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

NCT ID: NCT00984958

Last Updated: 2019-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Urinary Stress Incontinence; Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bulkamid

Injection with Bulkamid

Group Type: OTHER

Bulkamid

Intervention Type: DEVICE

injection of Bulkamid in the urethra

expectance

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

Group Type: OTHER

Bulkamid expectation

Intervention Type: DEVICE

expectance

Interventions

Bulkamid

injection of Bulkamid in the urethra

Intervention Type: DEVICE

Bulkamid expectation

expectance

Intervention Type: DEVICE

Other Intervention Names

after 2 month the patient can be treated

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Skaraborg Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Per-Goran Larsson

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

P-G Larsson, professor

Role: PRINCIPAL_INVESTIGATOR

Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden

Locations

Deprtm Ob/Gyn

Skövde, , Sweden

Countries

Sweden

Other Identifiers

Bulkamid ISD2009 04

Identifier Type: -

Identifier Source: org_study_id