The effect of skeletal muscle-derived cells implantation on stress urinary incontinence and functional urethral properties in female patients

© 2021 International Federation of Gynecology and Obstetrics..

OBJECTIVE: To evaluate improvement of stress urinary incontinence (SUI) and functional status of the urethra after autologous skeletal-muscle derived cell (aSMDC) implantation.

METHODS: Phase I-II, open, non-randomized, single-center study of ultrasound guided aSMDC implantation (dosed at 0.2 × 106  cells/2 mL) into the external urethral sphincter to treat SUI.

RESULTS: A total of 38 patients were treated and followed for 2 years. SUI measured by Incontinence Episode Frequency score, short pad test, quality of life, patient's and clinician's perception significantly improved and remained improved after 2 years. However, urodynamic urethral properties in general did not improve at 1-year after treatment. Subgroup analysis revealed that addition of an adjuvant functional electrical stimulation therapy discontinued 4 weeks after injection in the compliant group, gave better urodynamic values and maintained the long-term SUI improvement at 2 years.

CONCLUSION: The aSMDC injection was safe and well-tolerated by patients. The status of SUI improved and with it the quality of life of patients, even if this was not necessarily reflected in the urodynamic urethral properties. Electrical stimulation, as an adjuvant therapy, could have an essential role in the success of the therapy.

CLINICAL REGISTRATION: Clinical study was registered under Eudra-CT number: 2010-021867-34 at European Clinical Trial Database (EudraCT), accessible at: EudraCT (europa.eu).

Medienart:

E-Artikel

Erscheinungsjahr:

2022

Erschienen:

2022

Enthalten in:

Zur Gesamtaufnahme - volume:157

Enthalten in:

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics - 157(2022), 2 vom: 06. Mai, Seite 444-451

Sprache:

Englisch

Beteiligte Personen:

Blaganje, Mija [VerfasserIn]
Lukanović, Adolf [VerfasserIn]

Links:

Volltext

Themen:

Autologous skeletal-muscle derived cells
Cell therapy
Journal Article
Myoblasts
Stress urinary incontinence

Anmerkungen:

Date Completed 14.04.2022

Date Revised 14.04.2022

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1002/ijgo.13853

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM328996904