AzTrials
AzTrials

Stress Urinary IncontinencePhase 1/2NCT01355133

Safety and Efficacy Study of Intrasphincteric Autologous Myoblast Injection to Treat Stress Urinary Incontinence

A Phase 1/2 study testing Transurethral intrasphincteric autologous myoblast implantation in people with Stress Urinary Incontinence, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this pilot clinical study is to determine if intrasphincteric autologous myoblast injections in combination with electrical stimulation are safe and effective in treating stress urinary incontinence, confirming the optimal dose and assessing tolerability of the procedure. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Stress Urinary Incontinence
What is being tested?
Transurethral intrasphincteric autologous myoblast implantation
Type of treatment
Injection or infusion
How many people
40 participants
Where
1 siteSlovenia
Study dates
Aug 2009to Feb 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female outpatients, predominant clinical diagnosis of SUI
  • Have discrete episodes of incontinence (that is, are dry between episodes and not continuously leaking urine, synchronous with increased intra-abdominal pressure from coughing, sneezing, exercising, etc.)
  • Have a positive Fixed Bladder Volume Cough Stress Test (CST) result; and post void residual volume of <50 ml
  • Report normal urinary diurnal (≤8/day) and nocturnal (≤2/night) frequency per micturition history
  • Have had symptoms of SUI for a minimum of 3 months prior to study entry
  • Can independently use toilet without difficulty
Show all 9Show fewer
  • If patients regularly use laxatives, stool softeners, or stool-bulking agents (for example, fibre supplements), the use of these products should remain constant during participation in the study.
  • Competent to comprehend, sign, and date an Ethics Committee approved informed consent form before any study-specific procedure is performed.
  • Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrolment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device [IUD], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study.

Who cannot join

  • Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:
  • Greater than Stage I Anterior (cystocoele), Apical (uteri), or Posterior (rectocoele) Compartment Prolepses as per the POP-Q)
  • Ureteric bladder, urethral or rectal fistula
  • Uncorrected congenital abnormality leading to urinary incontinence
  • Interstitial cystitis
  • Urinary urgency that results in leakage (as a predominant symptom)
Show all 39Show fewer
  • Adult enuresis
  • Urodynamically proven:
  • detrusor instability
  • sensory urgency defined as first sensation of bladder fill (urge to void) of <100 ml; bladder capacity of <300 ml
  • voiding difficulty
  • Have no sensation at any time during the simple filling cystometry procedure
  • Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment
  • Have a symptomatic urinary tract infection (UTI); or have a history of four or more urinary tract infections in the preceding year.
  • Have prolonged menstruation (>14 days per month).
  • Have history of (or currently have) urogenital cancer.
  • Suffer from severe constipation defined as less than one bowel movement per week
  • Are pregnant, <12 months postpartum or are lactating
  • Have had any major inpatient surgery within 3 months prior to study entry
  • Known infection with human immunodeficiency virus (HIV)
  • Known active infection with Hepatitis B virus, Hepatitis C virus or Lues.
  • Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
  • Have had any anti-incontinence or prolapse surgery, including the following:
  • Anterior Repair
  • Needle Suspension such as Raz; Pereyra; Stamey; Gittes; and Muzsnai procedures
  • Retropubic Procedures: such as Marshall, Marchetti \& Krantz; and Burch procedures
  • Sling Procedure
  • Collagen Injections
  • Artificial Sphincter.
  • Use any of the following:
  • Any anti-incontinence device (for example, Reliance, Minigard, or FemAssist) including tampons used to prevent incontinence during participation in the study
  • Vaginal pessaries for prolapse or incontinence
  • Any nonpharmacologic intervention for incontinence or prolapse (for example, electro stimulation, vaginal cones, or any such device) within the 3 months prior to study entry.
  • Current use of any of the following drugs: antidepressants, duloxetine, monoamine oxidase inhibitors or other, clonidine, alpha-methyl-DOPA, beta-blockers, guanethidine, reserpine, pentosan polysulfate, or alpha-receptor antagonists/agonists (chronic use).
  • Current use of any medications for the treatment of urinary incontinence.
  • Are on a medication regimen including estrogens, anti-estrogens, or diuretics where dose and/or frequency has not been stable for at least the past 12 weeks, or is anticipated to change during the course of the study.
  • ≤ 30 days since receiving an investigational medicinal product or device in another clinical trial. Current enrollment in another clinical trial is not permitted.
  • Allergy/ intolerance of at least one of the active ingredients or excipients of the investigational products, e.g. bovine protein, gentamycin
  • Have any abuse disorder within the 5 years prior to study entry; e.g. patients who report regular consumption of >21 alcoholic drinks per week (an average of 3 drinks per day)

