Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196495

Enrollment

Registered

2005-09-20

Start date

2004-06-30

Completion date

2005-11-30

Last updated

2006-12-18

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

Conditions

Vaginal Prolapse

Brief summary

Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.

Interventions

DEVICEPolypropylene Mesh

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse). * Patient who is at leat 21 years of age. * Patient whose family is complete. * Patient may not have uncontrolled diabetes.

Exclusion criteria

* Patients may not have coagulation disorders.

Design outcomes

Primary

Measure	Time frame
Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.	—

Secondary

Measure	Time frame
Intraoperative complication	—
Patient tolerance of the synthetic mesh placed	—
Postoperative complications	—
Quality of life	—

Outcome results

None listed

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