Pelvic Floor Magnetic Stimulation in Women With Idiopathic Overactive Bladder

NCT04450511 | Completed

• 1 other identifier: 60116787-020/37878
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

In clinical practice, Bladder Training (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 treatment 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 OAB 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.

Conditions

Urge Incontinence Episodes After the Magnetic Stimulation Added to Bladder Training in Women With Idiopathic Overactive Bladder

Keywords

idiopathic overactive bladder; bladder training; magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Incontinence episodes

  Patients with a 50% or greater reduction in incontinence episodes were consider positive responders

  6 weeks

Secondary Outcomes (8)

• Severity of incontinence

  6 weeks

• Nocturia

  6 weeks

• Frequency

  6 weeks

• Number of pads

  6 weeks

• Symptom severity

  6 weeks

Study Arms (2)

Group 1: Bladder Training (BT)

ACTIVE COMPARATOR

BT, consisting of four stages, did not contain any PFM training programs in all groups. In these stages, including urgency suppression 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.).

Other: Bladder Training (BT)

Group 2: Bladder Training+Magnetic Stimulation

EXPERIMENTAL

Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is inserted 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) .

Device: Magnetic stimulation -Armchair type (MS); Other: Bladder Training (BT)

Interventions

Magnetic stimulation -Armchair type (MS) DEVICE

MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.

Also known as: Extracorporeal magnetic stimulation

Group 2: Bladder Training+Magnetic Stimulation

Bladder Training (BT) OTHER

Bladder Training (BT)

Group 1: Bladder Training (BT); Group 2: Bladder Training+Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 procedures, advantages and possible side effects
• Willing and able to complete the voiding diary and QoL questionnaire
• The strength of PFM 3/5 and more

You may not qualify if:

• 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
• 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 urogynecological surgery within 3 months
• Ongoing surgical treatment or treatment with implantable devices for urinary incontinence or use of intrauterine copper devices
• Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
• Ultrasonographic evidence of post voiding residual volume more than 100 ml

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Kınıklı, 20100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 29, 2020
• Study Start: September 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: November 29, 2021
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)