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

Primary Purpose

Urinary Stress Incontinence, Treatment

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Bulkamid

Bulkamid expectation

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Deprtm Ob/Gyn

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Bulkamid

expectance

Arm Description

Injection with Bulkamid

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

Outcomes

Primary Outcome Measures

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.

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Secondary Outcome Measures

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.

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Full Information

NCT ID

NCT00984958

First Posted

September 24, 2009

Last Updated

August 28, 2019

Sponsor

Skaraborg Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00984958

Brief Title

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

October 2009 (Actual)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Skaraborg Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Stress Incontinence, Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Group 1 will get treatment and Group 2 will have no treatment for 2 month

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bulkamid

Arm Type

Other

Arm Description

Injection with Bulkamid

Arm Title

expectance

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Bulkamid

Intervention Description

injection of Bulkamid in the urethra

Intervention Type

Device

Intervention Name(s)

Bulkamid expectation

Other Intervention Name(s)

after 2 month the patient can be treated

Intervention Description

expectance

Primary Outcome Measure Information:

Title

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.

Description

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Time Frame

2 month

Secondary Outcome Measure Information:

Title

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.

Description

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Time Frame

12 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

P-G Larsson, professor

Organizational Affiliation

Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Deprtm Ob/Gyn

City

Skövde

ZIP/Postal Code

SE54185

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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