Mid-term Follow-up for Tailored ATVM

NCT ID: NCT04557852

Last Updated: 2020-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-01

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Lower Urinary Tract Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Anterior transvaginal mesh group

Women received anterior transvaginal mesh surgery without concomitant mid-urethral sling surgery.

ATVM

Intervention Type PROCEDURE

Tailored anterior transvaginal mesh for pelvic organ prolapse

Interventions

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ATVM

Tailored anterior transvaginal mesh for pelvic organ prolapse

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women with pelvic organ prolapse
* Women received anterior transvaginal mesh surgery

Exclusion Criteria

* Concomitant mid-urethral sling surgery
* Chronic urinary tract infection
* Interstitial cystitis
* Malignancy history in pelvic organ
* Ever received pelvic radiation
* Concomitant transabdominal surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho-Hsiung Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 19941278 (View on PubMed)

Wu 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.

Reference Type RESULT
PMID: 31844157 (View on PubMed)

Long 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.

Reference Type RESULT
PMID: 32313187 (View on PubMed)

Chang 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.

Reference Type RESULT
PMID: 26634203 (View on PubMed)

Chang 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.

Reference Type RESULT
PMID: 31542332 (View on PubMed)

Other Identifiers

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202006093RIND

Identifier Type: -

Identifier Source: org_study_id

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