Pulsed Electromagnetic Field Therapy for Women with Interstitial Cystitis/Bladder Pain Syndrome
This study aims to evaluate the effectiveness of pulsed electromagnetic field therapy in reducing pelvic pain for women suffering from interstitial cystitis or bladder pain syndrome.
Pulsed Electromagnetic Field (PEMF) Device
+ Sham Pulsed Electromagnetic Field (PEMF) Device
Urogenital Diseases+5
+ Urinary Bladder Diseases
+ Cystitis
Treatment Study
Summary
Study start date: August 29, 2022
Actual date on which the first participant was enrolled.This study explores the use of Pulsed Electromagnetic Field (PEMF) therapy to help women experiencing Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), a condition causing chronic pelvic pain and urinary issues. IC/BPS is challenging to treat because it involves a mix of symptoms and potential causes, such as inflammation and nerve problems. Current treatments often do not fully relieve symptoms, so finding new solutions is important. PEMF therapy, which has been used safely for conditions like arthritis and chronic pain, may offer a new, non-invasive way to reduce pain for women with IC/BPS, potentially improving their quality of life. In the study, participants receive PEMF therapy and are monitored over a four-month period to see if it reduces their pain and improves their symptoms. Researchers use a questionnaire called the Brief Pain Inventory (BPI) Short Form to measure changes in pain levels and how pain affects daily activities. This questionnaire helps track whether the therapy makes a significant difference in the participants' lives. The study also investigates whether continued PEMF treatments provide lasting benefits. The safety and effectiveness of PEMF therapy are key focus points, with successful results potentially leading to larger studies in the future.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Previously established clinical diagnosis of IC/PS * Current numeric rating scale (NRS) score of ≥ 6 * History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia * No cognitive deficits Exclusion Criteria: * History of bladder, ovarian, 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 * BMI \> 40 * Residual urine of \> 100cc * Current pregnant
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Wake Forest University Health Sciences
Winston-Salem, United StatesOpen Wake Forest University Health Sciences in Google Maps