Efficacy of Magnetic Stimulation for Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924728
• Other study ID #: QRSPelvicenter
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: February 19, 2016
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: QRS Asia Sdn Bhd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Magnetic stimulation
50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles
• Sham magnetic stimulation
50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles

Locations

Country	Name	City	State
Malaysia	Island Hospital	Penang

Sponsors (4)

Lead Sponsor	Collaborator
QRS Asia Sdn Bhd	Island Hospital, Penang Adventist Hospital, University of Science Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Incontinence Episode Frequency (IEF)		Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment	No
Secondary	Change in 1-hour exercise (stress) pad test		Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment	No
Secondary	Change in Patient Global Impression of Improvement (PGI-I)		Week 4, 8. Follow-up at 3-,6- and 12-months post treatment	No
Secondary	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	No