Impact of Hysterectomy on Quality of Life and Urethral Length

NCT03757975 | Unknown

• 1 other identifier: 012018
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibroid Uterus; Urethral Diseases; Sex Disorder

Keywords

quality of life; urethral length; sexual function

Outcome Measures

Primary Outcomes (1)

• Change from Baseline urethral length at 6 months after hysterectomy

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

  6 months

Secondary Outcomes (4)

• Change from Baseline in sexual functions at 6 months after hysterectomy

  6 months

• Change from Baseline in appearance of urinary incontinence at 6 months after hysterectomy

  6 months

• Change from Baseline in impact of urinary incontinence at 6 months after hysterectomy

  6 months

• Change from Baseline in urinary tract symptoms at 6 months after hysterectomy

  6 months

Study Arms (5)

TAH

patients before and after total abdominal hysterectomy (TAH)

Procedure: urethral length measure

TLH

patients before and after total laparoscopic hysterectomy (TLH)

Procedure: urethral length measure

TVH

patients before and after total vaginal hysterectomy (TVH)

Procedure: urethral length measure

SAH

patients before and after abdominal supracervical hysterectomy (SAH)

Procedure: urethral length measure

SLH

patients before and after supracervical laparoscopic hysterectomy (SLH)

Procedure: urethral length measure

Interventions

urethral length measure PROCEDURE

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

Also known as: UDI 6 and IIQ 7 questionnaires, FSFI questionnaire, ICIQ questionnaire

SAH; SLH; TAH; TLH; TVH

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patients qualified to hysterectomy due to benign condition

You may not qualify if:

• serious health condition
• previous vaginal operations

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

2nd Gynecology Department

Lublin, 20-954, Poland

RECRUITING

MeSH Terms

Conditions

Leiomyoma; Urethral Diseases; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases

Study Officials

• Tomasz Rechberger, Professor

  Medical University of Lublin

  STUDY DIRECTOR

Central Study Contacts

Katarzyna A. Skorupska, PhD

CONTACT

0048604418512; kasiaperzylo@hotmail.com

Pawel Miotla, PhD

CONTACT

0048604793902; pmiotla@wp.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 29, 2018
• Study Start: July 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: May 1, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)