Effectiveness of Magnetic Stimulation in the Treatment of Female UUI.

NCT05735522 | Completed

• 1 other identifier: UMCL-UUI
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence; Urinary Incontinence, Urge; Pelvic Floor Disorders

Keywords

urgency urinary incontinence; urinary incontinence; magnetic stimulation; urinary urgency

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (4)

• Change in UDI-6 score

  Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.

• Change in IIQ-7 score

  Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.

• Change in PISQ-12 score

  Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.

• Change in King's Health questionnaire

  Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.

Study Arms (2)

Active group

ACTIVE COMPARATOR

We are using an extracorporeal magnetic stimulation chair with two magnetic stimulators, one under the seat and one in the backrest, that generate the magnetic field. The treatment lasts for 30 minutes and has 5 steps. Each step has a defined duration and a defined frequency of magnetic field pulsations. In each step, it is also defined, which of the magnetic field generators are working. The pulsations last for 6 seconds followed by 6 seconds of rest. Step 1: 10Hz, 7 minutes, 6 seconds on, 6 seconds off, both stimulators generate the magnetic field. Step 2: 10Hz, 4 minutes, the stimulator under the seat generates the magnetic field. Step 3: 10Hz, 7 minutes, the stimulator in the backrest generates the magnetic field. Step 4: 30Hz, 10 minutes, both stimulators generate the magnetic field. Step 5: After 5 minutes, both stimulators generate the magnetic field. During the treatment, we adjusted the magnetic field density. It varied from 2-100%. The maximum was 3 Teslas.

Device: Extracorporeal magnetic stimulation

Sham group

SHAM COMPARATOR

We are using extracorporeal magnetic stimulation, a chair with two magnetic stimulators, one under the seat and one in the backrest, that generate the magnetic field. The treatment lasts for 30 minutes and has 5 steps. We used the same program as in the active group with the difference that the magnetic field density was always at 2% so the effects of the pulsating are negligible.

Other: Sham

Interventions

Extracorporeal magnetic stimulation DEVICE

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.

Active group

Sham OTHER

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

Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana, Faculty of Medicine: collaborator

Study Sites (1)

Department of Gynecology, Division of Gynecology and Obstetrics, Ljubljana University Medical Center

Ljubljana, 1000, Slovenia

Location

Related Publications (3)

• 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.

  PMID: 34768730 BACKGROUND

• 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.

  PMID: 31235706 BACKGROUND

• 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.

  PMID: 24118165 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Urge; Pelvic Floor Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Study Officials

• Adolf Lukanović, MD, PhD

  Department of Gynecology, Division of Gynecology and Obstetrics, Ljubljana University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asist. dr.

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 21, 2023
• Study Start: February 25, 2023
• Primary Completion: November 17, 2024
• Study Completion: March 5, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 20 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of the principal investigator.For more information or to submit a request, please contact david.lukanovic@kclj.si

Locations

SL (1)