Factors Affecting the Improvement of Severity of Concomitant USI After a Novel TVM Surgery for Women With POP
- Conditions
- Concomitant Conditions
- Interventions
- Procedure: The novel anterior TVM surgeries
- Registration Number
- NCT03607968
- Lead Sponsor
- National Taiwan University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 134
- Female
- Diagnosed with pelvic organ prolapse and concomitant overt or occult urodynamic stress incontinence
- Received the novel anterior transvaginal mesh surgery.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All women in this study The novel anterior TVM surgeries 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 \[i.e., 100 \* (postoperative pad weight - baseline pad weight)/baseline pad weight\].
- Primary Outcome Measures
Name Time Method Improvement of urodynamic stress incontinence 2011/11/01-2015/12/31 Preoperative and postoperative urodynamic studies to detect USI
- Secondary Outcome Measures
Name Time Method Improvement of stress urinary incontinence 2011/11/01-2015/12/31 Preoperative and postoperative 20-minute pad test changes