An open, multicenter study to evaluate the urodynamic properties of a local implantation of autologous skeletal muscle-derived cells (SMDCs) in female patients with stress urinary incontinence - PD Study

Phase 1

• Conditions: Stress urinary incontinence (SUI) in female patients with predominantly intrinsic sphincter deficiency of moderate severity (Grade 2 and Grade 3); MedDRA version: 14.0Level: PTClassification code 10066218Term: Stress urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2010-021867-34-SI
• Lead Sponsor: Innovacell Biotechnologie AG - Life Science Center Innsbruck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-12
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

1. Patients of =18 to 75 years,
2. Graded as moderate SUI at the screening visit, according to the classification based on the
short pad test of Hahn and Fall (1991) Grade 2 (2 - 10 mL leakage) or Grade 3 (11 -
50 mL leakage),
3. Diagnosed with SUI, predominantly intrinsic sphincter deficiency, confirmed by urodynamic
testing (filling cystometry, urethral pressure profile) at screening.
Patients will only be included in case of:
- missing detrusor overactivity, i.e. involuntary detrusor contraction,
- a cystometric capacity >300 mL,
- compliance of >25 mL/cm H2O,
- post void residual urine <50 mL,
- ability to void urine spontaneously,
- maximum urethral closure pressure <30 cm H2O and/or pressure transmission ratio <75% in
the midurethra,
- fixed urethra (no or low hypermobility),
4. The SUI diagnosis has to be based on the patient’s medical history (including anamnestic
complaints of involuntary leakage on effort or exertion or on sneezing or coughing) and a
positive cough test (fixed volume) at the screening visit,
5. History of inefficient, insufficient, and/or refused PFMT,
6. Patients who have a negative urine test (dipstick) at visit 0,
7. Patients willing and able to comply with the study procedures,
8. Patients who are mentally competent and able to understand all study requirements,
9. Patients must agree to read and sign the Informed Consent (IC) form prior to any study-
related procedures,
10. Female patients of childbearing potential willing to use acceptable methods of
contraception (birth control pills, barriers, or abstinence).
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

1. Pelvic organ prolapse >Stage II (ICS-Classification: The most distal portion of the prolapse is
more than 1 cm below the plane of the hymen, but protrudes no further than two centimeters
less than the total vaginal length in cm) detected during the last 12 months prior to patient
inclusion in the study,
2. Patients who have a medical history of uncontrolled overactive bladder (OAB) or urinary
incontinence other than SUI (including anamnestic complaints on involuntary urine leakage
accompanied by or immediately preceded by urgency, not stress induced),
3. Patients who have undergone a surgery in pelvis minor due to cancer,
4. Patients who have undergone any surgery for SUI, including midurethral slings, Burch
colposuspension, or bulking agents,
5. Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis
HCV, acute viral hepatitis HBV, and/or active Syphilis,
6. Patients diagnosed with any kind of skeletal muscle disease,
7. Patients who, according to the clinical judgment of the investigator, are not suitable for this
study,
8. Patients who are currently participating or have participated in another clinical trial (testing
medical device or drug) within 30 days prior to the study begin or have previously
participated in the current clinical study,
9. Patients who are pregnant, lactating, or intending pregnancy in the near future, and those
of childbearing potential who are not willing to use acceptable methods of contraception
(birth control pills, barriers, or abstinence),
10. Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral
neuropathic pain,
11. Patients with compromised immune systems,
12. Patients complaining about symptoms of acute cystitis or urethritis at visit 0,
13. Patients who had previously undergone radiation of the pelvis,
14. Patients with coagulopathy and/or currently being under treatment with anticoagulant
drugs. However, if the anticoagulant therapy may be changed to heparin treatment prior to
the therapy, the patients can be included into the study,
15. Patients with chronic pelvic pain or complaining about pelvic pain syndrome and/or
dyspareunia,
16. Patients with uncontrolled narrow-angle glaucoma,
17. Patients with severe myocardial disorders or irregular pulse, and those with an artificial
pacemaker,
18. Patients with implantations of metal components in the electrical stimulation treatment
area,
19. Patients dependent from the sponsor, CRO, or the investigator (e.g. employees, relatives,
etc.),
20. Patients with a malignant disease not in remission for 5 years or more,
21. Patients with any persistent chronic bacterial infections as well as local infections as
indicated by a high value of CRP and confirmed by bacteriological analysis,
22. Patients with known hypersensitivity to any component of the product (autologous cells,
ringer’s lactate, human serum albumin, DMSO, bovine proteins, fibroblast growth factor).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified