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Clinical Trials/NCT04557852
NCT04557852
Completed
Not Applicable

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

National Taiwan University Hospital1 site in 1 country160 target enrollmentNovember 1, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
National Taiwan University Hospital
Enrollment
160
Locations
1
Primary Endpoint
Voiding difficulty
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2011
End Date
December 31, 2015
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Voiding difficulty

Time Frame: November 2011 to December 2015

Weak stream of urination, intermittency, strain to void or incomplete empty sensation after the anterior transvaginal mesh surgery

Secondary Outcomes

  • Overactive bladder syndrome(November 2011 to December 2015)

Study Sites (1)

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