Nazcatc™: Surgical Treatment To Greater Anterior Vaginal Prolapse

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00676325

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (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 .

Study Start Date :

Jan 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2008

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: NAZCA TC™ POP REPAIR SYSTEM

Arm

Intervention/Treatment

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 Names:

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

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 Names:

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 Names:

NAZCA TC™ POP REPAIR SYSTEM

Outcome Measures

Primary Outcome Measures

The primary outcome measure is recurrent anterior vaginal prolapse [1 year]

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 . [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.