Surgical Treatment To Greater Anterior Vaginal Prolapse

NCT00676325 | Unknown Phase 4 DMC

• 1 other identifier: unifespcep 1790/06
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hernia; Cystocele

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is recurrent anterior vaginal prolapse

  1 year

Secondary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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; Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.

2

ACTIVE COMPARATOR

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; Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.; Procedure: surgical treatment for anterior vaginal wall prolapse

Interventions

Surgical treatment of Anterior Vaginal Prolapse PROCEDURE

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.

Also known as: traditional colporraphy anterior vaginal wall, polypropylene mesh - NAZCA TC™ POP REPAIR SYSTEM

1; 2

NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina. DEVICE

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

Also known as: traditional colporraphy

1; 2

surgical treatment for anterior vaginal wall prolapse PROCEDURE

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

Also known as: NAZCA TC™ POP REPAIR SYSTEM

2

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Sao Paulo Hospital

São Paulo, São Paulo, 04024-002, Brazil

Location

Related 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: 10.1007/s00192-008-0582-2. Epub 2008 Mar 20.

  PMID: 18351281 RESULT

Related Links

• INTERNATIONAL UROGYNECOLOGICAL ASSOCIATION

MeSH Terms

Conditions

Hernia; Cystocele

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Organ Prolapse; Prolapse

Study Officials

• carlos a del roy, M D

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 13, 2008
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: May 13, 2008

Record last verified: 2008-05

Locations

BR (1)