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Factors Affecting the Improvement of Severity of Concomitant USI After a Novel TVM Surgery for Women With POP

Factors Affecting the Improvement of Severity of Concomitant Urodynamic Stress Incontinence After a Novel Transvaginal Mesh Surgery for Women With Pelvic Organ Prolapse

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03607968
Enrollment
134
Registered
2018-07-31
Start date
2011-11-01
Completion date
2015-12-31
Last updated
2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concomitant Conditions

Keywords

Pelvic organ prolapse, Transvaginal mesh, Urodynamic stress incontinence

Brief summary

Background/Purpose: A novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery. Patients and Methods: All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline \[i.e., 100 \* (postoperative pad weight - baseline pad weight)/baseline pad weight\]. Expected Results: The investigators will get the factors responsible for anti-incontinence effect of this novel anterior TVM surgery. Key Words: pelvic organ prolapse, stress urinary incontinence, pad test, urodynamic stress incontinence

Detailed description

Background/Purpose: A novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery. Methods: All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries between November 2011 and December 2015 at the Department of Obstetrics & Gynecology, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline \[i.e., 100 \* (postoperative pad weight - baseline pad weight)/baseline pad weight\]. Expected Results: The investigators will get the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.

Interventions

PROCEDUREThe novel anterior TVM surgeries

A novel transvaginal mesh (TVM) surgery fro women with pelvic organ prolapse (POP) had been reported. 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 http;//dx.doi.org/10.1155/2015/191258.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female * Diagnosed with pelvic organ prolapse and concomitant overt or occult urodynamic stress incontinence * Received the novel anterior transvaginal mesh surgery.

Exclusion criteria

* Pregnant women, prepare for pregnancy or younger than 20-year-old * Significant severe urinary urgency * Mixed urinary incontinence with dominant urgency incontinence * Regular urethral catheterization or intermittent self-catheterization * Urinary tract infection (UTI) or chronic inflammation in recent 2 weeks before operation * Bladder calculus * A history of pelvic radiotherapy * Preexisting malignant pelvic tumors.

Design outcomes

Primary

MeasureTime frameDescription
Improvement of urodynamic stress incontinence2011/11/01-2015/12/31Preoperative and postoperative urodynamic studies to detect USI

Secondary

MeasureTime frameDescription
Improvement of stress urinary incontinence2011/11/01-2015/12/31Preoperative and postoperative 20-minute pad test changes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026