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Trials / Completed

CompletedNCT04557852

Mid-term Follow-up for Tailored ATVM

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

Status
Completed
Phase
Study type
Observational
Enrollment
160 (actual)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
Female
Age
20 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREATVMTailored anterior transvaginal mesh for pelvic organ prolapse

Timeline

Start date
2011-11-01
Primary completion
2015-12-31
Completion
2015-12-31
First posted
2020-09-22
Last updated
2020-09-22

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT04557852. Inclusion in this directory is not an endorsement.

Mid-term Follow-up for Tailored ATVM (NCT04557852) · Clinical Trials Directory