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NCT Number: NCT05735522

Effectiveness of Magnetic Stimulation in the Treatment of Female UUI.

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in the ICIQ-UI SF score

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

    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.

  2. Change in voiding diary 1

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

    Difference in the mean voided volume. Higher mean voided volume means better outcome.

  3. Change in voiding diary 2

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

    Difference in the mean number of incontinence episodes. Lower number of incontinence episodes means better outcome.

  4. Change in voiding diary 3

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

    Difference in the mean number of micturitions. Lower number of micturitions means better outcome.

  5. Change in urodynamic studies 1

    Time frame: Before the treatment and 3 months after the treatment.

    Difference in the volume at first desire to void. Higher volume means better outcome.

  6. Change in urodynamic studies 2

    Time frame: Before the treatment and 3 months after the treatment.

    Difference in the maximum cystometric capacity. Higher volume means better outcome.

Secondary outcomes

  1. Change in UDI-6 score

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

    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.

  2. Change in IIQ-7 score

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

    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.

  3. Change in PISQ-12 score

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

    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.

  4. Change in King's Health questionnaire

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

    Difference in the score of the King's health questionnaire. Scores go from 0 to 100. With lower score meaning better outcome.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University of Ljubljana, Faculty of Medicine

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 21, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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