An observational study in Cystocele, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by National Taiwan University Hospital · Observational
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.
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.
71 studies on the registry are indexed under Cystocele; 5 are open to participants now.
This study's enrollment of 623 is above the median of 292 across 23 observational studies indexed under Cystocele.
Browse Cystocele studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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All medical records of women with ≥ POP-Q stage II cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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%.
Diagnostic Test: Urodynamic study
The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s.
Diagnostic Test: Urodynamic study
Those women without DU or BOO were allocated to the non-DU/BOO group.
Diagnostic Test: Urodynamic study
The urodynamic assessment included uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and a stress urethral pressure profile with patient in sitting position \[14\]. A 20-minute pad test for each woman was also performed \[15, 16\]. Multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston) was used. All terminology conformed to the standards recommended by the ICS \[3\]. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid interobserver variability.
Also known as: Pad test
DU or BOO
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 % \[1\]. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s \[1\]. BVE = voided volume / (voided volume+ PVR) x 100%.
Time frame: Between November 2010 and September 2018
Plan to share: No — There is no plan to make IPD available to other researchers.
Ran from Nov 2010 to primary completion in Sep 2018, 94 months.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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