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

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National Taiwan University

Status

Completed

Conditions

Concomitant Conditions

Treatments

Procedure: The novel anterior TVM surgeries

Study type

Observational

Funder types

Other

Identifiers

NCT03607968
201604022RIND

Details and patient eligibility

About

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

Full 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.

Enrollment

134 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

134 participants in 1 patient group

All women in this study
Description:
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].
Treatment:
Procedure: The novel anterior TVM surgeries

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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