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Four-arm Mesh for Vaginal Stump Prolapse

NCT ID: NCT03809806

Last Updated: 2019-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2017-12-31

Brief Summary

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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).

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Detailed Description

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Pelvic reconstructive procedures were primarily performed using the transvaginal four arm polypropylene mesh, which was inserted through: upper arms- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent hysterectomy in the past apart from one which underwent vaginal hysterectomy during the procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective evaluations included Pelvic Organ Prolapse Quantification \[POP-Q\] staging, preoperative and 1-year postoperative questionnaires were performed.

Conditions

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Pelvic Organ Prolapse Sexual Function Abnormal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients with vaginal stump prolapse who had undergone hysterectomy in the past
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients after hysterectomy

modified anterior transvaginal mesh surgery

Group Type OTHER

4-arm polypropylene mesh surgery

Intervention Type PROCEDURE

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.

The Female Sexual Function Index (FSFI) questionnaire

Intervention Type DIAGNOSTIC_TEST

patients fulfilled questionnaire before and 1 year after procedure

King Health Questionnaire (KHQ)

Intervention Type DIAGNOSTIC_TEST

patients fulfilled questionnaire before and 1 year after procedure

Pelvic Organ Prolapse Quantification (POPQ) staging

Intervention Type DIAGNOSTIC_TEST

Pelvic Organ Prolapse staging before and 1 year after the procedure

Postoperative questionnaire

Intervention Type DIAGNOSTIC_TEST

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

The Short Form Health Survey (SF 36) questionnaire

Intervention Type DIAGNOSTIC_TEST

patients fulfilled questionnaire before and 1 year after procedure

Interventions

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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.

Intervention Type PROCEDURE

The Female Sexual Function Index (FSFI) questionnaire

patients fulfilled questionnaire before and 1 year after procedure

Intervention Type DIAGNOSTIC_TEST

King Health Questionnaire (KHQ)

patients fulfilled questionnaire before and 1 year after procedure

Intervention Type DIAGNOSTIC_TEST

Pelvic Organ Prolapse Quantification (POPQ) staging

Pelvic Organ Prolapse staging before and 1 year after the procedure

Intervention Type DIAGNOSTIC_TEST

Postoperative questionnaire

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

Intervention Type DIAGNOSTIC_TEST

The Short Form Health Survey (SF 36) questionnaire

patients fulfilled questionnaire before and 1 year after procedure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy

Exclusion Criteria

* malignant diseases
* unability to understand informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Paweł Miotła

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomasz Rechberger, Professor

Role: PRINCIPAL_INVESTIGATOR

2nd Gynecology Department Medical University in Lublin

Locations

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2nd Gynecology Department

Lublin, , Poland

Site Status

Countries

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Poland

Other Identifiers

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02/2019

Identifier Type: -

Identifier Source: org_study_id

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