Fibroid UterusNCT03757975
Impact of Hysterectomy on Quality of Life and Urethral Length
An observational study of Fibroid Uterus and Urethral Diseases, run by Medical University of Lublin at 1 site in Poland.
Trial summary
To establish the impact of hysterectomy on sexual function, urethral length and quality of life Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibroid Uterus, Urethral Diseases, Sex Disorder
- What is being tested?
- urethral length measure
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2018to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients qualified to hysterectomy due to benign condition
Who cannot join
- serious health condition
- previous vaginal operations
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
2nd Gynecology Department
Lublin, 20-954
katarzyna A. skorupska, PhD, 0048604418512, kasiaperzylo@hotmail.com
Pawel Miotla, PhD, 0048604793902, pmiotla@wp.pl
About this study
Official title: Impact of Hysterectomy and Supracervical Hysterectomy on Quality of Life, Urinary Incontinence and Urethral Length
To establish the impact of hysterectomy on sexual function, urethral length and quality of life
Read the 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.
- Conditions
- Fibroid Uterus, Urethral Diseases, Sex Disorder
- Being tested
- urethral length measure
- Keywords
- quality of life, urethral length, sexual function
- Medical subject headings
- Leiomyoma, Urethral Diseases, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urethral length measureProcedure or surgery
Also called UDI 6 and IIQ 7 questionnaires, FSFI questionnaire, ICIQ questionnaire
measure of urethral length, distribution of questionnaires before and after operation
| Study group | Role | What they receive |
|---|---|---|
| TAH | patients before and after total abdominal hysterectomy (TAH) Receives: Procedure: urethral length measure | |
| TLH | patients before and after total laparoscopic hysterectomy (TLH) Receives: Procedure: urethral length measure | |
| TVH | patients before and after total vaginal hysterectomy (TVH) Receives: Procedure: urethral length measure | |
| SAH | patients before and after abdominal supracervical hysterectomy (SAH) Receives: Procedure: urethral length measure | |
| SLH | patients before and after supracervical laparoscopic hysterectomy (SLH) Receives: Procedure: urethral length measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Jul 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Miotła, Medical University of Lublin
- Investigators
- Tomasz Rechberger, Professor, Study director, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757975
- Sponsor's protocol ID
- 012018
- Status last verified
- Feb 2020
- First submitted
- 19 Nov 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hysterectomy and Supracervical Hysterectomy on Quality of Life, Urinary Incontinence and Urethral Length
- ClinicalTrials.gov ID
- NCT03757975
- Acronym / sponsor ID
- 012018
- Conditions
- Fibroid Uterus, Urethral Diseases, Sex Disorder
- Keywords
- quality of life, urethral length, sexual function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TAH | – | Procedure: urethral length measurepatients before and after total abdominal hysterectomy (TAH) |
| TLH | – | Procedure: urethral length measurepatients before and after total laparoscopic hysterectomy (TLH) |
| TVH | – | Procedure: urethral length measurepatients before and after total vaginal hysterectomy (TVH) |
| SAH | – | Procedure: urethral length measurepatients before and after abdominal supracervical hysterectomy (SAH) |
| SLH | – | Procedure: urethral length measurepatients before and after supracervical laparoscopic hysterectomy (SLH) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients qualified to hysterectomy due to benign condition
Key exclusion criteria (2 listed)
- serious health condition
- previous vaginal operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urethral length measureAlso: UDI 6 and IIQ 7 questionnaires, FSFI questionnaire, ICIQ questionnairemeasure of urethral length, distribution of questionnaires before and after operation | Procedure or surgery | SAH, SLH, TAH, TLH, TVH |
Primary outcome
Change from Baseline urethral length at 6 months after hysterectomy
Time frame: 6 months
Comparison of urethral length before and after hysterectomy. Urethra will be measured during ultrasound examination in millimeters
4 secondary outcomes
Change from Baseline in sexual functions at 6 months after hysterectomy
Time frame: 6 months
Change from Baseline in appearance of urinary incontinence at 6 months after hysterectomy
Time frame: 6 months
Change from Baseline in impact of urinary incontinence at 6 months after hysterectomy
Time frame: 6 months
Change from Baseline in urinary tract symptoms at 6 months after hysterectomy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Fibroid Uterus
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Rechberger, Professor study director
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibroid Uterus and Urethral Diseases, run by Medical University of Lublin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna A. Skorupska, PhD (0048604418512, kasiaperzylo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline urethral length at 6 months after hysterectomy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.