Impact of Hysterectomy on Quality of Life and Urethral Length

• Conditions: Urethral Diseases; Sex Disorder; Fibroid Uterus
• Interventions: Procedure: urethral length measure

• Registration Number: NCT03757975
• Lead Sponsor: Medical University of Lublin

Brief Summary

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

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 Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• patients qualified to hysterectomy due to benign condition

Exclusion Criteria

• serious health condition
• previous vaginal operations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAH	urethral length measure	patients before and after total abdominal hysterectomy (TAH)
TVH	urethral length measure	patients before and after total vaginal hysterectomy (TVH)
SLH	urethral length measure	patients before and after supracervical laparoscopic hysterectomy (SLH)
SAH	urethral length measure	patients before and after abdominal supracervical hysterectomy (SAH)
TLH	urethral length measure	patients before and after total laparoscopic hysterectomy (TLH)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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.
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

Trial Locations

Locations (1)

2nd Gynecology Department; 🇵🇱 Lublin, Poland