pelvic area and applying PEMF therapy twice daily for 8-minute sessions over 4 weeks. Study groups include active treatment with or without maintenance therapy and a sham device group that mimics the active device but emits no electromagnetic field. After the initial treatment, participants complete questionnaires at 4, 8, 12, and 16 weeks post-enrollment while either discontinuing or continuing maintenance treatment. Participants will complete assessments including pain evaluation using the Brief Pain Inventory Short Form and symptom questionnaires at baseline and at each follow-up visit. Researchers will monitor changes in pelvic pain and urinary symptoms over the 16-week period. Safety and adherence are tracked through device use and electronic questionnaires. The total participation lasts about four months, with data collected at baseline, after treatment, and during follow-up.
CONDITIONS
Investigation of PEMF Therapy for Female Patients With IC/BPS
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants self-administer pulsed electromagnetic field (PEMF) therapy or sham therapy twice a day at home for 8-minute sessions over a 4-week period using a full body mat and targeted pelvic pad.
Twice daily sessions at home
Duration - 3 months
Participants complete electronic questionnaires monthly during the last week of the month for 3 months to assess the duration of benefit. Some participants continue maintenance PEMF therapy for one week per month during this period.
Monthly electronic questionnaire completion; maintenance therapy for some participants involves weekly home use during the last week of each month
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
S
Stephen J Walker, PhD
K
Kaylee A Ferrara, BS
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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