Surgical Treatment To Greater Anterior Vaginal Prolapse - Full Text View

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00676325

Purpose

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

Condition	Intervention	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 IV

MedlinePlus related topics: Bladder Diseases Hernia Pelvic Support Problems Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

The primary outcome measure is recurrent anterior vaginal prolapse [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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 . [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	70
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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 .
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 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.

Arms

Assigned Interventions

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

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 .

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

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.

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676325

Locations

Brazil
Sao Paulo Hospital
sao paulo, Brazil, 04024-002

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:

carlos a del roy, M D

federal university of sao paulo

More Information

Additional Information:

INTERNATIONAL UROGYNECOLOGICAL ASSOCIATION This link exits the ClinicalTrials.gov site

Publications of Results:

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 Mar 20; [Epub ahead of print]

Responsible Party:	federal university of sao paulo- unifesp ( carlos antonio del roy )
Study ID Numbers:	unifespcep 1790/06
Study First Received:	May 1, 2008
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00676325
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:

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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Cystocele
Uterine Prolapse
Gastrointestinal Diseases
Urinary Bladder Diseases
Uterine Diseases
Intestinal Diseases

Prolapse
Rectal Diseases
Genital Diseases, Female
Digestive System Diseases
Urologic Diseases
Hernia
Rectal Prolapse

ClinicalTrials.gov processed this record on February 12, 2009