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Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence

NCT02334878 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-09-11

No results posted yet for this study

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).

Conditions

  • Urinary Incontinence, Stress

Interventions

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.

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.

Sponsors & Collaborators

  • Ain Shams Maternity Hospital

    lead OTHER

Principal Investigators

  • Mohamed A El-Nazer, PhD · Ain Shams University Maternity Hospital

  • Abdel-Latif G El-Kholy, PhD · Ain Shams University Maternity Hospital

  • Mostafa F Gomaa, PhD · Ain Shams University Maternity Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2016-10-30
Completion
2016-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02334878 on ClinicalTrials.gov