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

Copenhagen University Hospital at Herlev

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Urinary Incontinence, Stress

Treatments: Procedure: Periurethral injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01323426

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

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stress urinary incontinence refractory to conservative treatment.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

periurethral injection

Experimental group

Description:

Periurethral injection of autologous muscle fibers

Treatment:

Procedure: Periurethral injection