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Intrasphincteric injections of autologous muscular cells in women with refractory stress urinary incontinence: a prospective study

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Abstract

Introduction and hypothesis

Cell therapy for stress urinary incontinence (SUI) management has been experienced with encouraging results.

Methods

We conducted an open prospective study on 12 women presenting severe SUI with fixed urethra, after previous failed surgical management. Patients underwent intrasphincteric injections of autologous progenitor muscular cells isolated from a biopsy of deltoid muscle. Primary endpoint focused on safety (measurement of Q max variation after 3 months). Secondary endpoints assessed side effects and efficacy.

Results

No variation was diagnosed on Q max measurements. Efficacy data show that three of 12 patients are dry at 12 months, seven other patients are improved on pad test but not on voiding diary, and two patients were slightly worsened by the procedure. Quality of life was improved in half of patients.

Conclusions

Cell therapy for severe multioperated cases of SUI is a mini-invasive, feasible, and safe procedure that can improve urinary condition in as a second line therapy.

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Abbreviations

BMI:

Body mass index

ISD:

Intrinsic sphincter deficiency

PFME:

Pelvic floor muscle exercises

PVR:

Post-voiding residual

Q max :

Maximum urinary flow rate

QoL:

Quality of life

SUI:

Stress urinary incontinence

UI:

Urinary incontinence

UPP:

Urethral pressure profile

UTI:

Urinary tract infection

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Conflicts of interest

Christelle Doucet is employed by Celogos. Christian Pinset is shareholder of Celogos and the inventor and the owner of the patent protecting the process of manufacturing cells. Sixtina Gil Diez de Medina received payment from HRA Pharma, a firm that holds shares in CELOGOS capital.

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Authors and Affiliations

  1. Department of Urology, Tenon Hospital, Groupe Hospitalo-Universitaire EST, Assistance Publique-Hôpitaux de Paris (AP-HP), University Paris VI, 4 rue de la Chine, 75970, Paris Cedex 20, France

    Philippe Sèbe, Jean-Nicolas Cornu, Calin Ciofu, Sixtina Gil Diez de Medina & Francois Haab

  2. CELOGOS, 15 rue Béranger, 75003, Paris, France

    Christelle Doucet

  3. Urology and Andrology Unit, Nîmes Hospital, Place du Pr. Debré, 30029, Nîmes, France

    Pierre Costa

  4. CECS/Istem, Genopole Campus 1, 5 rue Henri Desbruères, Evry, France

    Christian Pinset

Authors
  1. Philippe Sèbe
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  2. Christelle Doucet
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  3. Jean-Nicolas Cornu
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  4. Calin Ciofu
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  5. Pierre Costa
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  6. Sixtina Gil Diez de Medina
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  7. Christian Pinset
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  8. Francois Haab
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Corresponding author

Correspondence to Jean-Nicolas Cornu.

Additional information

Philippe Sèbe and Christelle Doucet have contributed equally to this work.

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Sèbe, P., Doucet, C., Cornu, JN. et al. Intrasphincteric injections of autologous muscular cells in women with refractory stress urinary incontinence: a prospective study. Int Urogynecol J 22, 183–189 (2011). https://doi.org/10.1007/s00192-010-1255-5

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  • DOI: https://doi.org/10.1007/s00192-010-1255-5

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