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Four-arm Mesh for Vaginal Stump Prolapse

Primary Purpose

Pelvic Organ Prolapse, Sexual Function Abnormal

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
4-arm polypropylene mesh surgery
The Female Sexual Function Index (FSFI) questionnaire
King Health Questionnaire (KHQ)
Pelvic Organ Prolapse Quantification (POPQ) staging
Postoperative questionnaire
The Short Form Health Survey (SF 36) questionnaire
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring vaginal stump prolapse, sexual function, quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • malignant diseases
  • unability to understand informed consent

Sites / Locations

  • 2nd Gynecology Department

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients after hysterectomy

Arm Description

modified anterior transvaginal mesh surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sexual function 1 year after procedure
assessment of sexual function before and 1 year after the procedure with the use of The Female Sexual Function Index questionnaire
Urinary incontinence 1 year after procedure
assessment of urinary incontinence before and 1 year after the procedure with the use of the Urogenital Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7) questionnaire
quality of life 1 year after procedure
assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36)

Full Information

First Posted
January 16, 2019
Last Updated
January 17, 2019
Sponsor
Medical University of Lublin
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1. Study Identification

Unique Protocol Identification Number
NCT03809806
Brief Title
Four-arm Mesh for Vaginal Stump Prolapse
Official Title
Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Sexual Function Abnormal
Keywords
vaginal stump prolapse, sexual function, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with vaginal stump prolapse who had undergone hysterectomy in the past
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients after hysterectomy
Arm Type
Other
Arm Description
modified anterior transvaginal mesh surgery
Intervention Type
Procedure
Intervention Name(s)
4-arm polypropylene mesh surgery
Intervention Description
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
Diagnostic Test
Intervention Name(s)
The Female Sexual Function Index (FSFI) questionnaire
Intervention Description
patients fulfilled questionnaire before and 1 year after procedure
Intervention Type
Diagnostic Test
Intervention Name(s)
King Health Questionnaire (KHQ)
Intervention Description
patients fulfilled questionnaire before and 1 year after procedure
Intervention Type
Diagnostic Test
Intervention Name(s)
Pelvic Organ Prolapse Quantification (POPQ) staging
Intervention Description
Pelvic Organ Prolapse staging before and 1 year after the procedure
Intervention Type
Diagnostic Test
Intervention Name(s)
Postoperative questionnaire
Intervention Description
Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure
Intervention Type
Diagnostic Test
Intervention Name(s)
The Short Form Health Survey (SF 36) questionnaire
Intervention Description
patients fulfilled questionnaire before and 1 year after procedure
Primary Outcome Measure Information:
Title
Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Sexual function 1 year after procedure
Description
assessment of sexual function before and 1 year after the procedure with the use of The Female Sexual Function Index questionnaire
Time Frame
1 year
Title
Urinary incontinence 1 year after procedure
Description
assessment of urinary incontinence before and 1 year after the procedure with the use of the Urogenital Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7) questionnaire
Time Frame
1 year
Title
quality of life 1 year after procedure
Description
assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36)
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy Exclusion Criteria: malignant diseases unability to understand informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Rechberger, Professor
Organizational Affiliation
2nd Gynecology Department Medical University in Lublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Gynecology Department
City
Lublin
ZIP/Postal Code
20-954
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Four-arm Mesh for Vaginal Stump Prolapse

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