Pelvic Floor Magnetic Stimulation in Women With Idiopathic Overactive Bladder
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- STATUS
- Recruiting
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- participants needed
- 76
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- sponsor
- Pamukkale University
Summary
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.
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 eld, an eddy current ow is generated. This eddy current stimulates nerve or muscle of the pelvic oor. To apply MS, the device was set to generate its maximum stimuli, with a stimulation pulse width of 200 s 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.
Details
| Condition | Reduction of Urge Incontinence Episodes After the Magnetic Stimulation Added to Bladder Training in Women With Idiopathic Overactive Bladder |
|---|---|
| Age | 18years - 100years |
| Treatment | Magnetic stimulation -Armchair type (MS), Bladder Training (BT) |
| Clinical Study Identifier | NCT04450511 |
| Sponsor | Pamukkale University |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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