Four-arm Mesh for Vaginal Stump Prolapse

Study Overview
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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).

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.

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

Conditions
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Pelvic Organ Prolapse, Sexual Function Abnormal

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with vaginal stump prolapse who had undergone hysterectomy in the past
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients after hysterectomy<br>modified anterior transvaginal mesh surgery | Procedure: 4-arm polypropylene mesh surgery<br>* 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.<br>Diagnostic Test: The Female Sexual Function Index (FSFI) questionnaire<br>* patients fulfilled questionnaire before and 1 year after procedure<br>Diagnostic Test: King Health Questionnaire (KHQ)<br>* patients fulfilled questionnaire before and 1 year after procedure<br>Diagnostic Test: Pelvic Organ Prolapse Quantification (POPQ) staging<br>* Pelvic Organ Prolapse staging before and 1 year after the procedure<br>Diagnostic Test: Postoperative questionnaire<br>* Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure<br>Diagnostic Test: The Short Form Health Survey (SF 36) questionnaire<br>* patients fulfilled questionnaire before and 1 year after procedure<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal stump prolapse, sexual function, quality of life