Four-arm Mesh for Vaginal Stump Prolapse

Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes

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).

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Sexual Function Abnormal
• Intervention / Treatment: Procedure: 4-arm polypropylene mesh surgery; Diagnostic test: The Female Sexual Function Index (FSFI) questionnaire; Diagnostic test: King Health Questionnaire (KHQ); Diagnostic test: Pelvic Organ Prolapse Quantification (POPQ) staging; Diagnostic test: Postoperative questionnaire; Diagnostic test: The Short Form Health Survey (SF 36) questionnaire

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland, 20-954
    • 2nd Gynecology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• malignant diseases
• unability to understand informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: patients after hysterectomy; modified anterior transvaginal mesh surgery

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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	1 year
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)	1 year

Collaborators and Investigators

• Sponsor: Medical University of Lublin
• Investigators: Principal Investigator: Tomasz Rechberger, Professor, 2nd Gynecology Department Medical University in Lublin

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; sexual function; vaginal stump prolapse
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 02/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No