NCT01924728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

August 14, 2013

Last Update Submit

February 19, 2016

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF)

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

Secondary Outcomes (4)

  • Change in Incontinence Episode Frequency (IEF)

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

  • Change in 1-hour exercise (stress) pad test

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

  • Change in Patient Global Impression of Improvement (PGI-I)

    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)

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

Study Arms (2)

Magnetic stimulation

ACTIVE COMPARATOR

Active magnetic stimulation delivered to the pelvic floor muscles

Device: Magnetic stimulation

Sham magnetic stimulation

SHAM COMPARATOR

Sham magnetic stimulation delivered to the pelvic floor muscles

Device: Sham magnetic stimulation

Interventions

Magnetic stimulationDEVICE

50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles

Magnetic stimulation
Sham magnetic stimulationDEVICE

50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles

Sham magnetic stimulation

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Island Hospital

George Town, Pulau Pinang, 10450, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 26093910DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Liong Men Long, MBBS

    Island Hospital, Penang

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M. Pharm

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 16, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

MY(1)