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Clinical Trial
. 2025 Mar;36(3):703-713.
doi: 10.1007/s00192-025-06079-0. Epub 2025 Feb 20.

Implantation of Autologous Skeletal Muscle-Derived Cells Combined with Electrical Stimulation in Patients with Stress Urinary Incontinence

Achim Rose  1 , Herbert Rübben  2
Affiliations
Clinical Trial

Implantation of Autologous Skeletal Muscle-Derived Cells Combined with Electrical Stimulation in Patients with Stress Urinary Incontinence

Achim Rose et al. Int Urogynecol J. 2025 Mar.

Abstract

Introduction and hypothesis: Intrasphincteric injection of autologous skeletal muscle-derived cells (aSMDCs) is a minimally invasive treatment for stress urinary incontinence (SUI). This study investigated two cell counts (high/low dose) for functional urethral sphincter regeneration in combination with electrical stimulation, treatment safety and efficacy, and its potential superiority to duloxetine-placebo or duloxetine.

Methods: This phase II, placebo-controlled trial randomised women with SUI to cell implantation (low or high cell number) and to control groups (duloxetine-placebo or duloxetine), each treatment combined with electrical stimulation. The primary efficacy endpoint was the mean reduction of incontinence episode frequency (IEF) at 12 weeks post-treatment compared with baseline. Secondary efficacy parameters included 1-h pad test, visual analogue scale (VAS), Incontinence Quality of Life questionnaire, clinical global impression score and frequency of responders based on IEF. Adverse events were analysed for safety evaluation. Additional follow-up data on IEF and selected secondary efficacy variables were obtained in a sub-population of patients after 12 and 48 months.

Results: The mean reduction ± SD in IEF after 12 weeks was: low cells: -16.4 ± 13.3 (61 patients), high cells: -18.5 ± 18.7 (56), placebo: -9.7 ± 13.7 (68), duloxetine -11.2 ± 19.6 (32). Cell treatments were significantly superior over placebo regarding IEF reduction and all secondary endpoints except for VAS. No safety issues were observed following cell implantation. Improvements were sustained over 12 and 48 months, with no difference between low and high cell implantation groups.

Conclusions: Therapy for SUI with aSMDCs in combination with electrical stimulation is safe, effective and sustained over at least 48 months.

Keywords: Autologous skeletal muscle-derived cells; Duloxetine; Electrical stimulation; Randomized controlled trial; Stress urinary incontinence.

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Conflict of interest statement

Declarations. Ethics Statement: The study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice Guidelines and the World Medical Association Declaration of Helsinki 1964 and its amendments and subsequent clarifications. Ethical approval was obtained from the Ethics Committee for Multicentre Clinical Trials/Bulgarian Drug Agency (Bulgaria), the Ethik-Kommission der Ärztekammer Nordrhein/Paul-Ehrlich-Institut—Bundesamt für Sera und Impfstoffe (Germany), the Bioethics Committee-Romanian College of Physicians (Bucharest, Timisiora, Cara-Severin, Cluj), National Medicines and Medical Devices Agency (Romania), and the Multicenter Ethics Committee Hospital Brno/State/Institute for Drug Control and the Ethics Committee Hospital Hradec Králové/State/Institute for Drug Control (Czech Republic). Written informed consent was obtained from all patients involved in this trial. Conflicts of Interest: Achim Rose and Herbert Rübben are Consultants for Innovacell Biotechnology AG.

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