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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04557852

Enrollment

160

Registered

2020-09-22

Start date

2011-11-01

Completion date

2015-12-31

Last updated

2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Tract Symptoms

Keywords

Pelvic organ prolapse, Transvaginal mesh, lower urinary tract symptoms, Urodynamic study

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.

Interventions

PROCEDUREATVM

Tailored anterior transvaginal mesh for pelvic organ prolapse

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026