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

At older ages there are increased internal anal sphincter thickness and decreased external anal sphincter thickness. Diagnosis of external sphincter atrophy on the basis of sphincter thinning requires that one distinguish between abnormal thinning and age-related differences.

BackgroundIn an earlier pilot study with 10 women, we investigated a new approach for therapy of faecal incontinence (FI) due to obstetric trauma, involving ultrasound-guided injection of autologous skeletal muscle-derived cells (SMDC) into the external anal sphincter (EAS), and observed significant improvement. In the current study, we tested this therapeutic approach in an extended patient group: male and female patients suffering from FI due to EAS damage and/or atrophy. Furthermore, feasibility of lower cell counts and cryo-preserved SMDC was assessed.MethodsIn this single-centre, explorative, baseline-controlled clinical trial, each patient (n = 39; mean age 60.6 ± 13.81 years) received 79.4 ± 22.5 × 106 cryo-preserved autologous SMDC. Changes in FI parameters, Fecal Incontinence Quality of Life (FIQL), anorectal manometry and safety from baseline to 1, 6 and 12 months post implantation were evaluated.ResultsSMDC used in this trial contained a high percentage of myogenic-expressing (CD56+) and muscle stem cell marker-expressing (Pax7+, Myf5+) cells. Intervention was well tolerated without any serious adverse events. After 12 months, the number of weekly incontinence episodes (WIE, primary variable), FIQL and patient condition had improved significantly. In 80.6% of males and 78.4% of females, the WIE frequency decreased by at least 50%; Wexner scores and severity of FI complaints decreased significantly, independent of gender and cause of FI.ConclusionsInjection of SMDCs into the EAS effectively improved sphincter-related FI due to EAS damage and/or atrophy in males and females. When confirmed in a larger, placebo-controlled trial, this minimal invasive procedure has the potential to become first-line therapy for FI.Trial registrationEU Clinical Trials Register, EudraCT 2010-023826-19 (Date of registration: 08.11.2010).

Autologous skeletal-muscle-derived cells to treat obstetric anal incontinence resulted in sustained improvement in incontinence episodes, physiological measurements of anal function and quality of life at 5 years.

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ObjectiveDesign Prospective controlled observational study.Setting District general hospital. PopulationMethods All women were examined using anal endosonography, and parous subjects without apparent sphincter injury compared with age-matched nulliparous controls to determine any differences in general anal canal morphology.Main outcome measures Individual anal canal components were measured at defined levels and subjects compared with controls.Results Twenty-one of 54 parous women had no anal sphincter scar. Compared with nulliparous women, they had significant anterior sphincter thinning (mean 3.7 mm vs 4.6 mm, P c 0.01) in association with lateral external sphincter thickening (mean 7.0 mm vs 4.4 mm, P

Examination in the prone position is preferred. Squeeze maneuvers are of no diagnostic benefit.

The aim of this study is to develop and psychometrically test a questionnaire (Incontinence Outcome Questionnaire, IOQ) for assessing quality of life (QOL) after surgery for stress urinary incontinence that can be used as a single measurement after the intervention. A total of 171 patients who underwent the tension-free vaginal tape (TVT/TVT-O) operation for stress urinary incontinence completed the King s Health Questionnaire (KHQ), the Short Form-12 (SF-12) and the IOQ. The internal consistency, internal and external validity and responsiveness of the IOQ were tested. The IOQ-QOL subscale showed good internal consistency (Cronbach's alpha=0.83) and significant correlations with the KHQ and the SF-12 scales (r=0.30-0.56). Partial correlations with objective parameters showed a significant relation for the IOQ-QOL subscale with objective continence/incontinence. The results of our study suggest that the IOQ is a valid and reliable instrument for assessing QOL after incontinence surgery and can be used if baseline or pre-operative data are unavailable.