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

Treatment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984958
• Other study ID #: Bulkamid ISD2009 04
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Treatment
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

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