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A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients

NCT02935803 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-10-18

No results posted yet for this study

Summary

An increasing number of specific procedures have been described for the surgical repair of pelvic organ prolapse (POP) and concomitant stress urinary incontinence (SUI). The investigators introduced an alternative operative method for POP-Q II-III repair and anti-incontinence with the trans vaginal mesh (TVM) anterior edge fixed to the periurethral tissues at the level of mid-urethra. The efficacy and short- and long-term complication profile, of this new surgical technique as compared with those of non-modified TVM.

Conditions

  • Uterine Prolapse
  • Urinary Stress Incontinence
  • Side Effects

Interventions

PROCEDURE

Trans-vaginal Mesh operation

Modified the transobturator TVM operation reported by Sergent et al. by inserting a stabilizing suture, which fixing the anterior edge of the mesh to the paraurethral tissues at the level of the mid-urethra with two non-resolvable anchoring stitches thereby promoting the proper elevation and closure of the urethra

Sponsors & Collaborators

  • Szeged University

    lead OTHER

Principal Investigators

  • Zoltan Fekete, M.D. · Szeged University

  • Gábor Németh, M.D., Ph.D. · Szeged University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-06-30
Completion
2020-06-30

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02935803 on ClinicalTrials.gov