Pelvic Floor Magnetic Stimulation in Women With Idiopathic Overactive Bladder

Overview

In clinical practice, Bladder Traininhg (BT) and Magnetic stimulation (MS) are frequently used together in the treatment of women with idiopathic overactive bladder (OAB). Up to our knowledge, there is no study evaluating the combined effect of magnetic stimulation and bladder training in women with idiopathic OAB in the literature. Moreover, there is no recommendation on conservative treament combinations in the guidelines due to insufficient data. At this stage, studies are needed to determine whether it will be effective to use MS in combination with other conservative treatment options. In addition, in the light of our clinical experience, we think that this issue is still open for research. In our study, adding MS to BT in women with idiopathic AAM is thought to contribute additionally to the efficacy of treatment with BT.

Our study is the first prospective randomized controlled trial that compares the efficacy of BT and BT plus MS in women with idiopathic OAB. In this study, we aimed to evaluate the efficacy of MS added to BT on incontinence-related QoL and clinical parameters in women with idiopathic OAB.

Full Title of Study: “Combined Effect of Pelvic Floor Magnetic Stimulation and Bladder Training in Women With Idiopathic Overactive Bladder: A Prospective Randomised Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2021

Detailed Description

This study is a prospectively randomized, controlled trial. The trial is held at Urogynecological Rehabilitation Unit of XXXX, Physical Medicine and Rehabilitation Department between September 2020 and November 2021. The local ethics committee approve the study (approvel no: 60116787-020/37878). Patients are informed about the purpose and contents of the study and all women give written consent to participate.

By using a random number generator, all patients which included the study were randomized into two groups as follows: The Group 1 received BT program alone, the Group 2 received BT plus MS.

Group 1: Bladder Training (BT) – Control group All women were informed about BT for 30 minutes. Then it was given as a written brochure to be implemented as a home program.

BT, consisting of four stages, did not contain any PFMT programs in two groups.

Group 2: BT plus MS Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is in serted by this magnetic field, an eddy current flow is generated. This eddy current stimulates nerve or muscle of the pelvic floor. To apply MS, the device was set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature (10,13-15). When setting the device at each treatment session, patients were interviewed so that they received stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) (10). MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. MS sessions were performed by other physician.

Interventions

  • Device: Magnetic stimulation -Armchair type (MS)
    • MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.
  • Other: Bladder Training (BT)
    • Bladder Training (BT)

Arms, Groups and Cohorts

  • Active Comparator: Group 1: Bladder Training (BT)
    • BT, consisting of four stages, did not contain any PFMT programs in all groups. In these stages, including urgency supression strategies, it was aimed to delay urination, to inhibit detrusor contraction and to prevent urgency; by squeezing the PFM several times in a row (women were encouraged to pause/stop their work, sit down if possible, relax the entire body and squeeze PFM repeatedly), breathing deeply, giving their attention to another job for a while and self-motivating (I can do it, I can check the urination, etc.).
  • Experimental: Group 2: Bladder Training+Magnetic Stimulation
    • Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is in serted by this magnetic field, an eddy current flow is generated. This eddy current stimulates nerve or muscle of the pelvic floor. To apply MS, the device was set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature. When setting the device at each treatment session, patients were interviewed so that they received stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) .

Clinical Trial Outcome Measures

Primary Measures

  • Incontinence episodes
    • Time Frame: 6 weeks
    • Patients with a 50% or greater reduction in incontinence episodes were consider positive responders

Secondary Measures

  • Severity of incontinence
    • Time Frame: 6 weeks
    • The 24-hour pad test was carried out to evaluate urinary loss.
  • Nocturia
    • Time Frame: 6 weeks
    • It was used “nocturia” from data collected with a 3-day bladder diary.
  • Frequency
    • Time Frame: 6 weeks
    • It was used “frequency” from data collected with a 3-day bladder diary.
  • Number of pads
    • Time Frame: 6 weeks
    • It was used “number of pads” from data collected with a 3-day bladder diary.
  • Symptom severity
    • Time Frame: 6 weeks
    • Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in patients with in the study.
  • QoL
    • Time Frame: 6 weeks
    • The Incontinence Impact Questionnaire (IIQ-7) scale which has great validity in studies was used to assess the patient’s QoL associated with incontinence problem
  • Sexual Functions
    • Time Frame: 6 weeks
    • The Female Sexual Function Index (FSFI) is a valid, reliable, and anonymously designed ques¬tionnaire with six areas (desire, subjective arousal, lubrica¬tion, orgasm, satisfaction, pain), and includes 19 questions that measure female sexual function.
  • Cure and improvement rate
    • Time Frame: 6 weeks
    • In 24-hour pad test, 1.3 gr under of it was considered as a cure. The improvement was assessed in terms of 50% and more reduction in wet weight compared to baseline measurements in the 24-hour pad test

Participating in This Clinical Trial

Inclusion Criteria

Women over the age of 18 with clinical diagnosis of idiopathic OAB Urodynamically confirmed detrusor overactivity (the presence of detrusor contractions in the filling phase of saline cystometry) Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks Able to give written, informed consent Able to understand the precedures, advantages and possible side effects Willing and able to complate the voiding diary and QoL questionnaire The strength of PFM 3/5 and more

Exclusion Criteria

History of BT, MS therapy Pregnancy or intention to become pregnant during the study Current vulvovaginitis or urinary tract infections or malignancy More than stage 2 according to the pelvic organ prolapse quantification (POP-Q) Cardiac pacemaker, implanted defibrillator, coronary artery stent Ongoing treatment for arrhythmia Lower abdominal pain or dysmenorrhea yet to be diagnosed Electronic device or metallic implant applied to areas between the lumbar region and lower extremities Previous urogyneceological surgery within 3 months Ongoing surgical treatment or treatment with implantable devices for urinary incontinence or use of intrauterin copper devices Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology Ultrasonographic evidence of PVR volume more than 100 ml

Gender Eligibility: Female

Women over the age of 18 with clinical diagnosis of idiopathic OAB and urodynamically confirmed detrusor overactivity (the presence of detrusor contractions in the filling phase of saline cystometry)

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pamukkale University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Necmettin Yildiz, PAU – Pamukkale University

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