Mid-term Follow-up for Tailored ATVM

Study Overview
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Brief Summary
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Lower urinary tract symptoms may change after pelvic organ prolapse surgery. Thus, the aim of this study was to elucidate (1) the changes of lower urinary tract symptoms and (2) the changes in values of urodynamic parameters between baseline and after pelvic organ prolapse surgery.

Detailed Description
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Between November 2011 and December 2015, medical records of all consecutive women who underwent anterior transvaginal mesh surgery (ATVM) but without concomitant mid-urethral sling surgery were reviewed. Data of pre- and post-operative lower urinary tract symptoms and urodynamic parameters were compared. The bladder outlet obstruction was defined when the detrusor pressure at maximum flow rate was not less than 40cmH2O, and the maximum flow rate was less than 12 mL/s. Overactive bladder syndrome, detrusor overactivity, bladder oversensitivity and urodynamic stress incontinence were also recognized as international continence society definition. STATA software was used for statistical analysis. Wilcoxon signed-rank test or McNemar's test was used for statistical analysis as appropriate. P < 0.05 was considered as statistically significant.

Official Title
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Clinical Outcome and Urodynamic Changes of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse: a Mid-term Follow-up With a Median Duration of 30 Months

Conditions
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Lower Urinary Tract Symptoms

Intervention / Treatment
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* Procedure: ATVM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with pelvic organ prolapse Women received anterior transvaginal mesh surgery Exclusion Criteria: Concomitant mid-urethral sling surgery Chronic urinary tract infection Interstitial cystitis Malignancy history in pelvic organ Ever received pelvic radiation Concomitant transabdominal surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Anterior transvaginal mesh group<br>Women received anterior transvaginal mesh surgery without concomitant mid-urethral sling surgery. | Procedure: ATVM<br>* Tailored anterior transvaginal mesh for pelvic organ prolapse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voiding difficulty | Weak stream of urination, intermittency, strain to void or incomplete empty sensation after the anterior transvaginal mesh surgery | November 2011 to December 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder syndrome | Urinary urgency, with or without incontinence, may accompany with urinary frequency and nocturia. | November 2011 to December 2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic organ prolapse, Transvaginal mesh, lower urinary tract symptoms, Urodynamic study