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Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247286
Recruitment Status : Terminated (slow recruitment)
First Posted : November 1, 2005
Last Update Posted : January 27, 2016
Information provided by (Responsible Party):
Dr. Marie-Andree Harvey, Queen's University

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Behavioral: weighted vaginal cones Behavioral: Biofeedback Phase 4

Detailed Description:

Background and Rationale Urinary incontinence is a widespread and debilitating medical problem, with an estimated prevalence of between 17-45% in adult women. Genuine stress incontinence is the most common form of urinary incontinence in women, with objective diagnosis made via urodynamics. Urinary continence is maintained when the urethral resistance (pressure) is greater than the intravesical pressure. Genuine stress incontinence occurs when pressure transmission to the urethra is compromised by poor anatomic support of the proximal urethra resulting from weakened pelvic floor musculature and/or defective endopelvic fascia. While the gold standard for treatment of genuine stress incontinence is still considered to be surgical, there is renewed interest among both patients and surgeons for nonsurgical (conservative) management. The goal of conservative therapy is to restrengthen and retrain the pelvic floor muscles to improve urethral pressure transmission and thus improve the continence mechanism.

Nonsurgical therapies include PFME with or without biofeedback, and weighted vaginal cones. PFME with biofeedback are widely accepted as an effective conservative treatment for genuine stress incontinence, with subjective cure rates estimated to be as high as 70 percent. However, to date, objective cure rates as defined by urodynamics have not been well documented. Similarly, while limited studies suggest that vaginal cone therapy results in a subjective cure rate of 60%, objective cure rates still have not been determined. With growing clinic and surgical waiting lists and rising hospital costs, weighted vaginal cones, if objectively proven to be a comparably effective alternative to physiotherapy, will offer an effective management option for stress incontinence, thus, perhaps avoiding referral to a tertiary hospital for physiotherapy, and surgery.

We hypothesize that following a minimum of six months of treatment, weighted vaginal cones would be as effective as a formal supervised program of pelvic floor physiotherapy with biofeedback for the treatment of uncomplicated genuine stress urinary incontinence in females. We are thus seeking to evaluate the feasibility of a randomized clinical trial.


An estimated 60 women identified from ambulatory clinics with multichannel urodynamics documenting genuine stress urinary incontinence will be needed to participate in this single-blind, randomized pilot study. Once entered, patients will be randomized to receive one of two different nonsurgical treatments: PFME with biofeedback or weighted vaginal cones. The patients will chart compliance to treatment for the duration of the study. A quality of life questionnaire will be completed at the beginning and end of the trial, along with a subjective assessment of incontinence severity via a standardized questionnaire. The study period will be six months. Upon completion of the study, patients will undergo repeat multichannel urodynamics and perineal pad testing to determine if genuine stress incontinence is present or absent and thus whether objective cure has been achieved. Results will be analyzed and compared statistically.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Single-Blind Comparison of Pelvic Floor Muscle Exercises With Biofeedback Versus Weighted Vaginal Cones in the Management of Genuine Stress Incontinence : A Pilot Study
Study Start Date : September 2001
Actual Primary Completion Date : January 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: a
Weighted vaginal cones used to perform pelvic floor exercises
Behavioral: weighted vaginal cones
Active Comparator: b
Behavioral: Biofeedback
Pelvic floor muscles exercises performed with a biofeedback machine

Primary Outcome Measures :
  1. Urodynamic studies [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Cough stress test [ Time Frame: 6 months ]
  2. Standardized fixed bladder volume pad test [ Time Frame: 6 months ]
  3. I-QOL questionnaire [ Time Frame: 6 months ]
  4. Urogenital Distress Inventory [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Females, between the ages of 18-65 years, will be entered into this study. Additional inclusion criteria are a history of urinary stress incontinence and multichannel cystometry confirming the presence of genuine stress incontinence (GSI).

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247286

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Canada, Ontario
Kingston General Hospital, Queen's University
Kingston, Ontario, Canada, K7L 4P8
Sponsors and Collaborators
Queen's University
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Principal Investigator: Marie-Andree Harvey, MD MSc Queen's University

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Responsible Party: Dr. Marie-Andree Harvey, Principal Investigator, Queen's University Identifier: NCT00247286    
Other Study ID Numbers: OBGY-076-00
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dr. Marie-Andree Harvey, Queen's University:
urodynamic stress incontinence
weighted vaginal cones
pelvic floor biofeedback
randomized controlled trial
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Body Weight
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms