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

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

Study Overview

• Status: Completed
• Conditions: Concomitant Conditions
• Intervention / Treatment: Procedure: The novel anterior TVM surgeries

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.

• Study Type: Observational
• Enrollment (Actual): 134

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All women in this study; 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].

Procedure: The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of urodynamic stress incontinence	Preoperative and postoperative urodynamic studies to detect USI	2011/11/01-2015/12/31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of stress urinary incontinence	Preoperative and postoperative 20-minute pad test changes	2011/11/01-2015/12/31

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: HO-HSIUNG LIN, Professor, Department of Obstetrics and Gynecology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: May 13, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Pelvic organ prolapse; Transvaginal mesh; Urodynamic stress incontinence
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 201604022RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No