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Muscle Derived Cell Injection to Treat Anal Incontinence due to Obstetric Trauma: Pilot Study with One-Year Follow-Up.
  1. Andrea Frudinger1,
  2. Dieter Kölle2,
  3. Wolfgang Schwaiger3,
  4. Johann Pfeifer1,
  5. Johannes Paede4,
  6. Steve Halligan5,*
  1. 1 University of Graz, Austria;
  2. 2 District Hospital Schwaz, Austria;
  3. 3 Innovacell Biotechnology, Austria;
  4. 4 B-K Medical, Austria;
  5. 5 University College London, Germany
  1. Correspondence to: Steve Halligan, Specialist Radiology, University College Hospital, Specialist Radiology, Podium level 2,, UCH, 235 Euston Road, London, NW12BU, United Kingdom; s.halligan{at}ucl.ac.uk

Abstract

Objective: To treat anal incontinence due to obstetric external anal sphincter disruption via injection of autologous myoblast cells.

Design: Observational pilot study.

Setting: University hospital and District hospital

Patients: 10 women suffering from anal incontinence due to obstetric anal sphincter injury, refractory to conventional non-surgical therapy.

Interventions: Autologous myoblasts were cultured from a pectoralis muscle biopsy, harvested, and injected into the external anal sphincter defect using direct ultrasound guidance.

Main outcome measures: Wexner incontinence score, anal squeeze pressures, and quality of life 12-months after injection. Safety and technical feasibility.

Results: The procedure was well tolerated and no adverse events were observed. At 12-months the Wexner incontince score had decreased by a mean of 13.7 units (95%CI -16.3 to -11.2), anal squeeze pressures were unchanged, and overall quality of life scores improved by a median of 30 points (95%CI 25 to 42). Anal squeeze pressures did rise significantly at 1-month and 6-months post injection (p=0.03).

Conclusions: Injection of autologous myoblasts is safe, well tolerated, and significantly improves symptoms of anal incontinence due to obstetric anal sphincter trauma.

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