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

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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 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

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
Intervention / Treatment
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

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

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

Medical University of Lublin

Investigators

  • 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)

July 1, 2018

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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