Pelvic Floor Magnetic Stimulation in Women With Idiopathic Overactive Bladder

NCT ID: NCT04450511

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-11-29

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.

Detailed Description

This study is a prospectively randomized, controlled trial. The trial is held at Urogynecological Rehabilitation Unit of University Hospital, Physical Medicine and Rehabilitation Department between September 2020 and November 2021. The local ethics committee approve the study (approval 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 pelvic floor muscle (PFM) training 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 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 (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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Bladder Training (BT)

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.).

Group Type: ACTIVE_COMPARATOR

Bladder Training (BT)

Intervention Type: OTHER

Bladder Training (BT)

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 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) .

Group Type: EXPERIMENTAL

Magnetic stimulation -Armchair type (MS)

Intervention Type: DEVICE

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

Bladder Training (BT)

Intervention Type: OTHER

Bladder Training (BT)

Interventions

Magnetic stimulation -Armchair type (MS)

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

Intervention Type: DEVICE

Bladder Training (BT)

Bladder Training (BT)

Intervention Type: OTHER

Other Intervention Names

Extracorporeal magnetic stimulation

Eligibility Criteria

Inclusion Criteria

1. Women over the age of 18 with clinical diagnosis of idiopathic OAB

2. Urodynamically confirmed detrusor overactivity (the presence of detrusor contractions in the filling phase of saline cystometry)

3. Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks

4. Able to give written, informed consent

5. Able to understand the procedures, advantages and possible side effects

6. Willing and able to complete the voiding diary and QoL questionnaire

7. The strength of PFM 3/5 and more

Exclusion Criteria

1. History of BT, MS therapy

2. Pregnancy or intention to become pregnant during the study

3. Current vulvovaginitis or urinary tract infections or malignancy

4. More than stage 2 according to the pelvic organ prolapse quantification

5. Cardiac pacemaker, implanted defibrillator, coronary artery stent

6. Ongoing treatment for arrhythmia

7. Lower abdominal pain or dysmenorrhea yet to be diagnosed

8. Electronic device or metallic implant applied to areas between the lumbar region and lower extremities

9. Previous urogynecological surgery within 3 months

10. Ongoing surgical treatment or treatment with implantable devices for urinary incontinence or use of intrauterine copper devices

11. Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology

12. Ultrasonographic evidence of post voiding residual volume more than 100 ml

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Necmettin Yildiz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pamukkale University

Denizli, Kınıklı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

60116787-020/37878

Identifier Type: -

Identifier Source: org_study_id