Pelvic Floor Magnetic Stimulation in Women With Idiopathic Overactive Bladder

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450511
• Other study ID #: 60116787-020/37878
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 29, 2021

Study information

• Verified date: October 2022
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 29, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ?lling 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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli	Kinikli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinence episodes	Patients with a 50% or greater reduction in incontinence episodes were consider positive responders	6 weeks
Secondary	Severity of incontinence	The 24-hour pad test was carried out to evaluate urinary loss.	6 weeks
Secondary	Nocturia	It was used "nocturia" from data collected with a 3-day bladder diary.	6 weeks
Secondary	Frequency	It was used "frequency" from data collected with a 3-day bladder diary.	6 weeks
Secondary	Number of pads	It was used "number of pads" from data collected with a 3-day bladder diary.	6 weeks
Secondary	Symptom severity	Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in patients with in the study.	6 weeks
Secondary	QoL	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	6 weeks
Secondary	Sexual Functions	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.	6 weeks
Secondary	Cure and improvement rate	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	6 weeks