Clinical trial NCT03607968: Factors Affecting the Improvement of Severity of Concomitant USI After a Novel TVM Surgery for Women With POP
Official title: Factors Affecting the Improvement of Severity of Concomitant Urodynamic Stress Incontinence After a Novel Transvaginal Mesh Surgery for Women With Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concomitant Conditions
Keywords: Pelvic organ prolapse
Transvaginal mesh
Urodynamic stress incontinence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 134
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries, were enrolled in this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of urodynamic stress incontinence
timeFrame: 2011/11/01-2015/12/31
Secondary outcomes:
measure: Improvement of stress urinary incontinence
timeFrame: 2011/11/01-2015/12/31
Other outcomes:
Locations:
Study officials:
affiliation: Department of Obstetrics and Gynecology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
name: HO-HSIUNG LIN, Professor
role: PRINCIPAL_INVESTIGATOR
References: