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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Skaraborg Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Skaraborg Hospital
ClinicalTrials.gov Identifier:
NCT00984958
First received: September 24, 2009
Last updated: March 3, 2010
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Urinary Stress Incontinence
Treatment
 Device: Bulkamid
Device: Bulkamid expectation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Skaraborg Hospital:

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. [ Time Frame: 2 month ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bulkamid
Injection with Bulkamid
 Device: Bulkamid
injection of Bulkamid in the urethra
Other Name: Bulkamid
expectance
The expectance arm will after 2 month have the same treatment as the treatment arm
 Device: Bulkamid expectation
expectance
Other Name: after 2 month the patient can be treated

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984958

Contacts
Contact: P-G B Larsson, professor +46500431445 p-g.larsson@vgregion.se

Locations
Sweden
Deprtm Ob/Gyn Östra Sjukhuset Sahlgrenska Recruiting
Göteborg, Sweden, 41685
Contact: Corinne Pedroletti            
Principal Investigator: Corinne Pedroletti, Dr            
Deprtm Ob/Gyn universitetsjukhuset Recruiting
Linköping, Sweden, 58185
Contact: Eva Fornell, Dr            
Principal Investigator: Eva Fornell, Dr            
Deprtm Ob/Gyn Recruiting
Skövde, Sweden, SE54185
Contact: P-G Larsson, professor     +46500431445     p-g.larsson@vgregion.se    
Principal Investigator: P-G Larsson, Dr            
Deprtm Ob/Gyn Södersjukhuset Recruiting
Stockholm, Sweden, 11883
Contact: Gunilla Tegerstedt, Dr            
Principal Investigator: Gunilla Tegerstedt, Dr            
Deprtm Ob/Gyn, NU sjukvården Recruiting
Trollhättan, Sweden, 46185
Contact: Ingegred Olsson, Dr            
Principal Investigator: Ingegerd Olssson, Dr            
Deprtm Ob/Gyn Recruiting
Västerås, Sweden, 72189
Contact: Gregor Larsson, Dr            
Principal Investigator: Gergor Larsson, Dr            
Sponsors and Collaborators
Skaraborg Hospital
Investigators
Principal Investigator: P-G Larsson, professor Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden
  More Information

No publications provided

Responsible Party: Professor P-G Larsson, departm Ob/Gyn
ClinicalTrials.gov Identifier: NCT00984958     History of Changes
Other Study ID Numbers: Bulkamid ISD2009 04
Study First Received: September 24, 2009
Last Updated: March 3, 2010
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013