Skeletal muscle-derived cell implantation in female patients with stress urinary incontinence: a multinational and multicenter open follow-up study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016597-32-DE

Enrollment

550

Registered

2009-11-05

Start date

2010-04-19

Completion date

Unknown

Last updated

2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress urinary incontinence (SUI) in female patients with predominantly intrinsic sphincter deficiency of moderate severity (Grade 2 and Grade 3). MedDRA version: 12.0 Level: LLT Classification code 10066218 Term: Stress urinary incontinence

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Female patients will only be included in the study if they meet all of the following criteria: • Patients who participated in the phase IIb (SUITE study), phase III, or PD study, • Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients will not be included in the study if any of the following criteria applies: • Participation in another clinical study at the time of being included in this study, • Evidence of uncooperative attitude, • Patients who, according to the clinical judgment of the investigator, are not suitable for this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to show the long term efficacy and safety of the SMDC therapy in the treatment of female patients suffering from SUI.;Secondary Objective: Efficacy variables • IEF score, • Trends in the IEF score, • I-QoL score, • Short pad-test results, • VAS score, • Examinations based on the micturition diary records, • Investigator’s assessment by CGI score, • Patient’s assessment by PGI scores. Safety variables • Adverse events, • Safety laboratory measurements, vital signs, physical examinations.;Primary end point(s): The primary endpoint of this study is the relapse of response regarding the IEF (Incontinence Episodes Frequency) score.	—

Measure

Time frame

Main Objective: The objective of this study is to show the long term efficacy and safety of the SMDC therapy in the treatment of female patients suffering from SUI.;Secondary Objective: Efficacy variables • IEF score, • Trends in the IEF score, • I-QoL score, • Short pad-test results, • VAS score, • Examinations based on the micturition diary records, • Investigator’s assessment by CGI score, • Patient’s assessment by PGI scores. Safety variables • Adverse events, • Safety laboratory measurements, vital signs, physical examinations.;Primary end point(s): The primary endpoint of this study is the relapse of response regarding the IEF (Incontinence Episodes Frequency) score.

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Countries

Bulgaria, Czech Republic, Germany, Poland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026