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Efficacy of Magnetic Stimulation for Stress Urinary Incontinence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01924728
First Posted: August 16, 2013
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Science Malaysia
Island Hospital
Penang Adventist Hospital
Information provided by (Responsible Party):
Lim Renly, QRS Asia Sdn Bhd
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence Device: Magnetic stimulation Device: Sham magnetic stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Lim Renly, QRS Asia Sdn Bhd:

Primary Outcome Measures:
  • Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF) [ Time Frame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment ]

Secondary Outcome Measures:
  • Change in Incontinence Episode Frequency (IEF) [ Time Frame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment ]
  • Change in 1-hour exercise (stress) pad test [ Time Frame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment ]
  • Change in Patient Global Impression of Improvement (PGI-I) [ Time Frame: 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) [ Time Frame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment ]

Enrollment: 120
Study Start Date: September 2013
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Magnetic stimulation
Active magnetic stimulation delivered to the pelvic floor muscles
Device: Magnetic stimulation
50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles
Sham Comparator: Sham magnetic stimulation
Sham magnetic stimulation delivered to the pelvic floor muscles
Device: Sham magnetic stimulation
50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924728


Locations
Malaysia
Island Hospital
Penang, Malaysia, 10450
Sponsors and Collaborators
QRS Asia Sdn Bhd
University of Science Malaysia
Island Hospital
Penang Adventist Hospital
Investigators
Principal Investigator: Liong Men Long, MBBS Island Hospital, Penang
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lim Renly, M. Pharm, QRS Asia Sdn Bhd
ClinicalTrials.gov Identifier: NCT01924728     History of Changes
Other Study ID Numbers: QRSPelvicenter
First Submitted: August 14, 2013
First Posted: August 16, 2013
Last Update Posted: February 23, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders