Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04184128
Collaborator
(none)
623
1
94.9
6.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Urodynamic study

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
623 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele and Changes of Voiding Function After Cystocele
Actual Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Detrusor underactivity

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 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.
Other Names:
  • Pad test
  • Bladder outlet obstruction

    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
    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.
    Other Names:
  • Pad test
  • Non-DU/BOO group

    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.
    Other Names:
  • Pad test
  • Outcome Measures

    Primary Outcome Measures

    1. DU or BOO [Between November 2010 and September 2018]

      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%.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Ho-Hsiung Lin, PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04184128
    Other Study ID Numbers:
    • 201907008RINC
    First Posted:
    Dec 3, 2019
    Last Update Posted:
    Dec 9, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 9, 2019