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

Skaraborg Hospital

Status: Completed

Conditions: Treatment; Urinary Stress Incontinence

Treatments: Device: Bulkamid expectation; Device: Bulkamid

Study type: Interventional

Funder types: Other

Identifiers

NCT00984958

Bulkamid ISD2009 04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Bulkamid

Other group

Description:

Injection with Bulkamid

Treatment:

Device: Bulkamid

expectance

Other group

Description:

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

Treatment:

Device: Bulkamid expectation