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

August 28, 2019 updated by: Per-Goran Larsson, Skaraborg Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Skövde, Sweden, SE54185
        • Deprtm Ob/Gyn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bulkamid
Injection with Bulkamid
Device: Bulkamid
injection of Bulkamid in the urethra
Other: expectance
The expectance arm will after 2 month have the same treatment as the treatment arm
Device: Bulkamid expectation
expectance
Other Names:
  • after 2 month the patient can be treated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
less intcontines
2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
less inkontinens
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skaraborg Hospital

Investigators

  • Principal Investigator: P-G Larsson, professor, Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2009

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (Estimate)

September 25, 2009

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bulkamid ISD2009 04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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