NCT00247286

Brief Summary

The purpose of this study is to determine the objective (urodynamic) cure rates and effect on patient quality of life after six months of treatment for two different nonsurgical management options for genuine stress urinary incontinence in females: weighted vaginal cones and formal supervised pelvic floor physiotherapy with biofeedback. Hypothesis: Assuming a minimum of six months of treatment, weighted vaginal cones are as effective as a formal supervised program of pelvic floor physiotherapy with biofeedback for the treatment of uncomplicated genuine stress urinary incontinence in females.

Trial Health

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Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

5.3 years

First QC Date

October 31, 2005

Last Update Submit

January 25, 2016

Conditions

Urinary Incontinence, Stress

Keywords

urodynamic stress incontinenceweighted vaginal conespelvic floor biofeedbackrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Urodynamic studies

    6 months

Secondary Outcomes (4)

  • Cough stress test

    6 months

  • Standardized fixed bladder volume pad test

    6 months

  • I-QOL questionnaire

    6 months

  • Urogenital Distress Inventory

    6 months

Study Arms (2)

a

EXPERIMENTAL

Weighted vaginal cones used to perform pelvic floor exercises

Behavioral: weighted vaginal cones

b

ACTIVE COMPARATOR

Biofeedback

Behavioral: Biofeedback

Interventions

weighted vaginal conesBEHAVIORAL
a
BiofeedbackBEHAVIORAL

Pelvic floor muscles exercises performed with a biofeedback machine

b

Eligibility Criteria

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

You may not qualify if:

  • urodynamic identification detrusor instability
  • active (untreated or resistant) urinary tract infection
  • any other disease that is felt by the investigators to potentially interfere with participation (e.g. arthritis limiting dexterity and thus interfering with the insertion and removal of vaginal cones)
  • previous treatment with pelvic floor physiotherapy with biofeedback or functional electric stimulation for urinary incontinence
  • previous use of weighted vaginal cones
  • previous anti-incontinence surgery
  • significant pelvic organ prolapse or those with abnormal vaginal anatomy (the Pelvic Organ Prolapse Quantification (POP-Q) system of scoring for prolapse will be used, Grade \> III)
  • use of concomitant treatments during the trial or the start of new medications that may alter continence mechanism
  • inability to understand instructions in French or English or provide informed consent (e.g., psychiatric disease).
  • pregnancy (which may alter pelvic anatomy may over the course of the study and thus make evaluation of treatment methods impossible)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital, Queen's University

Kingston, Ontario, K7L 4P8, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Biofeedback, Psychology

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

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Marie-Andree Harvey, MD MSc

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

September 1, 2001

Primary Completion

January 1, 2007

Study Completion

October 1, 2007

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

CA(1)