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

Sponsor
Skaraborg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00984958
Collaborator
(none)
50
1
2
86
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Study Details

Study Description

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
  • Device: Bulkamid
  • Device: Bulkamid expectation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group 1 will get treatment and Group 2 will have no treatment for 2 monthGroup 1 will get treatment and Group 2 will have no treatment for 2 month
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Oct 1, 2009
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Bulkamid

Injection with Bulkamid

Device: Bulkamid
injection of Bulkamid in the urethra

Other: expectance

The expectance arm will after 2 month have the same treatment as the treatment arm

Device: Bulkamid expectation
expectance
Other Names:
  • after 2 month the patient can be treated
  • Outcome Measures

    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. [2 month]

      less intcontines

    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. [12 month]

      less inkontinens

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Deprtm Ob/Gyn Skövde Sweden SE54185

    Sponsors and Collaborators

    • Skaraborg Hospital

    Investigators

    • Principal Investigator: P-G Larsson, professor, Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Per-Goran Larsson, professor, Skaraborg Hospital
    ClinicalTrials.gov Identifier:
    NCT00984958
    Other Study ID Numbers:
    • Bulkamid ISD2009 04
    First Posted:
    Sep 25, 2009
    Last Update Posted:
    Aug 30, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 30, 2019