Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence

PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 1, 2015

Primary Completion Date

October 30, 2016

Study Completion Date

December 1, 2016

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.

Trial Locations (1)

Unknown

Maternity hospital, Ain Shams University, Cairo

All Listed Sponsors
lead

Ain Shams Maternity Hospital

OTHER

NCT02334878 - Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter