Clinical trial NCT01924728: Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: QRS Asia Sdn Bhd
Sponsor class: INDUSTRY
Collaborators: name: Universiti Sains Malaysia
name: Island Hospital
name: Penang Adventist Hospital
First posted: 2013-08-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).

Eligibility 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

Primary outcomes:
measure: Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF)
timeFrame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Secondary outcomes:
measure: Change in Incontinence Episode Frequency (IEF)
timeFrame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
measure: Change in 1-hour exercise (stress) pad test
timeFrame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
measure: Change in Patient Global Impression of Improvement (PGI-I)
timeFrame: Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
measure: Change in International consultation on incontinence questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
timeFrame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Other outcomes:
Locations:
city: Penang
country: Malaysia
facility: Island Hospital
Study officials:
affiliation: Island Hospital, Penang
name: Liong Men Long, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.