Impact of Hysterectomy on Quality of Life and Urethral Length

NCT ID: NCT03757975

Last Updated: 2020-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Fibroid Uterus Urethral Diseases Sex Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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TAH

patients before and after total abdominal hysterectomy (TAH)

urethral length measure

Intervention Type PROCEDURE

measure of urethral length, distribution of questionnaires before and after operation

TLH

patients before and after total laparoscopic hysterectomy (TLH)

urethral length measure

Intervention Type PROCEDURE

measure of urethral length, distribution of questionnaires before and after operation

TVH

patients before and after total vaginal hysterectomy (TVH)

urethral length measure

Intervention Type PROCEDURE

measure of urethral length, distribution of questionnaires before and after operation

SAH

patients before and after abdominal supracervical hysterectomy (SAH)

urethral length measure

Intervention Type PROCEDURE

measure of urethral length, distribution of questionnaires before and after operation

SLH

patients before and after supracervical laparoscopic hysterectomy (SLH)

urethral length measure

Intervention Type PROCEDURE

measure of urethral length, distribution of questionnaires before and after operation

Interventions

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urethral length measure

measure of urethral length, distribution of questionnaires before and after operation

Intervention Type PROCEDURE

Other Intervention Names

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UDI 6 and IIQ 7 questionnaires FSFI questionnaire ICIQ questionnaire

Eligibility Criteria

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Inclusion Criteria

* patients qualified to hysterectomy due to benign condition

Exclusion Criteria

* serious health condition
* previous vaginal operations
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Paweł Miotła

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomasz Rechberger, Professor

Role: STUDY_DIRECTOR

Medical University of Lublin

Locations

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2nd Gynecology Department

Lublin, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Katarzyna A. Skorupska, PhD

Role: CONTACT

0048604418512

Pawel Miotla, PhD

Role: CONTACT

0048604793902

Facility Contacts

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katarzyna A. skorupska, PhD

Role: primary

0048604418512

Pawel Miotla, PhD

Role: backup

0048604793902

Other Identifiers

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012018

Identifier Type: -

Identifier Source: org_study_id

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