Surgical Treatment To Greater Anterior Vaginal Prolapse
NCT ID: NCT00676325
Last Updated: 2008-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2007-01-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
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.
Surgical treatment of Anterior Vaginal 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.
NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .
2
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.
Surgical treatment of Anterior Vaginal 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.
NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .
surgical treatment for anterior vaginal wall prolapse
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation.
Interventions
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Surgical treatment of Anterior Vaginal 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.
NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .
surgical treatment for anterior vaginal wall prolapse
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Stage 0 or I (ics96) anterior vaginal support
* Declined participation
* Were pregnant or contemplating future pregnancy
* Had prior anterior vaginal prolapse repair with biologic or synthetic graft
* Active or latent systemic infection
* Compromised immune system
* Uncontrolled diabetes mellitus,
* Previous pelvic irradiation or cancer
* Known hypersensitivity to polypropylene.
50 Years
FEMALE
Yes
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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federal university of sao paulo- unifesp
Principal Investigators
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carlos a del roy, M D
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Sao Paulo Hospital
São Paulo, São Paulo, Brazil
Countries
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References
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Riccetto C, Miyaoka R, de Fraga R, Barbosa R, Dambros M, Teixeira A, Palma P. Impact of the structure of polypropylene meshes in local tissue reaction: in vivo stereological study. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1117-23. doi: 10.1007/s00192-008-0582-2. Epub 2008 Mar 20.
Related Links
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INTERNATIONAL UROGYNECOLOGICAL ASSOCIATION
Other Identifiers
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unifespcep 1790/06
Identifier Type: -
Identifier Source: org_study_id