Surgical Treatment To Greater Anterior Vaginal Prolapse

Hernia Clinical Trial

— 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 .

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00676325
• Other study ID #: unifespcep 1790/06
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 1, 2008
• Last updated: May 12, 2008
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: May 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystocele
• Hernia
• Prolapse

Intervention

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.

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 .

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.

Locations

Country	Name	City	State
Brazil	Sao Paulo Hospital	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is recurrent anterior vaginal prolapse		1 year	Yes
Secondary	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	Yes

External Links

•   INTERNATIONAL UROGYNECOLOGICAL ASSOCIATION