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

NCT ID: NCT01323426

Last Updated: 2013-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Incontinence, Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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periurethral injection

Periurethral injection of autologous muscle fibers

Group Type EXPERIMENTAL

Periurethral injection

Intervention Type PROCEDURE

Periurethral injection of autologous muscle fibers

Interventions

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Periurethral injection

Periurethral injection of autologous muscle fibers

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Stress urinary incontinence refractory to conservative treatment.

Exclusion Criteria

* urge urinary incontinence
* Pregnancy
* Pelvic organ prolapse \> grade 1
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Søren Gräs, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-1-2009-079 and H-1-2011-032

Identifier Type: -

Identifier Source: org_study_id

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