CClinicalTrials.gg
Sign In
Status unknownNCT01323426Updated Jan 24, 2013

Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.

A Phase 1/2 interventional study of Periurethral injection in Urinary Incontinence, Stress, sponsored by Copenhagen University Hospital at Herlev. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-24.

Sponsored by Copenhagen University Hospital at Herlev · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This pilot study examines safety and efficacy of a simple procedure for treatment of stress urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the urethral sphincter.

02

Conditions studied

  • Urinary Incontinence, Stress

Keywords

  • urinary incontinence, stress
  • autologous
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 40 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Copenhagen University Hospital at Herlev is the lead sponsor of 76 studies on the registry; 10 are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • Stress urinary incontinence refractory to conservative treatment.

Exclusion criteria

Exclusion Criteria:

  • urge urinary incontinence
  • Pregnancy
  • Pelvic organ prolapse > grade 1
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    periurethral injection

    Periurethral injection of autologous muscle fibers

    Procedure: Periurethral injection

Interventions

  • ProcedurePeriurethral injection

    Periurethral injection of autologous muscle fibers

06

What researchers measure

Primary outcomes

  1. Frequency of incontinence episodes

    Reduction in the number of leakages in three days

    Time frame: 12 months

Secondary outcomes

  1. International Consultation on Incontinence (ICIQ)short form incontinence score

    Time frame: 12 months

  2. Intraurethral pressure measured by reflectometry

    Time frame: 12 months

  3. Uroflow

    Time frame: 12 months

  4. Adverse events peri- or postoperatively

    Time frame: 12 months

07

Study locations

1 site
  • Herlev Hospital
    Herlev, 2730, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01323426
Lead sponsor
Copenhagen University Hospital at Herlev
Responsible party
Sponsor
First posted
Mar 25, 2011
Start date
May 2010
Primary completion
Sep 2013 (estimated)
Completion
Sep 2013 (estimated)
Last update
Jan 24, 2013

Study contacts

Søren Gräs, MD
principal investigator · Herlev Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urinary Incontinence→

Other studies from this sponsor

Copenhagen University Hospital at Herlev

Start the discussion