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Surgical Treatment To Greater Anterior Vaginal Prolapse (Nazcatc™)

Primary Purpose

Hernia, Cystocele

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Surgical treatment of Anterior Vaginal Prolapse
NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
surgical treatment for anterior vaginal wall prolapse
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring anterior vaginal prolapse, traditional treatment, mesh, graft, NAZCA TC™ POP REPAIR SYSTEM, colporrhaphy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sao Paulo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The primary outcome measure is recurrent anterior vaginal prolapse

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 .

Full Information

First Posted
May 1, 2008
Last Updated
May 12, 2008
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00676325
Brief Title
Surgical Treatment To Greater Anterior Vaginal Prolapse
Acronym
Nazcatc™
Official Title
A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Cystocele
Keywords
anterior vaginal prolapse, traditional treatment, mesh, graft, NAZCA TC™ POP REPAIR SYSTEM, colporrhaphy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment of Anterior Vaginal Prolapse
Other Intervention Name(s)
traditional colporraphy anterior vaginal wall, polypropylene mesh - NAZCA TC™ POP REPAIR SYSTEM
Intervention 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, blood loss, length of hospitalization, and adverse events.
Intervention Type
Device
Intervention Name(s)
NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
Other Intervention Name(s)
traditional colporraphy
Intervention Description
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .
Intervention Type
Procedure
Intervention Name(s)
surgical treatment for anterior vaginal wall prolapse
Other Intervention Name(s)
NAZCA TC™ POP REPAIR SYSTEM
Intervention Description
Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation.
Primary Outcome Measure Information:
Title
The primary outcome measure is recurrent anterior vaginal prolapse
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
carlos a del roy, M D
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sao Paulo Hospital
City
Sao Paulo
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18351281
Citation
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.
Results Reference
result
Links:
URL
http://www.iuga.org
Description
INTERNATIONAL UROGYNECOLOGICAL ASSOCIATION

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Surgical Treatment To Greater Anterior Vaginal Prolapse

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