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Study To Assess Whether Polypropylene Mesh In Surgery For Cystocele Is Safe And Has Favorable Outcome

Efficacy And Safety Study With Polipropilene Mesh (Nazca Tc) For The Treatment Of Anterior Vaginal Wall Prolapse

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7m2xdy
Enrollment
Unknown
Registered
2013-09-19
Start date
2010-01-10
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Pelvic Organ Prolapse, Related Complications To The Use Of Polypropylene Mesh in Vaginal Surgeries, Urinary Incontinence, Lower urinary tract symptoms

Interventions

From sample size calculation, 122 women aged 45 to 90 years were divided into two groups from simple randomization, where, from the sample calculation and objective of the study, there should be at le
intervention group: 42 women underwent surgical procedures using polypropylene mesh (Nazca Tc). Women in both groups were evaluated 12 and 24 months after the surgery to detect possible anatomical rec
Device
Biological/vaccine
Procedure/surgery
E04.806
E04.680
H02.403.810.300
E04.030

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
45 Years to 90 Years

Inclusion criteria

Inclusion criteria: Not pregnant women; signs and symptoms of genital prolapse; no acute urinary or vaginal infection; no malignant disease; sign in the informed consent

Exclusion criteria

Exclusion criteria: previous surgery for pelvic organ prolapse with polipropylene mesh interposition; mentally disable; ot sign on the informed consent

Design outcomes

Primary

MeasureTime frame
Best anatomical results of anterior vaginal wall prolapse of the patients in the intervention group compared with the control group 12 and 24 months after surgery, analyzed by the method Pelvic Organ Prolapse Quantification System (POP-Q). It is expected anatomic failure at 12 months follow-up of 38% for the control group and 12% for the intervention group. To detect this difference (two-sided test), with significance level of 0.05 and a test power of 80%, 42 women should be allocated at least in each group.—

Secondary

MeasureTime frame
Resolution rate of lower urinary tract symptoms (urinary incontinence, voiding difficulty, urgency and urge incontinence) at least similar between the intervention and control groups 12 and 24 months after surgery, assessed by means of questionnaires International Consultation on incontinence Questionnaire Urinary incontinence Short Form (ICIQ-UI SF) and Overactive Bladder Questionnaire (OAB-V8), both validated for the Portuguese language.—

Countries

Brazil

Contacts

Public ContactPaulo Feldner

Universidade Federal de São Paulo

pfeldner@terra.com.brTel./Fax: (11) 5083-3736 e 5571-5000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)