NCT03809806

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

4 years

First QC Date

January 16, 2019

Last Update Submit

January 17, 2019

Conditions

Pelvic Organ ProlapseSexual Function Abnormal

Keywords

vaginal stump prolapsesexual functionquality of life

Outcome Measures

Primary Outcomes (1)

  • Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure

    assessment of POPQ 1 year after mesh operation, Pelvic Organ Prolapse Quantification system (POP-Q) refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women. It provides a standardized tool for documenting, comparing, and communicating clinical findings with proven interobserver and intraobserver reliability

    1 year

Secondary Outcomes (3)

  • Sexual function 1 year after procedure

    1 year

  • Urinary incontinence 1 year after procedure

    1 year

  • quality of life 1 year after procedure

    1 year

Study Arms (1)

patients after hysterectomy

OTHER

modified anterior transvaginal mesh surgery

Procedure: 4-arm polypropylene mesh surgeryDiagnostic Test: The Female Sexual Function Index (FSFI) questionnaireDiagnostic Test: King Health Questionnaire (KHQ)Diagnostic Test: Pelvic Organ Prolapse Quantification (POPQ) stagingDiagnostic Test: Postoperative questionnaireDiagnostic Test: The Short Form Health Survey (SF 36) questionnaire

Interventions

4-arm polypropylene mesh surgeryPROCEDURE

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.

patients after hysterectomy
The Female Sexual Function Index (FSFI) questionnaireDIAGNOSTIC_TEST

patients fulfilled questionnaire before and 1 year after procedure

patients after hysterectomy
King Health Questionnaire (KHQ)DIAGNOSTIC_TEST

patients fulfilled questionnaire before and 1 year after procedure

patients after hysterectomy
Pelvic Organ Prolapse Quantification (POPQ) stagingDIAGNOSTIC_TEST

Pelvic Organ Prolapse staging before and 1 year after the procedure

patients after hysterectomy
Postoperative questionnaireDIAGNOSTIC_TEST

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

patients after hysterectomy
The Short Form Health Survey (SF 36) questionnaireDIAGNOSTIC_TEST

patients fulfilled questionnaire before and 1 year after procedure

patients after hysterectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • malignant diseases
  • unability to understand informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Gynecology Department

Lublin, 20-954, Poland

Location

MeSH Terms

Conditions

Pelvic Organ ProlapseSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Study Officials

  • Tomasz Rechberger, Professor

    2nd Gynecology Department Medical University in Lublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients with vaginal stump prolapse who had undergone hysterectomy in the past
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 18, 2019

Study Start

January 1, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)