NCT02543242

Brief Summary

The rationale for the conduct of this study is that the Intone device (along with pelvic physiotherapy) can be used to help females suffering from urinary stress incontinence by using electrical stimulation and biofeedback during pelvic floor muscle training. This investigation is important because it can aid in the greater acceptance and development of non-surgical treatments for Stress Urinary Incontinence if these areas are looked into. The study results will address if the Intone device is beneficial and promotes long-term improvement in women that suffer from urinary incontinence.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

September 3, 2015

Last Update Submit

September 4, 2015

Conditions

Urinary Incontinence

Keywords

Urinary IncontinenceStress Urinary IncontinenceUrge IncontinenceMixed Urinary IncontienceFemale Pelvic Health

Outcome Measures

Primary Outcomes (1)

  • Pad Test Weighting

    urine voiding measure

    up to 26 weeks

Secondary Outcomes (6)

  • Urinary Distress Inventory (UDI-6)

    screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.

  • Incontinence Impact Questionnaire Short Form (IIQ-7)

    screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.

  • Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)

    screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.

  • Urinary Incontinence Quality of Life Scale (IQOL)

    screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.

  • International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ UI SF)

    screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.

  • +1 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will undergo the InTone TM (InControl Medical, LLC) medical device treatment for Urinary Incontinence. The frequency of treatment is once/day (12 minutes), 5-6 days/week. The route of administration is vaginal.

Device: InToneTM (InControl Medical, LLC) - Medical Device

Interventions

InToneTM (InControl Medical, LLC) - Medical DeviceDEVICE
Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female gender
  • Between ages 18-70
  • Diagnosed with Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI), or Mixed Urinary Incontinence (MUI)

You may not qualify if:

  • Incontinence of less than 6 months
  • pregnancy or delivery within 6 weeks
  • vaginal or pelvic surgery within previous 6 months
  • pelvic organ prolapse greater than stage 2 (based on POP-Q)
  • active UTI or history of recurrent UTIs (more than 3 in a year)
  • recurrent vaginitis (bacterial/fungal)
  • pelvic pain/painful bladder syndrome
  • implanted cardiac device or untreated cardiac arrhythmi
  • Underlying neurologic/neuromuscular disorder, or inadequate vaginal caliber (can't accommodate device).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network (Altum Health)

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (8)

  • Brubaker L, Benson JT, Bent A, Clark A, Shott S. Transvaginal electrical stimulation for female urinary incontinence. Am J Obstet Gynecol. 1997 Sep;177(3):536-40. doi: 10.1016/s0002-9378(97)70142-x.

    PMID: 9322620BACKGROUND

  • Corcos J, Beaulieu S, Donovan J, Naughton M, Gotoh M; Symptom Quality of Life Assesment Committee of the First International Consultation on Incontinence. Quality of life assessment in men and women with urinary incontinence. J Urol. 2002 Sep;168(3):896-905. doi: 10.1016/S0022-5347(05)64540-5.

    PMID: 12187188BACKGROUND

  • Dumoulin C, Hay-Smith J, Habee-Seguin GM, Mercier J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. Neurourol Urodyn. 2015 Apr;34(4):300-8. doi: 10.1002/nau.22700. Epub 2014 Nov 18.

    PMID: 25408383BACKGROUND

  • Eriksen BC, Bergmann S, Mjolnerod OK. Effect of anal electrostimulation with the 'Incontan' device in women with urinary incontinence. Br J Obstet Gynaecol. 1987 Feb;94(2):147-56. doi: 10.1111/j.1471-0528.1987.tb02342.x.

    PMID: 3493802BACKGROUND

  • Fall M. Does electrostimulation cure urinary incontinence? J Urol. 1984 Apr;131(4):664-7. doi: 10.1016/s0022-5347(17)50566-2.

    PMID: 6608590BACKGROUND

  • Bo K, Talseth T, Holme I. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999 Feb 20;318(7182):487-93. doi: 10.1136/bmj.318.7182.487.

    PMID: 10024253BACKGROUND

  • Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. doi: 10.1016/S0140-6736(06)67925-7.

    PMID: 16399154BACKGROUND

  • Tjelum KB, Lose G, Abel I, Pedersen LM. [Electrostimulation of the pelvic floor muscles in urinary incontinence]. Ugeskr Laeger. 1994 Apr 11;156(15):2214-6. Danish.

    PMID: 8016945BACKGROUND

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, StressUrinary Incontinence, Urge

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dean S Elterman, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean S Elterman, MD

CONTACT

dean.elterman@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 7, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

CA(1)