Clinical trial NCT05787730: Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure
Official title: Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Incontinence,Stress
Keywords: TOT
Perineal ultrasound
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-28
Enrollment: 54
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* hemophilia or neurological disease that could cause bladder dysfunction

Primary outcomes:
measure: Subjective cure
timeFrame: 15 years after operation
measure: Objective cure
timeFrame: 15 years after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: