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NCT03757975 Clinical Trial

Impact of Hysterectomy on Quality of Life and Urethral Length

Fibroid Uterus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03757975
Other study ID # 012018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date May 1, 2020

Study information
Verified date February 2020
Source Medical University of Lublin
Contact Katarzyna A. Skorupska, PhD
Phone 0048604418512
Email kasiaperzylo@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date May 1, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patients qualified to hysterectomy due to benign condition

Exclusion Criteria:

- serious health condition

- previous vaginal operations

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• urethral length measure
measure of urethral length, distribution of questionnaires before and after operation

Locations
Country Name City State
Poland 2nd Gynecology Department Lublin

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

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