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OpenTrials
Completed

NCT Number: NCT04557852

Mid-term Follow-up for Tailored ATVM

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.

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Key information

Conditions

Lower Urinary Tract Symptoms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Urological Manifestations

Age range

20 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATVM

Procedure

Tailored anterior transvaginal mesh for pelvic organ prolapse

Primary outcomes

  1. 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

  1. Overactive bladder syndrome

    Time frame: November 2011 to December 2015

    Urinary urgency, with or without incontinence, may accompany with urinary frequency and nocturia.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 22, 2020
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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