Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
ID05149573

Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Led by Wake Forest University Health Sciences · Updated on 2026-05-07

75

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Investigation of PEMF Therapy for Female Patients With IC/BPS

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female adults aged 18 to 80 years
  • Previously established clinical diagnosis of Interstitial Cystitis/Bladder Pain Syndrome
  • Current numeric rating scale (NRS) score of 6 or higher for pain
  • History of cystoscopy with hydrodistension and bladder capacity measurement under anesthesia
  • No cognitive deficits
Not Eligible

You will not qualify if you...

  • History of bladder, ovarian, or vaginal cancer
  • History of urethral diverticulum
  • History of radiation cystitis
  • History of spinal cord injury or spina bifida
  • History of Parkinson's disease, multiple sclerosis, or stroke
  • Current placement of a pacemaker or metal prosthesis
  • Active urinary tract infection
  • Body mass index (BMI) greater than 40
  • Residual urine volume greater than 100cc
  • Current pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

S

Stephen J Walker, PhD

K

Kaylee A Ferrara, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

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/17900797

The role of a leaky epithelium and potassium in the generation of bladder symptoms in interstitial cystitis/overactive bladder, urethral syndrome, prostatitis and gynaecological chronic pelvic pain.

C Lowell Parsons

https://pubmed.ncbi.nlm.nih.gov/21176078