NCT01355133

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2011

Enrollment Period

1.5 years

First QC Date

May 12, 2011

Last Update Submit

May 16, 2011

Conditions

Stress Urinary Incontinence

Keywords

Urinary incontinenceMyoblastsMuscle derived cellsStem cells

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in Incontinence episode frequency (IEF)

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

    6 months post-implantation

  • 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

    6 months post-implantation

  • Change from baseline in the Incontinence score

    6 months post-implantation

Secondary Outcomes (6)

  • Time to onset of response

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

  • Change from baseline in Fixed bladder stress test outcome

    Baseline, 6 months postimplantation.

  • Rate for subsequent incontinence surgery

    6 months post-implantation

  • Change from baseline in Urodynamic evaluation

    6 months post-implantation

  • Safety

    Up to 6 months post-implantation

  • +1 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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)
  • 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).
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Ljubljana, Dept. of Gynecology

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 22342057DERIVED

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 17, 2011

Study Start

August 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 17, 2011

Record last verified: 2011-05

Locations

SL(1)