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

Autologous Muscle Fiber Transplantation for Repair of the Urethral Sphincter in Patients With Stress Urinary Incontinence

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01323426

Enrollment

Registered

2011-03-25

Start date

2010-05-31

Completion date

2013-09-30

Last updated

2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Stress

Keywords

urinary incontinence, stress, autologous

Brief 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.

Interventions

PROCEDUREPeriurethral injection

Periurethral injection of autologous muscle fibers

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stress urinary incontinence refractory to conservative treatment.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of incontinence episodes	12 months	Reduction in the number of leakages in three days

Secondary

Measure	Time frame
International Consultation on Incontinence (ICIQ)short form incontinence score	12 months
Intraurethral pressure measured by reflectometry	12 months
Uroflow	12 months
Adverse events peri- or postoperatively	12 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026