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Four-arm Mesh for Vaginal Stump Prolapse

NCT03809806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-01-18

No results posted yet for this study

Summary

To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification \[POP-Q\] system staging).

Conditions

  • Pelvic Organ Prolapse
  • Sexual Function Abnormal

Interventions

PROCEDURE

4-arm polypropylene mesh surgery

Pelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments.

DIAGNOSTIC_TEST

The Female Sexual Function Index (FSFI) questionnaire

patients fulfilled questionnaire before and 1 year after procedure

DIAGNOSTIC_TEST

King Health Questionnaire (KHQ)

patients fulfilled questionnaire before and 1 year after procedure

DIAGNOSTIC_TEST

Pelvic Organ Prolapse Quantification (POPQ) staging

Pelvic Organ Prolapse staging before and 1 year after the procedure

DIAGNOSTIC_TEST

Postoperative questionnaire

Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure

DIAGNOSTIC_TEST

The Short Form Health Survey (SF 36) questionnaire

patients fulfilled questionnaire before and 1 year after procedure

Sponsors & Collaborators

  • Medical University of Lublin

    lead OTHER

Principal Investigators

  • Tomasz Rechberger, Professor · 2nd Gynecology Department Medical University in Lublin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Poland

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 NCT03809806 on ClinicalTrials.gov