Urodynamic Stress IncontinenceNCT04978714
USI and/or DO in Women With Cystocele Before and After Cystocele Repair
An observational study of Urodynamic Stress Incontinence and Detrusor Overactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The changes of lower urinary tract function after cystocele repair are important for perioperative consultation and management. Thus, the aim of this retrospective study was to evaluate the prevalence of urodynamic stress incontinence and/or detrusor overactivity in women with ≥ stage II cystocele and the changes of… Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Urodynamic Stress Incontinence, Detrusor Overactivity
- What is being tested?
- Cystocele repair
- Type of treatment
- Surgery or procedure
- How many people
- 483 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2010to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair
Who may be able to join
- Women with ≥ stage II cystocele
- Received cystocele repair
- Complete urodynamic study before and after surgery
Who cannot join
- Incomplete data
- Chronic infection
- Recurrent surgery for cystocele
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Urodynamic Stress Incontinence and/or Detrusor Overactivity in Women With Cystocele and the Changes of Continence Function After Cystocele Repair
The changes of lower urinary tract function after cystocele repair are important for perioperative consultation and management. Thus, the aim of this retrospective study was to evaluate the prevalence of urodynamic stress incontinence and/or detrusor overactivity in women with ≥ stage II cystocele and the changes of incontinence function after cystocele repair.
Read the detailed description
Between November 2010 and October 2020, all women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair were reviewed. Those women who had complete data of preoperative and postoperative 3-month follow-up urodynamic data were excluded from this study. Urodynamic stress incontinence was diagnosed by the finding of involuntary leakage during filling cystometry or stress urethral pressure profile, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction. Detrusor overactivity was defined as the occurrence of involuntary detrusor contractions during filling cytometry.
STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression tests were used for statistical analysis as appropriate. A p < 0.05 was considered as statistically significant.
- Being tested
- Cystocele repair
- Keywords
- Urodynamic stress incontinence, Detrusor Overactivity, Cystocele
- Medical subject headings
- Urinary Bladder, Overactive, Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystocele repairProcedure or surgery
Fascial repair for endopelvic fascia and anterior colporrhaphy
| Study group | Role | What they receive |
|---|---|---|
| Women with cystocele | All women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair Receives: Procedure: Cystocele repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamic stress incontinence
the finding of involuntary leakage during filling cystometry or stress urethral pressure profile, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction
Measured: November 2010 and October 2020
Detrusor overactivity
the occurrence of involuntary detrusor contractions during filling cytometry
Measured: November 2010 and October 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Nov 2010
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urodynamic Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978714
- Sponsor's protocol ID
- 202105056RINC
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data is available under reasonable request
Publications
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
PubMed 19941278Lamblin 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.
PubMed 26337427Leron E, Weintraub AY, Mastrolia SA, Schwarzman P. Overactive Bladder Syndrome: Evaluation and Management. Curr Urol. 2018 Mar;11(3):117-125. doi: 10.1159/000447205. Epub 2018 Feb 20.
PubMed 29692690Hsiao 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.
PubMed 28754926Hsiao SM, Chang TC, Wu PC, Lin HH. Predictors of an improvement in the severity of concomitant urodynamic stress incontinence after transvaginal mesh surgery for pelvic organ prolapse. J Formos Med Assoc. 2020 May;119(5):917-924. doi: 10.1016/j.jfma.2019.12.016. Epub 2020 Mar 5.
PubMed 32146026Huang 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.
PubMed 26573101
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Urodynamic Stress Incontinence and/or Detrusor Overactivity in Women With Cystocele and the Changes of Continence Function After Cystocele Repair
- ClinicalTrials.gov ID
- NCT04978714
- Acronym / sponsor ID
- 202105056RINC
- Keywords
- Urodynamic stress incontinence, Detrusor Overactivity, Cystocele
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2010 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The changes of lower urinary tract function after cystocele repair are important for perioperative consultation and management. Thus, the aim of this retrospective study was to evaluate the prevalence of urodynamic stress incontinence and/or detrusor overactivity in women with ≥ stage II cystocele and the changes of incontinence function after cystocele repair.
Detailed description
Between November 2010 and October 2020, all women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair were reviewed. Those women who had complete data of preoperative and postoperative 3-month follow-up urodynamic data were excluded from this study. Urodynamic stress incontinence was diagnosed by the finding of involuntary leakage during filling cystometry or stress urethral pressure profile, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction. Detrusor overactivity was defined as the occurrence of involuntary detrusor contractions during filling cytometry.
STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression tests were used for statistical analysis as appropriate. A p < 0.05 was considered as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with cystocele | – | Procedure: Cystocele repairAll women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair
Key inclusion criteria (3 listed)
- Women with ≥ stage II cystocele
- Received cystocele repair
- Complete urodynamic study before and after surgery
Key exclusion criteria (3 listed)
- Incomplete data
- Chronic infection
- Recurrent surgery for cystocele
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cystocele repairFascial repair for endopelvic fascia and anterior colporrhaphy | Procedure or surgery | Women with cystocele |
Primary outcome
Urodynamic stress incontinence
Time frame: November 2010 and October 2020
the finding of involuntary leakage during filling cystometry or stress urethral pressure profile, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction
Detrusor overactivity
Time frame: November 2010 and October 2020
the occurrence of involuntary detrusor contractions during filling cytometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Results publication: PubMed 19941278Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
- Results publication: PubMed 26337427Lamblin 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.
- Results publication: PubMed 29692690Leron E, Weintraub AY, Mastrolia SA, Schwarzman P. Overactive Bladder Syndrome: Evaluation and Management. Curr Urol. 2018 Mar;11(3):117-125. doi: 10.1159/000447205. Epub 2018 Feb 20.
- Results publication: PubMed 28754926Hsiao 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.
- Results publication: PubMed 32146026Hsiao SM, Chang TC, Wu PC, Lin HH. Predictors of an improvement in the severity of concomitant urodynamic stress incontinence after transvaginal mesh surgery for pelvic organ prolapse. J Formos Med Assoc. 2020 May;119(5):917-924. doi: 10.1016/j.jfma.2019.12.016. Epub 2020 Mar 5.
- Results publication: PubMed 26573101Huang 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.
- Individual participant dataSharing planned: Undecided. Individual participant data is available under reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Hsiung Lin, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urodynamic Stress Incontinence and Detrusor Overactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urodynamic stress incontinence (time frame: November 2010 and October 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04978714, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.