Effectiveness of Magnetic Stimulation in the Treatment of Female UUI.

Urinary Incontinence Clinical Trial

Official title:

Randomized, Sham-controlled Study on the Effectiveness of Magnetic Stimulation in the Treatment of Female Urgency Urinary Incontinence.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735522
• Other study ID #: UMCL-UUI
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: May 2023

Study information

• Verified date: February 2023
• Source: University Medical Centre Ljubljana
• Contact: David Lukanovic, MD
• Phone: +38615226200
• Email: david.lukanovic[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Urinary incontinence is becoming an increasingly common health, social and economic problem. The prevalence of urinary incontinence is estimated at 55% of the entire female population. Urgency urinary incontinence (UUI) is the least common subtype of urinary incontinence but has debilitating symptoms that lead to a decrease in quality of life. Ultimately, the urogynegology field does not have many successful types of treatments for this specific subtype. Extracorporeal magnetic stimulation of the pelvic floor is a type of conservative management that produces a magnetic field, which induces controlled depolarization of the nerves, resulting in pelvic muscle contraction and sacral S2-S4 roots neuromodulation. Therefore, it relieves symptoms of UUI and improves quality of life. There was no randomized, sham-controlled study published that researched the effectiveness of magnetic stimulation in the treatment of UUI that evaluated the success with subjective and objective methods, such as urodynamic studies. The aim of this study was to assess the efficacy of magnetic stimulation in the treatment of urgency urinary incontinence.

Description:

RATIONALE: The FDA approved extracorporeal magnetic stimulation as a form of conservative treatment of urinary incontinence in 1998. Since then, the studies focused mainly on magnetic stimulation's effectiveness in treating stress urinary incontinence. There are five studies that assessed the efficacy of magnetic stimulation in the treatment of urgency urinary incontinence. Only one was randomized and sham-controlled, others were not. Three studies used urodynamic studies to assess the effectiveness of magnetic stimulation treatment, but those studies were not randomized or sham-controlled. The EAU guidelines, therefore, do not recommend extracorporeal magnetic stimulation as a treatment option for urinary incontinence for the lack of evidence. AIM OF THE STUDY: The study will evaluate the efficacy of magnetic stimulation as a type of conservative treatment in patients with urgency urinary incontinence. After evaluating previously conducted studies, the investigators decided to conduct the first randomized, sham-controlled study that evaluated the effectiveness of magnetic stimulation as a treatment for urgency urinary incontinence with subjective and objective measures. METHODS: the study will be randomized and sham controlled with 40 enrolled patients. The patients will be allocated in the active or sham arm in a ratio of 2:1. The patients will be recruited from the UMC Ljubljana outpatient urogynecologic clinic. All eligible patients will be invited to participate in our study by phone. STATISTICAL ANALYSES: The results will be analysed with the Kolmogorov-Smirnov test and two-way ANOVA with repeated measures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• urgency urinary incontinence proved by urodynamic studies
• 18 years of age

Exclusion Criteria:

• pregnancy
• cystitis or other active infections
• stress or mixed urinary incontinence
• prolapse of pelvic organs with POP-Q score greated than 2
• fecal incontinence
• severe medical conditions (e.g. active treatment of cancer)
• connective tissue disease
• neurologic disease

Related Conditions & MeSH terms

• Enuresis
• Pelvic Floor Disorders
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Device:
• Extracorporeal magnetic stimulation
Extracorporeal magnetic stimulation is a technique based on Faraday's law of magnetic induction, approved by the United States Food and Drug Administration in 1998, for conservative treatment of urinary incontinence. It generates electrical activity, which induces controlled depolarization of the nerves, resulting in pelvic muscle contraction and sacral S2-S4 roots neuromodulation. The patient seats in the chair fully clothed.

Other:
• Sham
The same chair as is used in the active group with the magnetic field density at the lower 2% resulting in negligible efficacy.

Locations

Country	Name	City	State
Slovenia	Department of Gynecology, Division of Gynecology and Obstetrics, Ljubljana University Medical Center	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

References & Publications (3)

He Q, Xiao K, Peng L, Lai J, Li H, Luo D, Wang K. An Effective Meta-analysis of Magnetic Stimulation Therapy for Urinary Incontinence. Sci Rep. 2019 Jun 24;9(1):9077. doi: 10.1038/s41598-019-45330-9. — View Citation

Lukanovic D, Kunic T, Batkoska M, Matjasic M, Barbic M. Effectiveness of Magnetic Stimulation in the Treatment of Urinary Incontinence: A Systematic Review and Results of Our Study. J Clin Med. 2021 Nov 8;10(21):5210. doi: 10.3390/jcm10215210. — View Citation

Yamanishi T, Homma Y, Nishizawa O, Yasuda K, Yokoyama O; SMN-X Study Group. Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. Int J Urol. 2014 Apr;21(4):395-400. doi: 10.1111/iju.12289. Epub 2013 Oct 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the ICIQ-UI SF score	Difference in the score of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) questionnaire. The scoring scale is 0-21 points. Lower score means better outcome.	Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.
Primary	Change in voiding diary 1	Difference in the mean voided volume. Higher mean voided volume means better outcome.	Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.
Primary	Change in voiding diary 2	Difference in the mean number of incontinence episodes. Lower number of incontinence episodes means better outcome.	Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.
Primary	Change in voiding diary 3	Difference in the mean number of micturitions. Lower number of micturitions means better outcome.	Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.
Primary	Change in urodynamic studies 1	Difference in the volume at first desire to void. Higher volume means better outcome.	Before the treatment and 3 months after the treatment.
Primary	Change in urodynamic studies 2	Difference in the maximum cystometric capacity. Higher volume means better outcome.	Before the treatment and 3 months after the treatment.
Secondary	Change in UDI-6 score	Difference in the score of the Urinary Distress Inventory Short Form (UDI-6) questionnaire. Score values go from 0 to 100. Lower score means better outcome.	Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.
Secondary	Change in IIQ-7 score	Difference in the score of the Incontinence Impact questionnaire Short Form (IIQ-7) questionnaire. Scores go from 0 to 100 with lower score meaning better outcome.	Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.
Secondary	Change in PISQ-12 score	Difference in the score of The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Scores go from 0 to 48 with higher score meaning better outcome.	Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.
Secondary	Change in King's Health questionnaire	Difference in the score of the King's health questionnaire. Scores go from 0 to 100. With lower score meaning better outcome.	Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.