Lower Urinary Tract SymptomsNCT04557852
Mid-term Follow-up for Tailored ATVM
An observational study of Lower Urinary Tract Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Lower urinary tract symptoms may change after pelvic organ prolapse surgery. Thus, the aim of this study was to elucidate (1) the changes of lower urinary tract symptoms and (2) the changes in values of urodynamic parameters between baseline and after pelvic organ prolapse surgery. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- ATVM
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2011to 31 Dec 2015
- 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: Between November 2011 and December 2015, medical records of all consecutive women who underwent anterior transvaginal mesh surgery for their advanced pelvic organ prolapse were reviewed.
Who may be able to join
- Women with pelvic organ prolapse
- Women received anterior transvaginal mesh surgery
Who cannot join
- Concomitant mid-urethral sling surgery
- Chronic urinary tract infection
- Interstitial cystitis
- Malignancy history in pelvic organ
- Ever received pelvic radiation
- Concomitant transabdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome and Urodynamic Changes of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse: a Mid-term Follow-up With a Median Duration of 30 Months
Lower urinary tract symptoms may change after pelvic organ prolapse surgery. Thus, the aim of this study was to elucidate (1) the changes of lower urinary tract symptoms and (2) the changes in values of urodynamic parameters between baseline and after pelvic organ prolapse surgery.
Read the detailed description
Between November 2011 and December 2015, medical records of all consecutive women who underwent anterior transvaginal mesh surgery (ATVM) but without concomitant mid-urethral sling surgery were reviewed. Data of pre- and post-operative lower urinary tract symptoms and urodynamic parameters were compared. The bladder outlet obstruction was defined when the detrusor pressure at maximum flow rate was not less than 40cmH2O, and the maximum flow rate was less than 12 mL/s. Overactive bladder syndrome, detrusor overactivity, bladder oversensitivity and urodynamic stress incontinence were also recognized as international continence society definition. 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 as statistically significant.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- ATVM
- Keywords
- Pelvic organ prolapse, Transvaginal mesh, lower urinary tract symptoms, Urodynamic study
- Medical subject headings
- Lower Urinary Tract Symptoms, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATVMProcedure or surgery
Tailored anterior transvaginal mesh for pelvic organ prolapse
| Study group | Role | What they receive |
|---|---|---|
| Anterior transvaginal mesh group | Women received anterior transvaginal mesh surgery without concomitant mid-urethral sling surgery. Receives: Procedure: ATVM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voiding difficulty
Weak stream of urination, intermittency, strain to void or incomplete empty sensation after the anterior transvaginal mesh surgery
Measured: November 2011 to December 2015
Secondary outcomes (1)
Overactive bladder syndrome
Urinary urgency, with or without incontinence, may accompany with urinary frequency and nocturia.
Measured: November 2011 to December 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Nov 2011
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- 160 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
- NCT04557852
- Sponsor's protocol ID
- 202006093RIND
- Status last verified
- Jul 2020
- First submitted
- 8 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared 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 19941278Wu PC, Wu CH, Lin KL, Liu Y, Loo Z, Lee YC, Long CY. Predictors for de novo stress urinary incontinence following pelvic reconstruction surgery with transvaginal single-incisional mesh. Sci Rep. 2019 Dec 16;9(1):19166. doi: 10.1038/s41598-019-55512-0.
PubMed 31844157Long CY, Wang CL, Lin KL, Ker CR, Loo Z, Liu Y, Wu PC. Laparoscopic Long Mesh Surgery with Augmented Round Ligaments: A Novel Uterine Preservation Procedure For Apical Pelvic Organ Prolapse. Sci Rep. 2020 Apr 20;10(1):6615. doi: 10.1038/s41598-020-63725-x.
PubMed 32313187Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse. Biomed Res Int. 2015;2015:191258. doi: 10.1155/2015/191258. Epub 2015 Nov 8.
PubMed 26634203Chang TC, Hsiao SM, Wu PC, Chen CH, Wu WY, Lin HH. Comparison of clinical outcomes between tailored transvaginal mesh surgery and native tissue repair for pelvic organ prolapse. J Formos Med Assoc. 2019 Dec;118(12):1623-1632. doi: 10.1016/j.jfma.2019.08.034. Epub 2019 Sep 18.
