Stress Urinary IncontinenceNCT01924728
Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
A study testing Magnetic stimulation in people with Stress Urinary Incontinence, run by QRS Asia Sdn Bhd at 1 site in Malaysia.
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteMalaysia
- Study dates
- Sep 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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).
- Conditions
- Stress Urinary Incontinence
- Being tested
- Magnetic stimulation, Sham magnetic stimulation
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic stimulationDevice
50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles
Sham magnetic stimulationDevice
50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles
| Study group | Role | What they receive |
|---|---|---|
| Magnetic stimulation | Active comparator | Active magnetic stimulation delivered to the pelvic floor muscles Receives: Device: Magnetic stimulation |
| Sham magnetic stimulation | Sham comparator | Sham magnetic stimulation delivered to the pelvic floor muscles Receives: Device: Sham magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF)
Measured: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Secondary outcomes (4)
Change in Incontinence Episode Frequency (IEF)
Measured: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Change in 1-hour exercise (stress) pad test
Measured: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Change in Patient Global Impression of Improvement (PGI-I)
Measured: 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)
Measured: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- QRS Asia Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universiti Sains Malaysia, Island Hospital, Penang Adventist Hospital
- Responsible party
- Principal investigator, Lim Renly, QRS Asia Sdn Bhd
- Investigators
- Liong Men Long, MBBS, Principal investigator, Island Hospital, Penang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924728
- Sponsor's protocol ID
- QRSPelvicenter
- Status last verified
- Feb 2016
- First submitted
- 14 Aug 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lim R, Liong ML, Leong WS, Khan NA, Yuen KH. Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial. Trials. 2015 Jun 21;16:279. doi: 10.1186/s13063-015-0803-1.
PubMed 26093910
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01924728
- Acronym / sponsor ID
- QRSPelvicenter
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- QRS Asia Sdn BhdIndustry (pharma, biotech, devices)
- Collaborators
- Universiti Sains Malaysia, Island Hospital, Penang Adventist Hospital
- Study start
- Sep 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic stimulation | Active comparator | Device: Magnetic stimulationActive magnetic stimulation delivered to the pelvic floor muscles |
| Sham magnetic stimulation | Sham comparator | Device: Sham magnetic stimulationSham magnetic stimulation delivered to the pelvic floor muscles |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic stimulation50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles | Device | Magnetic stimulation |
| Sham magnetic stimulation50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles | Device | Sham magnetic stimulation |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Derived from this study: PubMed 26093910Lim R, Liong ML, Leong WS, Khan NA, Yuen KH. Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial. Trials. 2015 Jun 21;16:279. doi: 10.1186/s13063-015-0803-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liong Men Long, MBBS principal investigator
Island Hospital, Penang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic stimulation in people with Stress Urinary Incontinence, run by QRS Asia Sdn Bhd at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01924728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.