Phase 3
Completed N=143
Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
Urinary Incontinence, Stress
Source: ClinicalTrials.gov NCT01382602 ↗
Enrolled (actual)
143
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months — 82; 90 Percentage of subjects
◆ Published Evidence
Emerging
12citations · ~2 / year
Agreement between simple catheter method and 3D transperineal ultrasound for assessing urethral length measurement before stress urinary incontinence treatment.
Summary
This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).
Linked Publications
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Agreement between simple catheter method and 3D transperineal ultrasound for assessing urethral length measurement before stress urinary incontinence treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months |
82; 90 | — |
Eligibility Criteria
Inclusion Criteria
- Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
Exclusion Criteria
- Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
- Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
- Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
- Patient has not previously attempted conservative treatment for at least 1 month prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
- Patient has more than 2 episode of awakening to void during normal sleeping hours.
- Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to randomization or is likely to change during the course of the study.
- Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
- Patient refuses to provide written informed consent.
- Patient is not at least 18 years of age.
- Patient is not available for the follow-up evaluations as required by the protocol.
Data sourced from ClinicalTrials.gov (NCT01382602) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.