Factors Affecting the Improvement of Severity of Concomitant USI After a Novel TVM Surgery for Women With POP

Study Overview
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Brief Summary
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Background/Purpose: A novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery. Patients and Methods: All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline [i.e., 100 * (postoperative pad weight - baseline pad weight)/baseline pad weight]. Expected Results: The investigators will get the factors responsible for anti-incontinence effect of this novel anterior TVM surgery. Key Words: pelvic organ prolapse, stress urinary incontinence, pad test, urodynamic stress incontinence

Detailed Description
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Background/Purpose: A novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery. Methods: All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries between November 2011 and December 2015 at the Department of Obstetrics & Gynecology, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline [i.e., 100 * (postoperative pad weight - baseline pad weight)/baseline pad weight]. Expected Results: The investigators will get the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.

Official Title
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Factors Affecting the Improvement of Severity of Concomitant Urodynamic Stress Incontinence After a Novel Transvaginal Mesh Surgery for Women With Pelvic Organ Prolapse

Conditions
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Concomitant Conditions

Intervention / Treatment
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* Procedure: The novel anterior TVM surgeries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Diagnosed with pelvic organ prolapse and concomitant overt or occult urodynamic stress incontinence Received the novel anterior transvaginal mesh surgery. Exclusion Criteria: Pregnant women, prepare for pregnancy or younger than 20-year-old Significant severe urinary urgency Mixed urinary incontinence with dominant urgency incontinence Regular urethral catheterization or intermittent self-catheterization Urinary tract infection (UTI) or chronic inflammation in recent 2 weeks before operation Bladder calculus A history of pelvic radiotherapy Preexisting malignant pelvic tumors.

Ages Eligible for Study
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Minimum Age: 20 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All women in this study<br>All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline [i.e., 100 * (postoperative pad weight - baseline pad weight)/baseline pad weight]. | Procedure: The novel anterior TVM surgeries<br>* A novel transvaginal mesh (TVM) surgery fro women with pelvic organ prolapse (POP) had been reported. Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical outcomes and urodynamic effects of tailored transvaginal mesh surgery for pelvic organ prolapse. Biomed Res Int http;//dx.doi.org/10.1155/2015/191258.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of urodynamic stress incontinence | Preoperative and postoperative urodynamic studies to detect USI | 2011/11/01-2015/12/31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of stress urinary incontinence | Preoperative and postoperative 20-minute pad test changes | 2011/11/01-2015/12/31 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic organ prolapse, Transvaginal mesh, Urodynamic stress incontinence