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 .

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00676325

Acronym

Nazcatc™

Enrollment

Registered

2008-05-13

Start date

2007-01-31

Completion date

2009-12-31

Last updated

2008-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystocele, Hernia

Keywords

anterior vaginal prolapse, traditional treatment, mesh, graft, NAZCA TC™ POP REPAIR SYSTEM, colporrhaphy

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.

Interventions

PROCEDURESurgical 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.

DEVICENAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.

Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .

PROCEDUREsurgical 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

50 Years to No maximum

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.

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is recurrent anterior vaginal prolapse	1 year

Secondary

Measure	Time frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026