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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00984958
Other study ID # Bulkamid ISD2009 04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date December 2016

Study information

Verified date August 2019
Source Skaraborg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2016
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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

Study Design


Intervention

Device:
Bulkamid
injection of Bulkamid in the urethra
Bulkamid expectation
expectance

Locations

Country Name City State
Sweden Deprtm Ob/Gyn Skövde

Sponsors (1)

Lead Sponsor Collaborator
Skaraborg Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. less intcontines 2 month
Secondary 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. less inkontinens 12 month
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