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

Copenhagen University Hospital at Herlev40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Incontinence, Stress

Interventions

Periurethral injectionPROCEDURE

Periurethral injection of autologous muscle fibers

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stress urinary incontinence refractory to conservative treatment. Exclusion Criteria: * urge urinary incontinence * Pregnancy * Pelvic organ prolapse \> grade 1

Locations (1)

Herlev Hospital

Herlev, Denmark

Outcomes

Primary Outcomes

Frequency of incontinence episodes

Reduction in the number of leakages in three days

Time frame: 12 months

Secondary Outcomes

International Consultation on Incontinence (ICIQ)short form incontinence score

Time frame: 12 months

Intraurethral pressure measured by reflectometry

Time frame: 12 months

Uroflow

Time frame: 12 months

Adverse events peri- or postoperatively

Time frame: 12 months

Data from ClinicalTrials.gov

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