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Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure

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ClinicalTrials.gov Identifier: NCT00984958
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Per-Goran Larsson, Skaraborg Hospital

Brief Summary:
The aim of this prospective, randomized study of Bulkamid treatment is to investigate the efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to TVT-procedure because of suspected ISD.

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Treatment Device: Bulkamid Device: Bulkamid expectation Phase 4

Detailed Description:

The aim of this prospective, randomized study is to investigate the effect of Bulkamid injection for women with urinary stress incontinence and not suitable to TVT-procedure because of suspected ISD and compare this treatment with no or traditional treatment. The primary endpoint for efficacy will be reduction of leakage during pad-test at 2 months compared with pad- test before injection.

Secondary endpoints will be patient satisfaction measured at both 2 and 12 months using a questionnaire and the number of side effects.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure Because of Suspected ISD: A Prospective Randomized Study
Actual Study Start Date : October 2009
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Bulkamid
Injection with Bulkamid
Device: Bulkamid
injection of Bulkamid in the urethra

expectance
The expectance arm will after 2 month have the same treatment as the treatment arm
Device: Bulkamid expectation
expectance
Other Name: after 2 month the patient can be treated




Primary Outcome Measures :
  1. After 2 months a scheduled visit with a new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in. [ Time Frame: 2 month ]

Secondary Outcome Measures :
  1. After 12 months a scheduled visit with new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in. [ Time Frame: 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Ability to understand the information and to give informed consent.

  • At least 50 years of age
  • History of urinary leakage during low grade physical activity. A woman with genuine stress incontinence has urinary incontinence during running or jumping. Women with suspected ISD have incontinence at much lower grade of physical activity such as slow walking or standing up and just coughing. Walking, standing up from a chair, and coughing are regarded as low grade of physical activity.
  • A positive pad-test (after coughing 10 times) with increase of minimum of 10 grams of urine with 300 ml in the bladder or a 24 h pad-test of more than 100 mg of urine
  • No hypermobility of the urethra during cough test.
  • Low pressure of the urethra (optional?)
  • With a of average miction volume of minimum 150 ml and at least one volume of more than 250

Exclusion Criteria:

  • Women with hypermobility of the urethra during coughing and positive Bonney's test
  • Women suitable for a TVT procedure.
  • Positive urinary culture
  • Urge incontinence

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 ClinicalTrials.gov identifier (NCT number): NCT00984958


Locations
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Sweden
Deprtm Ob/Gyn
Skövde, Sweden, SE54185
Sponsors and Collaborators
Skaraborg Hospital
Investigators
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Principal Investigator: P-G Larsson, professor Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden

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Responsible Party: Per-Goran Larsson, professor, Skaraborg Hospital
ClinicalTrials.gov Identifier: NCT00984958     History of Changes
Other Study ID Numbers: Bulkamid ISD2009 04
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms