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Impact of Hysterectomy on Quality of Life and Urethral Length

Sponsor
Medical University of Lublin (Other)
Overall Status
Unknown status
CT.gov ID
NCT03757975
Collaborator
(none)
500
Enrollment
1
Location
22
Anticipated Duration (Months)
22.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: urethral length measure

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Impact of Hysterectomy and Supracervical Hysterectomy on Quality of Life, Urinary Incontinence and Urethral Length
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Apr 30, 2020
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline urethral length at 6 months after hysterectomy [6 months]

      Comparison of urethral length before and after hysterectomy. Urethra will be measured during ultrasound examination in millimeters

    Secondary Outcome Measures

    1. Change from Baseline in sexual functions at 6 months after hysterectomy [6 months]

      The patients fulfill FSFI questionnaire before and after hysterectomy. Range 2-36 with higher scores indicating better sexual function.

    2. Change from Baseline in appearance of urinary incontinence at 6 months after hysterectomy [6 months]

      The patients fulfill UDI 6 (range 0-400) questionnaire to assess appearance of urinary incontinence before and after hysterectomy

    3. Change from Baseline in impact of urinary incontinence at 6 months after hysterectomy [6 months]

      The patients fulfill IIQ 7 (range 0-400) questionnaire to assess impact of hysterectomy on urinary incontinence.

    4. Change from Baseline in urinary tract symptoms at 6 months after hysterectomy [6 months]

      The patients fulfill ICIQ questionnaire to assess impact of hysterectomy on urinary tract symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients qualified to hysterectomy due to benign condition
    Exclusion Criteria:

    • serious health condition

    • previous vaginal operations

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 2nd Gynecology Department Lublin Poland 20-954

    Sponsors and Collaborators

    • Medical University of Lublin

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paweł Miotła, Clinical Professor, Medical University of Lublin
    ClinicalTrials.gov Identifier:
    NCT03757975
    Other Study ID Numbers:
    • 012018
    First Posted:
    Nov 29, 2018
    Last Update Posted:
    Feb 19, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Paweł Miotła, Clinical Professor, Medical University of Lublin
    quality of life
    urethral length
    sexual function
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Urethral Diseases
    Sexual Dysfunction, Physiological

    Study Results

    No Results Posted as of Feb 19, 2020