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • University Medical Center Ljubljana, Dept. of Gynecology

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Transurethral Ultrasound-directed Injection of Autologous Myoblasts in Combination With Functional Electrical Stimulation in Patients With Intrinsic Urinary Sphincter Deficiency

The purpose of this pilot clinical study is to determine if intrasphincteric autologous myoblast injections in combination with electrical stimulation are safe and effective in treating stress urinary incontinence, confirming the optimal dose and assessing tolerability of the procedure.

Being tested
Transurethral intrasphincteric autologous myoblast implantation
Keywords
Urinary incontinence, Myoblasts, Muscle derived cells, Stem cells
Medical subject headings
Urinary Incontinence, Stress, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transurethral intrasphincteric autologous myoblast implantationBiological

    Patients undergo upper arm muscle biopsy to isolate and cultivate autologous myoblasts. Using the ultrasound-directed transurethral medical device, 15-18 aliquots (50 - 100 µl per depot) of the 2 ml myoblasts/media suspension are directly injected into the urethral rhabdosphincter at two different levels. The procedure is a single-dose injection of a cell count in range of 1x106 -5x107 cells, depending of the size/quality of the biopsy and quality of outgrowing cells in order to identify possible dose related effects. To possibly enhance cell integration following implantation, a course of transvaginal electrical stimulation is undertaken.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Incontinence episode frequency (IEF)

    The median percent change from baseline in IEF using the 3-day bladder diary analysis

    Measured: 6 months post-implantation

  2. Change from baseline in Quality of Life (I-QOL) total score

    Mean improvement from baseline for the Incontinence Quality of Life (I-QOL) total score

    Measured: 6 months post-implantation

  3. Change from baseline in the Incontinence score

    Measured: 6 months post-implantation

Secondary outcomes (6)

  1. Time to onset of response

    Time to onset of response; time to maximum response; maintenance of response observed through changes in Incontinence episode frequency(IEF), Visual analog scale of the degree of suffering (VAS), Modified patient global impression of improvement(PGI-I*), fixed bladder stress test and I-QOL.

    Measured: Up to 6 months post-implantation (based on recordings at baseline, at implantation, at 6 weeks, 3 months and 6 months post-impalntation)

  2. Change from baseline in Fixed bladder stress test outcome

    Measured: Baseline, 6 months postimplantation.

  3. Rate for subsequent incontinence surgery

    Measured: 6 months post-implantation

  4. Change from baseline in Urodynamic evaluation

    Cystometry, urethral pressure profile (UPP), 1-hour pad-test.

    Measured: 6 months post-implantation

  5. Safety

    Number of adverse events, patholgical lab values, vital signs and weight recordings. Number of immediate and delayed complications of cell injection, including surgical injury, scars, urinary tract infection, inflammation, pelvic pain, prolonged urinary retention, voiding dysfunction, de novo urge incontinence, hematuria, hyperplasia or tumours.

    Any clinically significant findings based on physical examination, standard haematology, clinical chemistry and urinalysis profiles, Electrocardiogram (ECG), Blood Pressure (BP), pulse rate and adverse events recordings.

    Measured: Up to 6 months post-implantation

  6. Change from baseline in Urinary incontinence semiquantitative (UIS)

    Amount of leaked urine measured semiqantitative from a 3-day bladder diary.

    Measured: 6 months post-implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2011 (estimated)
  2. Study startAug 2009
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355133
Sponsor's protocol ID
Myoblast/ISD/EKS01
Other IDs
2009-012389-30, 2009
Status last verified
May 2011
First submitted
12 May 2011
Last updated
17 May 2011
Results posted
No
Data monitoring committee
No

Publications

  • Blaganje M, Lukanovic A. Intrasphincteric autologous myoblast injections with electrical stimulation for stress urinary incontinence. Int J Gynaecol Obstet. 2012 May;117(2):164-7. doi: 10.1016/j.ijgo.2011.11.029. Epub 2012 Feb 18.

    PubMed 22342057

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Transurethral intrasphincteric autologous myoblast implantation in people with Stress Urinary Incontinence, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Incontinence episode frequency (IEF) (time frame: 6 months post-implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01355133, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in