Efficacy of Transpelvic Magnetic Stimulation for Stress Urinary Incontinence

This study is currently recruiting participants.
Verified December 2013 by QRS Asia Sdn Bhd
Sponsor:
Collaborators:
University of Science Malaysia
Island Hospital
Information provided by (Responsible Party):
Lim Renly, QRS Asia Sdn Bhd
ClinicalTrials.gov Identifier:
NCT01924728
First received: August 14, 2013
Last updated: December 3, 2013
Last verified: December 2013
  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 transpelvic 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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, 12, 20, 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Incontinence Episode Frequency (IEF) [ Time Frame: Baseline, Week 4, 8, 12, 20, 32 ] [ Designated as safety issue: No ]
  • Change in 1-hour exercise (stress) pad test [ Time Frame: Baseline, Week 4, 8, 12, 20, 32 ] [ Designated as safety issue: No ]
  • Change in Patient Global Impression of Improvement (PGI-I) [ Time Frame: Week 4, 8, 12, 20, 32 ] [ Designated as safety issue: No ]
  • Change in International consultation on incontinence questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) [ Time Frame: Baseline, Week 4, 8, 12, 20, 32 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2013
Estimated Study Completion Date: August 2016
Estimated 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
5Hz 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 25 minutes each (20 minutes magnetic therapy plus 5 minutes relax therapy). Each subject will attend 2 sessions per week (total 16 sessions).

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female aged between 21 to 70 years old
  • Demonstration of stress urinary incontinence by vaginal examination with half full bladder (200 to 250ml)
  • ICIQ UI SF score > 5 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01924728

Contacts
Contact: Lim Renly, M. Pharm renly_lim@hotmail.com

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

No publications provided

Responsible Party: Lim Renly, M. Pharm, QRS Asia Sdn Bhd
ClinicalTrials.gov Identifier: NCT01924728     History of Changes
Other Study ID Numbers: QRSPelvicenter
Study First Received: August 14, 2013
Last Updated: December 3, 2013
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014