Efficacy of Magnetic Stimulation for Stress Urinary Incontinence

QRS Asia

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Sham magnetic stimulation; Device: Magnetic stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01924728

QRSPelvicenter

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: Female

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 2 patient groups

Magnetic stimulation

Active Comparator group

Description:

Active magnetic stimulation delivered to the pelvic floor muscles

Treatment:

Device: Magnetic stimulation

Sham magnetic stimulation

Sham Comparator group

Description:

Sham magnetic stimulation delivered to the pelvic floor muscles

Treatment:

Device: Sham magnetic stimulation