Trials / Completed
CompletedNCT04557852
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 160 (actual)
- Sponsor
- National Taiwan University Hospital · Academic / Other
- Sex
- Female
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ATVM | Tailored anterior transvaginal mesh for pelvic organ prolapse |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2015-12-31
- Completion
- 2015-12-31
- First posted
- 2020-09-22
- Last updated
- 2020-09-22
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04557852. Inclusion in this directory is not an endorsement.