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
  Purpose

A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.


Condition Intervention Phase
Hernia
Cystocele
Procedure: Surgical treatment of Anterior Vaginal Prolapse
Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
Procedure: surgical treatment for anterior vaginal wall prolapse
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • The primary outcome measure is recurrent anterior vaginal prolapse [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676325

Locations
Brazil
Sao Paulo Hospital
Sao Paulo, Brazil, 04024-002
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: carlos a del roy, M D federal university of sao paulo
  More Information

Additional Information:
Publications:
Responsible Party: carlos antonio del roy, federal university of sao paulo- unifesp
ClinicalTrials.gov Identifier: NCT00676325     History of Changes
Other Study ID Numbers: unifespcep 1790/06
Study First Received: May 1, 2008
Last Updated: May 12, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
anterior vaginal prolapse
traditional treatment
mesh, graft
NAZCA TC™ POP REPAIR SYSTEM
colporrhaphy

Additional relevant MeSH terms:
Cystocele
Hernia
Prolapse
Uterine Prolapse
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014