Efficacy of Magnetic Stimulation for Stress Urinary Incontinence

A Randomized, Double-blind, Placebo Controlled Clinical Trial to Investigate the Effects of Transpelvic Magnetic Stimulation (Using QRS®-1010 PelviCenter) in Patients With Stress Urinary Incontinence.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01924728

Enrollment

120

Registered

2013-08-16

Start date

2013-09-30

Completion date

2016-02-29

Last updated

2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Brief summary

The aim of the study is to investigate the effects of QRS®-1010 PelviCenter in female patients with stress urinary incontinence. Based on the available data on magnetic stimulation, the investigators hypothesize that magnetic stimulation via QRS®-1010 PelviCenter will reduce the number and amount of urinary leakage upon exertion as well as improve patients' quality of life.

Detailed description

A total of 120 female patients will be randomly assigned into two treatment groups (active arm and sham arm) in a 1:1 ratio. The standard QRS®-1010 PelviCenter treatment plan involves 16 sessions of 20 minutes each. Each subject will attend 2 sessions per week (total 16 sessions).

Interventions

DEVICEMagnetic stimulation

50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles

DEVICESham magnetic stimulation

50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female aged at least 21 years old * Demonstration of stress urinary incontinence by vaginal examination with half full bladder (200 to 250ml) * ICIQ UI SF score ≥ 6 points * Able and agree to carry out one hour pad test

Exclusion criteria

* Acute severe infections * Urinary tract infections and hematuria, active vaginal lesions or infections * Pelvic organ prolapse stage III and IV, severe urethral sphincter weakness/defect, suspected fistula * Severe cardiac arrhythmia * Cardiac pacemaker or other implanted metallic devices * History of pelvic irradiation * Pregnant, or actively trying to conceive. * Neurologic conditions such as epilepsy, Parkinson disease, multiple sclerosis * Patient who has been treated with electromagnetic stimulation * Concurrent medications with alpha-adrenergic antagonists (e.g. terazosin, tamsulosin, doxazosin), diuretics, serotonin/norepinephrine reuptake inhibitors (SNRIs) or any other medications known to worsen incontinence. * Post void residual volume of ≥ 200ml * Random blood sugar \>10 mmol/L * Patient who had pelvic or gynaecological surgery for less than three weeks * Patient scheduled for pelvic or gynaecological surgery in the next eight weeks

Design outcomes

Primary

Measure	Time frame
Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF)	Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment

Secondary

Measure	Time frame
Change in Incontinence Episode Frequency (IEF)	Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Change in 1-hour exercise (stress) pad test	Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Change in Patient Global Impression of Improvement (PGI-I)	Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Change in International consultation on incontinence questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)	Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026