Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele
NCT ID: NCT04184128
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
623 participants
OBSERVATIONAL
2010-11-01
2018-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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%.
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.
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.
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.
Non-DU/BOO group
Those women without DU or BOO were allocated to the non-DU/BOO group.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female
Exclusion Criteria
20 Years
85 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Taiwan University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ho-Hsiung Lin, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Taiwan University Hospital
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
Lamblin G, Delorme E, Cosson M, Rubod C. Cystocele and functional anatomy of the pelvic floor: review and update of the various theories. Int Urogynecol J. 2016 Sep;27(9):1297-305. doi: 10.1007/s00192-015-2832-4. Epub 2015 Sep 4.
Frigerio M, Manodoro S, Cola A, Palmieri S, Spelzini F, Milani R. Detrusor underactivity in pelvic organ prolapse. Int Urogynecol J. 2018 Aug;29(8):1111-1116. doi: 10.1007/s00192-017-3532-z. Epub 2017 Dec 21.
Hsiao SM, Lin HH, Kuo HC. Videourodynamic Studies of Women with Voiding Dysfunction. Sci Rep. 2017 Jul 28;7(1):6845. doi: 10.1038/s41598-017-07163-2.
Huang WC, Yang SH, Yang JM. Clinical Importance and Surgical Outcomes of Green Type III Cystocele in Women With Anterior Vaginal Prolapse. J Ultrasound Med. 2015 Dec;34(12):2279-85. doi: 10.7863/ultra.14.11066. Epub 2015 Nov 16.
Salinas Casado J, Adot Zurbano JM, Dambros M, Virseda Chamorro M, Ramirez Fernandez JC, Moreno Sierra J, Marcos Diaz J, Silmi Moyano A. [Factors for voiding dysfunction and cystocele]. Arch Esp Urol. 2005 May;58(4):316-23. doi: 10.4321/s0004-06142005000400006. Spanish.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201907008RINC
Identifier Type: -
Identifier Source: org_study_id