Stress Urinary IncontinenceNCT03800615
Iatrogenic Impairment of Urethral Coitus Owing to Midurethral Sling Procedure in a Woman With Vaginal Agenesis.
An observational study of Stress Urinary Incontinence and Vaginal Agenesis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To report a case of impairment urethral coitus after the midurethral sling procedure Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Vaginal Agenesis
- What is being tested?
- Cut the sling
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jan 2019to 1 Feb 2019
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A 59-year-old woman had previous history of hysterectomy due to nonfunctional uterine obstruction at 19 years old and urinary incontinence status post transvaginal tape procedure at 45 years old with clinical symptoms of difficulty in urethral coitus after midurethral sling procedure.
Who may be able to join
- midurethral sling procedure for stress urinary incontinence
- woman with vaginal agenesis.
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
To report a case of impairment urethral coitus after the midurethral sling procedure
Read the detailed description
To report a case of impairment urethral coitus after the midurethral sling procedure.
- Conditions
- Stress Urinary Incontinence, Vaginal Agenesis
- Being tested
- Cut the sling
- Medical subject headings
- Urinary Incontinence, Stress, Vagina, absence of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cut the slingProcedure or surgery
Cut the mid-urethral sling for stress urinary incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual function
Asking the patient whether she can resume sexual intercourse or not after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start9 Jan 2019
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies 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
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800615
- Sponsor's protocol ID
- 107183-C
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 8 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iatrogenic Impairment of Urethral Coitus Owing to Midurethral Sling Procedure in a Woman With Vaginal Agenesis.
- ClinicalTrials.gov ID
- NCT03800615
- Acronym / sponsor ID
- 107183-C
- Conditions
- Stress Urinary Incontinence, Vaginal Agenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 11 Jan 2019 (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 report a case of impairment urethral coitus after the midurethral sling procedure
Detailed description
To report a case of impairment urethral coitus after the midurethral sling procedure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A 59-year-old woman had previous history of hysterectomy due to nonfunctional uterine obstruction at 19 years old and urinary incontinence status post transvaginal tape procedure at 45 years old with clinical symptoms of difficulty in urethral coitus after midurethral sling procedure.
Key inclusion criteria (2 listed)
- midurethral sling procedure for stress urinary incontinence
- woman with vaginal agenesis.
Key exclusion criteria (1 listed)
- Nil
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 |
|---|---|---|
| Cut the slingCut the mid-urethral sling for stress urinary incontinence | Procedure or surgery | – |
Primary outcome
Sexual function
Time frame: 1 year
Asking the patient whether she can resume sexual intercourse or not after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stress Urinary Incontinence and Vaginal Agenesis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 8 Mar 2019. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual function (time frame: 1 year). 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 8 Mar 2019.