Mid-term Follow-up for Tailored ATVM

NCT04557852 | Completed

• 1 other identifier: 202006093RIND
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Pelvic organ prolapse; Transvaginal mesh; lower urinary tract symptoms; Urodynamic study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overactive bladder syndrome

  November 2011 to December 2015

Study Arms (1)

Anterior transvaginal mesh group

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

Procedure: ATVM

Interventions

ATVM PROCEDURE

Tailored anterior transvaginal mesh for pelvic organ prolapse

Anterior transvaginal mesh group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 19941278 RESULT

• 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.

  PMID: 31844157 RESULT

• 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.

  PMID: 32313187 RESULT

• 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.

  PMID: 26634203 RESULT

• 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.

  PMID: 31542332 RESULT

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Ho-Hsiung Lin, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 22, 2020
• Study Start: November 1, 2011
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: September 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)