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

July 23, 2018 updated by: National Taiwan University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement of urodynamic stress incontinence
Time Frame: 2011/11/01-2015/12/31
Preoperative and postoperative urodynamic studies to detect USI
2011/11/01-2015/12/31

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement of stress urinary incontinence
Time Frame: 2011/11/01-2015/12/31
Preoperative and postoperative 20-minute pad test changes
2011/11/01-2015/12/31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: HO-HSIUNG LIN, Professor, Department of Obstetrics and Gynecology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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