Mid-term Follow-up for Tailored ATVM

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Procedure: ATVM

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 Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anterior transvaginal mesh group; Women received anterior transvaginal mesh surgery without concomitant mid-urethral sling surgery.	Procedure: ATVM; Tailored anterior transvaginal mesh for pelvic organ prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voiding difficulty	Weak stream of urination, intermittency, strain to void or incomplete empty sensation after the anterior transvaginal mesh surgery	November 2011 to December 2015

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overactive bladder syndrome	Urinary urgency, with or without incontinence, may accompany with urinary frequency and nocturia.	November 2011 to December 2015

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pelvic organ prolapse; Transvaginal mesh; lower urinary tract symptoms; Urodynamic study
• Additional Relevant MeSH Terms: Urological Manifestations; Pathological Conditions, Anatomical; Prolapse; Lower Urinary Tract Symptoms; Pelvic Organ Prolapse
• Other Study ID Numbers: 202006093RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will be shared under reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No