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Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele

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National Taiwan University

Status

Completed

Conditions

Cystocele

Treatments

Diagnostic Test: Urodynamic study

Study type

Observational

Funder types

Other

Identifiers

NCT04184128
201907008RINC

Details and patient eligibility

About

Women with cystocele may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). However, the impact of cystocele repair on the rates of DU and BOO remained obscure. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the impact of cystocele repair on the rates of DU and BOO.

Full description

Between November 2010 and September 2018, all women with ≥ POP-Q stage II cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. Those women who have no complete data of maximum flow rate (Qmax), voided volume, post-void residual volume (PVR) and detrusor pressure at a maximum flow rate (PdetQmax) were excluded from this study. The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s. BVE = voided volume / (voided volume+ PVR) x 100%. Those women without DU or BOO were allocated to the non-DU/BOO group.

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 statistically significant.

Enrollment

623 patients

Sex

Female

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ POP-Q stage II cystocele
  • Female

Exclusion criteria

  • Those women who have no complete data of maximum flow rate (Qmax), voided volume, post void residual volume (PVR) and detrusor pressure at maximum flow rate (PdetQmax) were excluded from this study.

Trial design

623 participants in 3 patient groups

Detrusor underactivity
Description:
The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. BVE = voided volume / (voided volume+ PVR) x 100%.
Treatment:
Diagnostic Test: Urodynamic study
Bladder outlet obstruction
Description:
The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s.
Treatment:
Diagnostic Test: Urodynamic study
Non-DU/BOO group
Description:
Those women without DU or BOO were allocated to the non-DU/BOO group.
Treatment:
Diagnostic Test: Urodynamic study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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