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CompletedNCT00984958Updated Aug 30, 2019

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

An interventional study of Bulkamid and Bulkamid expectation in Urinary Stress Incontinence and Treatment, sponsored by Skaraborg Hospital. Completed at 1 site in Sweden. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by Skaraborg Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Stress Incontinence
  • Treatment
03

In context

Urinary Incontinence, Stress

658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 509 interventional studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Skaraborg Hospital is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    Bulkamid

    Injection with Bulkamid

    Device: Bulkamid

  • Other
    expectance

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

    Device: Bulkamid expectation

Interventions

  • DeviceBulkamid

    injection of Bulkamid in the urethra

  • DeviceBulkamid expectation

    expectance

    Also known as: after 2 month the patient can be treated

06

What researchers measure

Primary outcomes

  1. 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.

    less intcontines

    Time frame: 2 month

Secondary outcomes

  1. 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.

    less inkontinens

    Time frame: 12 month

07

Study locations

1 site
  • Deprtm Ob/Gyn
    Skövde, SE54185, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00984958
Lead sponsor
Skaraborg Hospital
Responsible party
Per-Goran Larsson (professor, Skaraborg Hospital) — Principal investigator
First posted
Sep 25, 2009
Start date
Oct 2009
Primary completion
Jul 2015
Completion
Dec 2016
Last update
Aug 30, 2019

Study contacts

P-G Larsson, professor
principal investigator · Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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