Urinary Incontinence,StressNCT05787730
Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure
A study testing Transobturator tape in people with Urinary Incontinence,Stress, run by Turku University Hospital.
Trial summary
The study is a cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- Transobturator tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 Apr 2024
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Has been stress or mixed incontinence, for which surgical treatment has been indicated.
- The cough test must have been positive with a 300 ml bladder filling
- The separation points <7 in the incontinence charts
Who cannot join
- previous incontinence surgery
- simultaneous other gynecological surgery
- residual urine volume >100 ml
- lower urinary tract anomaly
- urinary tract infection
- more than three urinary tract infections per year
Show all 11Show fewer
- more than second-degree gynecological organ deposition
- BMI >35
- previous pelvic radiation therapy or active malignancy.
- Patients with anticoagulant therapy
- hemophilia or neurological disease that could cause bladder dysfunction
About this study
The study is a cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device.
The subjects underwent a urogynecological ultrasound examination before surgery and during the follow-up examination 2-3 months after the procedure. In connection with the follow-up examination, the success of the procedure and the satisfaction of the patients have been evaluated. The data was collected between 2005 and 2008, and the purpose is to invite the patients in question to a research visit, so that the long-term effect of the procedure can be evaluated and the position of the band can be determined with a newer technology ultrasound device. The patients' subjective satisfaction with the procedure is assessed using questionnaires.
Read the detailed description
The study is a retrospective cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device.
The study's inclusion criterion has been stress or mixed incontinence, for which surgical treatment has been indicated. The cough test must have been positive with a 300 ml bladder filling and the separation points <7 in the incontinence charts.. Exclusion criteria included previous incontinence surgery, simultaneous other gynecological surgery, residual urine volume >100 ml, lower urinary tract anomaly, urinary tract infection, more than three urinary tract infections per year, more than second-degree gynecological organ deposition, BMI >35, previous pelvic radiation therapy or active malignancy. Patients with anticoagulant therapy, anticholinergic or duloxetine medication, hemophilia or neurological disease that could cause bladder dysfunction were also not included in the study. Patients who did not understand the importance of research and treatment or who were unable to exercise were also not suitable for the study.
The subjects underwent a urogynecological ultrasound examination before surgery and during the follow-up examination 2-3 months after the procedure. In connection with the follow-up examination, the success of the procedure and the satisfaction of the patients have been evaluated. The data was collected between 2005 and 2008, and the purpose is to invite the patients in question to a research visit, so that the long-term effect of the procedure can be evaluated and the position of the band can be determined with a newer technology ultrasound device. The patients' subjective satisfaction with the procedure is assessed using questionnaires.
The research visit is carried out at Tyks' Gynecology Outpatient Clinic. During the research visit, the subject is subjected to a gynecological clinical examination, which includes a cough test, and a urogynecological ultrasound examination. Prior to the study visit, the subject is provided with written information about the study and questionnaire forms, which the patient brings with her to the study visit. Written consent to the study has been requested from all women participating in the study. Now the subjects will be asked for their consent again. Permission for the research has been requested from the Ethics Committee.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- Transobturator tape
- Keywords
- TOT, Perineal ultrasound
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transobturator tapeDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients operated with TOT | Other | The study is a retrospective cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device. Receives: Device: Transobturator tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective cure
Subjective cure is defined if patient answer to be very satisfied or satisfied with the TOT-procedure
Measured: 15 years after operation
Objective cure
The cough stress test is negative performed in a semilithotomy position with a comfortably filled bladder (200-300 ml)
Measured: 15 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Jan 2005
- Primary completion31 Dec 2008
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787730
- Sponsor's protocol ID
- T283/2022
- Status last verified
- Dec 2023
- First submitted
- 20 Feb 2023
- Last updated
- 26 Dec 2023
- Results posted
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure
- ClinicalTrials.gov ID
- NCT05787730
- Acronym / sponsor ID
- T283/2022
- Conditions
- Urinary Incontinence,Stress
- Keywords
- TOT, Perineal ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 28 Mar 2023 (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.
The study is a cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device.
The subjects underwent a urogynecological ultrasound examination before surgery and during the follow-up examination 2-3 months after the procedure. In connection with the follow-up examination, the success of the procedure and the satisfaction of the patients have been evaluated. The data was collected between 2005 and 2008, and the purpose is to invite the patients in question to a research visit, so that the long-term effect of the procedure can be evaluated and the position of the band can be determined with a newer technology ultrasound device. The patients' subjective satisfaction with the procedure is assessed using questionnaires.
Detailed description
The study is a retrospective cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device.
The study's inclusion criterion has been stress or mixed incontinence, for which surgical treatment has been indicated. The cough test must have been positive with a 300 ml bladder filling and the separation points <7 in the incontinence charts.. Exclusion criteria included previous incontinence surgery, simultaneous other gynecological surgery, residual urine volume >100 ml, lower urinary tract anomaly, urinary tract infection, more than three urinary tract infections per year, more than second-degree gynecological organ deposition, BMI >35, previous pelvic radiation therapy or active malignancy. Patients with anticoagulant therapy, anticholinergic or duloxetine medication, hemophilia or neurological disease that could cause bladder dysfunction were also not included in the study. Patients who did not understand the importance of research and treatment or who were unable to exercise were also not suitable for the study.
The subjects underwent a urogynecological ultrasound examination before surgery and during the follow-up examination 2-3 months after the procedure. In connection with the follow-up examination, the success of the procedure and the satisfaction of the patients have been evaluated. The data was collected between 2005 and 2008, and the purpose is to invite the patients in question to a research visit, so that the long-term effect of the procedure can be evaluated and the position of the band can be determined with a newer technology ultrasound device. The patients' subjective satisfaction with the procedure is assessed using questionnaires.
The research visit is carried out at Tyks' Gynecology Outpatient Clinic. During the research visit, the subject is subjected to a gynecological clinical examination, which includes a cough test, and a urogynecological ultrasound examination. Prior to the study visit, the subject is provided with written information about the study and questionnaire forms, which the patient brings with her to the study visit. Written consent to the study has been requested from all women participating in the study. Now the subjects will be asked for their consent again. Permission for the research has been requested from the Ethics Committee.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients operated with TOT | Other | Device: Transobturator tapeThe study is a retrospective cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Has been stress or mixed incontinence, for which surgical treatment has been indicated.
- The cough test must have been positive with a 300 ml bladder filling
- The separation points <7 in the incontinence charts
Key exclusion criteria (11 listed)
- previous incontinence surgery
- simultaneous other gynecological surgery
- residual urine volume >100 ml
- lower urinary tract anomaly
- urinary tract infection
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 |
|---|---|---|
| Transobturator tape | Device | Patients operated with TOT |
Primary outcome
Subjective cure
Time frame: 15 years after operation
Subjective cure is defined if patient answer to be very satisfied or satisfied with the TOT-procedure
Objective cure
Time frame: 15 years after operation
The cough stress test is negative performed in a semilithotomy position with a comfortably filled bladder (200-300 ml)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transobturator tape in people with Urinary Incontinence,Stress, run by Turku University Hospital.
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 3 inclusion and 11 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 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Subjective cure (time frame: 15 years after operation). The study lists 2 primary outcomes in all. 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 26 Dec 2023.