Four-arm Mesh for Vaginal Stump Prolapse

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse; Sexual Function Abnormal
• Interventions: 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

• Registration Number: NCT03809806
• Lead Sponsor: Medical University of Lublin

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-17
• Last Update Submitted: 2019-01-17
• Study First Posted: 2019-01-18
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

• malignant diseases
• unability to understand informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients after hysterectomy	4-arm polypropylene mesh surgery	modified anterior transvaginal mesh surgery
patients after hysterectomy	The Female Sexual Function Index (FSFI) questionnaire	modified anterior transvaginal mesh surgery
patients after hysterectomy	The Short Form Health Survey (SF 36) questionnaire	modified anterior transvaginal mesh surgery
patients after hysterectomy	King Health Questionnaire (KHQ)	modified anterior transvaginal mesh surgery
patients after hysterectomy	Postoperative questionnaire	modified anterior transvaginal mesh surgery
patients after hysterectomy	Pelvic Organ Prolapse Quantification (POPQ) staging	modified anterior transvaginal mesh surgery

Primary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure	1 year	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

Name	Time	Method
quality of life 1 year after procedure	1 year	assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36)
Sexual function 1 year after procedure	1 year	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	1 year	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

Trial Locations

Locations (1)

2nd Gynecology Department; 🇵🇱 Lublin, Poland