Impact of Hysterectomy on Quality of Life and Urethral Length

February 18, 2020 updated by: Paweł Miotła, Medical University of Lublin

Impact of Hysterectomy and Supracervical Hysterectomy on Quality of Life, Urinary Incontinence and Urethral Length

To establish the impact of hysterectomy on sexual function, urethral length and quality of life

Study Overview

Status

Status

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

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

The investigators evaluate impact of total hysterectomy (abdominal, by laparoscopy and vaginal) and supracervical hysterectomy (abdominal and by laparoscopy) on quality of life, sexual function, urethral length and urinary incontinence. The patients fulfill questionnaires (UDI 6, IIQ7, FSFI and ICIQ) before operation and 6 months after. Additionally the investigators measure urethral length before procedure and 6 months after.

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 (Anticipated)

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.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Pawel Miotla, PhD
  • Phone Number: 0048604793902
  • Email: pmiotla@wp.pl

Study Locations

  • Poland
      • Lublin, Poland, 20-954
        • Recruiting
        • 2nd Gynecology Department
        • Contact:
        • Contact:
          • Pawel Miotla, PhD
          • Phone Number: 0048604793902
          • Email: pmiotla@wp.pl
        • Sub-Investigator:
          • Sara Wawrysiuk, MD

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women who have been qualified to hysterectomy due to fibroids or other benign cndition and who had not undergone any vaginal operation in the past

Description

Inclusion Criteria:

  • patients qualified to hysterectomy due to benign condition

Exclusion Criteria:

  • serious health condition
  • previous vaginal operations

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.
TAH
patients before and after total abdominal hysterectomy (TAH)
Procedure: urethral length measure
measure of urethral length, distribution of questionnaires before and after operation
Other Names:
  • UDI 6 and IIQ 7 questionnaires
  • FSFI questionnaire
  • ICIQ questionnaire
TLH
patients before and after total laparoscopic hysterectomy (TLH)
Procedure: urethral length measure
measure of urethral length, distribution of questionnaires before and after operation
Other Names:
  • UDI 6 and IIQ 7 questionnaires
  • FSFI questionnaire
  • ICIQ questionnaire
TVH
patients before and after total vaginal hysterectomy (TVH)
Procedure: urethral length measure
measure of urethral length, distribution of questionnaires before and after operation
Other Names:
  • UDI 6 and IIQ 7 questionnaires
  • FSFI questionnaire
  • ICIQ questionnaire
SAH
patients before and after abdominal supracervical hysterectomy (SAH)
Procedure: urethral length measure
measure of urethral length, distribution of questionnaires before and after operation
Other Names:
  • UDI 6 and IIQ 7 questionnaires
  • FSFI questionnaire
  • ICIQ questionnaire
SLH
patients before and after supracervical laparoscopic hysterectomy (SLH)
Procedure: urethral length measure
measure of urethral length, distribution of questionnaires before and after operation
Other Names:
  • UDI 6 and IIQ 7 questionnaires
  • FSFI questionnaire
  • ICIQ questionnaire

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
Change from Baseline urethral length at 6 months after hysterectomy
Time Frame: 6 months
Comparison of urethral length before and after hysterectomy. Urethra will be measured during ultrasound examination in millimeters
6 months

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
Change from Baseline in sexual functions at 6 months after hysterectomy
Time Frame: 6 months
The patients fulfill FSFI questionnaire before and after hysterectomy. Range 2-36 with higher scores indicating better sexual function.
6 months
Change from Baseline in appearance of urinary incontinence at 6 months after hysterectomy
Time Frame: 6 months
The patients fulfill UDI 6 (range 0-400) questionnaire to assess appearance of urinary incontinence before and after hysterectomy
6 months
Change from Baseline in impact of urinary incontinence at 6 months after hysterectomy
Time Frame: 6 months
The patients fulfill IIQ 7 (range 0-400) questionnaire to assess impact of hysterectomy on urinary incontinence.
6 months
Change from Baseline in urinary tract symptoms at 6 months after hysterectomy
Time Frame: 6 months
The patients fulfill ICIQ questionnaire to assess impact of hysterectomy on urinary tract symptoms
6 months

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.
Medical University of Lublin

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.
  • Study Director: Tomasz Rechberger, Professor, Medical University of Lublin

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.
July 1, 2018

Primary Completion (Anticipated)

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.
April 30, 2020

Study Completion (Anticipated)

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.
May 1, 2020

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).
November 19, 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.
November 28, 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.
November 29, 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.
February 19, 2020

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.
February 18, 2020

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.
February 1, 2020

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.
  • 012018 (The Alfred Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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