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Mid-term Follow-up for Tailored ATVM

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National Taiwan University

Status

Completed

Conditions

Lower Urinary Tract Symptoms

Treatments

Procedure: ATVM

Study type

Observational

Funder types

Other

Identifiers

NCT04557852
202006093RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

Female

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

160 participants in 1 patient group

Anterior transvaginal mesh group
Description:
Women received anterior transvaginal mesh surgery without concomitant mid-urethral sling surgery.
Treatment:
Procedure: ATVM

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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