PubMed 31542332
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome and Urodynamic Changes of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse: a Mid-term Follow-up With a Median Duration of 30 Months
- ClinicalTrials.gov ID
- NCT04557852
- Acronym / sponsor ID
- 202006093RIND
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Pelvic organ prolapse, Transvaginal mesh, lower urinary tract symptoms, Urodynamic study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 22 Sep 2020 (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.
Lower urinary tract symptoms may change after pelvic organ prolapse surgery. Thus, the aim of this study was to elucidate (1) the changes of lower urinary tract symptoms and (2) the changes in values of urodynamic parameters between baseline and after pelvic organ prolapse surgery.
Detailed description
Between November 2011 and December 2015, medical records of all consecutive women who underwent anterior transvaginal mesh surgery (ATVM) but without concomitant mid-urethral sling surgery were reviewed. Data of pre- and post-operative lower urinary tract symptoms and urodynamic parameters were compared. The bladder outlet obstruction was defined when the detrusor pressure at maximum flow rate was not less than 40cmH2O, and the maximum flow rate was less than 12 mL/s. Overactive bladder syndrome, detrusor overactivity, bladder oversensitivity and urodynamic stress incontinence were also recognized as international continence society definition. 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 as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior transvaginal mesh group | – | Procedure: ATVMWomen received anterior transvaginal mesh surgery without concomitant mid-urethral sling surgery. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between November 2011 and December 2015, medical records of all consecutive women who underwent anterior transvaginal mesh surgery for their advanced pelvic organ prolapse were reviewed.
Key inclusion criteria (2 listed)
- Women with pelvic organ prolapse
- Women received anterior transvaginal mesh surgery
Key exclusion criteria (6 listed)
- Concomitant mid-urethral sling surgery
- Chronic urinary tract infection
- Interstitial cystitis
- Malignancy history in pelvic organ
- Ever received pelvic radiation
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 |
|---|---|---|
| ATVMTailored anterior transvaginal mesh for pelvic organ prolapse | Procedure or surgery | Anterior transvaginal mesh group |
Primary outcome
Voiding difficulty
Time frame: November 2011 to December 2015
Weak stream of urination, intermittency, strain to void or incomplete empty sensation after the anterior transvaginal mesh surgery
1 secondary outcome
Overactive bladder syndrome
Time frame: November 2011 to December 2015
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 22 Sep 2020.
- 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 31844157Wu PC, Wu CH, Lin KL, Liu Y, Loo Z, Lee YC, Long CY. Predictors for de novo stress urinary incontinence following pelvic reconstruction surgery with transvaginal single-incisional mesh. Sci Rep. 2019 Dec 16;9(1):19166. doi: 10.1038/s41598-019-55512-0.
- Results publication: PubMed 32313187Long CY, Wang CL, Lin KL, Ker CR, Loo Z, Liu Y, Wu PC. Laparoscopic Long Mesh Surgery with Augmented Round Ligaments: A Novel Uterine Preservation Procedure For Apical Pelvic Organ Prolapse. Sci Rep. 2020 Apr 20;10(1):6615. doi: 10.1038/s41598-020-63725-x.
- Results publication: PubMed 26634203Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse. Biomed Res Int. 2015;2015:191258. doi: 10.1155/2015/191258. Epub 2015 Nov 8.
- Results publication: PubMed 31542332Chang TC, Hsiao SM, Wu PC, Chen CH, Wu WY, Lin HH. Comparison of clinical outcomes between tailored transvaginal mesh surgery and native tissue repair for pelvic organ prolapse. J Formos Med Assoc. 2019 Dec;118(12):1623-1632. doi: 10.1016/j.jfma.2019.08.034. Epub 2019 Sep 18.
- Individual participant dataSharing planned: No. IPD will be shared 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 Lower Urinary Tract Symptoms, 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 2 inclusion and 6 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 22 Sep 2020. 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?
Voiding difficulty (time frame: November 2011 to December 2015). 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 NCT04557852, which also lists 5 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 22 Sep 2020.