Mid-term Follow-up for Tailored ATVM

Completed

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Procedure: ATVM

• Registration Number: NCT04557852
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study Start: 2011-11-01
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2020-07
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anterior transvaginal mesh group	ATVM	Women received anterior transvaginal mesh surgery without concomitant mid-urethral sling surgery.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overactive bladder syndrome	November 2011 to December 2015	Urinary urgency, with or without incontinence, may accompany with urinary frequency and nocturia.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan