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Surgical Treatment To Greater Anterior Vaginal Prolapse (Nazcatc™)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00676325
First received: May 1, 2008
Last updated: May 12, 2008
Last verified: May 2008
History of Changes

May 1, 2008
May 12, 2008
January 2007
December 2008   (final data collection date for primary outcome measure)
The primary outcome measure is recurrent anterior vaginal prolapse [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00676325 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Surgical Treatment To Greater Anterior Vaginal Prolapse
A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hernia
  • Cystocele
  • Procedure: 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.
    Other Names:
    • traditional colporraphy anterior vaginal wall
    • polypropylene mesh - NAZCA TC™ POP REPAIR SYSTEM
  • Device: 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 .
    Other Name: traditional colporraphy
  • Procedure: 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 Name: NAZCA TC™ POP REPAIR SYSTEM
  • Active Comparator: 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.
    Interventions:
    • Procedure: Surgical treatment of Anterior Vaginal Prolapse
    • Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
  • Active Comparator: 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.
    Interventions:
    • Procedure: Surgical treatment of Anterior Vaginal Prolapse
    • Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
    • Procedure: surgical treatment for anterior vaginal wall prolapse
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 Mar 20; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
70
December 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not,point (Ba)ics96, below hymenal ring requiring surgical correction were eligible for participation.

Exclusion Criteria:

Patients were excluded if they had:

  • 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.
Female
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00676325
unifespcep 1790/06
Yes
carlos antonio del roy, federal university of sao paulo- unifesp
Federal University of São Paulo
Not Provided
Principal Investigator: carlos a del roy, M D federal university of sao paulo
Federal University of São Paulo
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP