A Phase 4 interventional study of Surgical treatment of Anterior Vaginal Prolapse and NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina. in Hernia and Cystocele, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-05-13.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment
A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.
Seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair( NAZCA TC™ POP REPAIR SYSTEM) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, length of hospitalization, and adverse events.
62 studies on the registry are indexed under Cystocele; 4 are open to participants now.
This study's enrollment of 70 is close to the median of 75 across 42 interventional studies indexed under Cystocele.
Browse Cystocele studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Patients were excluded if they had:
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction were eligible for participation.traditional colporrhaphy in this group.
Procedure: Surgical treatment of Anterior Vaginal Prolapse · Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
The NAZCA TC™ POP REPAIR SYSTEM (polypropylene mesh repair),promedon™ , cordoba, argentina, is used to repair anterior vaginal prolapse by a transobturator and pre pubic approach . Helical needles are used to anchor graft to the pelvic sidewall at two points transobturator, the other two arms pre pubic needles is used. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the procedure with polypropylene mesh with that of anterior colporrhaphy, with planned follow-up of 1 years.
Procedure: Surgical treatment of Anterior Vaginal Prolapse · Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina. · Procedure: surgical treatment for anterior vaginal wall prolapse
seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair (NAZCA TC™ POP REPAIR SYSTEM ) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events.
Also known as: traditional colporraphy anterior vaginal wall, polypropylene mesh - NAZCA TC™ POP REPAIR SYSTEM
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .
Also known as: traditional colporraphy
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation.
Also known as: NAZCA TC™ POP REPAIR SYSTEM
The primary outcome measure is recurrent anterior vaginal prolapse
Time frame: 1 year
Secondary outcomes are, first, operative time (from first incision to closure of last incision), blood loss (preoperative minus postoperative day one hemoglobin), length of hospitalization, adverse events, PQol , FSFI and Dyspareunia .
Time frame: 1 year
This study is status unknown, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo