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 |
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Erscheinungsjahr: |
2022 |
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Erschienen: |
2022 |
Enthalten in: |
Zur Gesamtaufnahme - volume:157 |
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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 |
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Beteiligte Personen: |
Blaganje, Mija [VerfasserIn] |
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Links: |
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Themen: |
Autologous skeletal-muscle derived cells |
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Anmerkungen: |
Date Completed 14.04.2022 Date Revised 14.04.2022 published: Print-Electronic Citation Status MEDLINE |
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doi: |
10.1002/ijgo.13853 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM328996904 |
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520 | |a © 2021 International Federation of Gynecology and Obstetrics. | ||
520 | |a OBJECTIVE: To evaluate improvement of stress urinary incontinence (SUI) and functional status of the urethra after autologous skeletal-muscle derived cell (aSMDC) implantation | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a CLINICAL REGISTRATION: Clinical study was registered under Eudra-CT number: 2010-021867-34 at European Clinical Trial Database (EudraCT), accessible at: EudraCT (europa.eu) | ||
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