Clinical trial NCT00984958: Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Stress Incontinence
Treatment
Lead sponsor: Skaraborg Hospital
Sponsor class: OTHER_GOV
First posted: 2009-09-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 will get treatment and Group 2 will have no treatment for 2 month
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 2 month
Secondary outcomes:
measure: 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.
timeFrame: 12 month
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: Deprtm Ob/Gyn
Study officials:
affiliation: Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden
name: P-G Larsson, professor
role: PRINCIPAL_INVESTIGATOR
References: