Efficacy of Magnetic Stimulation for Stress Urinary Incontinence

February 19, 2016 updated by: Lim Renly, QRS Asia Sdn Bhd

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Penang, Malaysia, 10450
        • Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Incontinence Episode Frequency (IEF)
Time Frame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
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
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
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
Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QRS Asia Sdn Bhd

Collaborators

Universiti Sains Malaysia
Island Hospital
Penang Adventist Hospital

Investigators

  • Principal Investigator: Liong Men Long, MBBS, Island Hospital, Penang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (ESTIMATE)

August 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QRSPelvicenter

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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