Trial record 18 of 48 for:    Open Studies | "Urinary Incontinence, Stress"

Efficacy of Magnetic Stimulation for Stress Urinary Incontinence

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 24, 2014
Last verified: September 2014
  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
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
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

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 24, 2014
Health Authority: Malaysia: Ministry of Health

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

ClinicalTrials.gov processed this record on September 30, 2014