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Trial record 84 of 132 for:    autologous mesenchymal stem cells | Completed Studies

Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT02334878
Recruitment Status : Completed
First Posted : January 8, 2015
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Rania Hassan Mostafa, Ain Shams Maternity Hospital

Brief Summary:
This study evaluates the effectiveness of mesenchymal stem cells in treatment of stress urinary incontinence due to intrinsic sphincter deficiency; in which the problem is weakness or damage of the sphincter muscle responsible for continence. Mesenchymal stem cells are undifferentiated cells which can undergo self-renewal & differentiation into other cell types like muscle cells; thus can be used to regenerate the damaged sphincter muscles. In this study mesenchymal stem cells will be obtained from bone marrow from the patient, processed, & then re-injected periurethrally. Effectiveness will be compared to that of the surgical treatment (tension-free vaginal tape).

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Biological: Stem Cells,Mesenchymal Procedure: surgery (TVT) Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow-derived Mesenchymal Stem Cells Versus Tension-free Vaginal Tape for Treatment of Female Stress Urinary Incontinence: An Open-label Clinical Trial
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : October 30, 2016
Actual Study Completion Date : December 1, 2016

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Arm Intervention/treatment
Experimental: Stem cells,Mesenchymal
Periurethral injection of autologous bone-marrow derived stem cells.
Biological: Stem Cells,Mesenchymal
The patient will be placed in lithotomy position. A Foley's catheter (size 18) will be inserted in the urethra, then under local anaesthesia; retrieved cells (total 20- 30 million cells per patient in 10cc syringe) will be injected into the submucosal tissue at the level of the proximal urethra just distal to the bladder neck (guided by stretch on the Foley's catheter), at 3,9,12 o'clock, injecting around 3.5 cc in each site.

Active Comparator: surgery (TVT)
Tension-free vaginal tape operation: a midurethral sling operation
Procedure: surgery (TVT)
A small midurethral incision will be made in the vaginal mucosa, then a polypropylene 40*1cm mesh tape attached to two curved trocars will be passed lateral to the urethra & through the endopelvic fascia into the retropubic space. The trocar will then be passed along the back of the pubic bone, through the rectus fascia, in two small suprapubic skin incisions, then the tension on the tape adjusted & the remaining tape cut off at the level of the skin.




Primary Outcome Measures :
  1. change in cough test & urodynamic study as a measure of efficacy of treatment [ Time Frame: before & after therapy each 3 months for one year (at 3m, 6m, 9m, 12m post-injection). ]
    cough test: as positive or negative leakage with cough. Urodynamic study: changes in abdominal leak point pressure, and changes in maximum urethral closure pressure


Secondary Outcome Measures :
  1. Quality of life as measured by the Incontinence Quality of Life (I-QOL) Instrument Score [ Time Frame: before & after therapy each 3 months for one year (at 3m, 6m, 9m, 12m post-injection). ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of stress urinary incontinence
  • Urodynamic study showing stress urinary incontinence due to intrinsic sphincter deficiency

Exclusion Criteria:

  • Pregnant females
  • Hypermobility of the urethra
  • Mild cases (treatment is mainly physiotherapy & pelvic floor exercises)
  • Urge incontinence / Urodynamic study showing detrusor instability
  • Current urinary infection
  • Current severe cystocele or rectocele
  • History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra
  • Voiding dysfunction (post-void residual volume >100cc)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334878


Locations
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Egypt
Maternity hospital, Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Study Chair: Mohamed A El-Nazer, PhD Ain Shams University Maternity Hospital
Study Director: Abdel-Latif G El-Kholy, PhD Ain Shams University Maternity Hospital
Study Director: Mostafa F Gomaa, PhD Ain Shams University Maternity Hospital

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Responsible Party: Rania Hassan Mostafa, assistant lecturer, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02334878     History of Changes
Other Study ID Numbers: FMASU 3098/2014
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rania Hassan Mostafa, Ain Shams Maternity Hospital:
Stem Cells
Mesenchymal

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders