Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure

NCT05787730 | Unknown

• 1 other identifier: T283/2022
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Incontinence,Stress

Keywords

TOT; Perineal ultrasound

Outcome Measures

Primary Outcomes (2)

• Subjective cure

  Subjective cure is defined if patient answer to be very satisfied or satisfied with the TOT-procedure

  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)

  15 years after operation

Study Arms (1)

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.

Device: Transobturator tape

Interventions

Transobturator tape DEVICE

Patients operated with TOT

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 28, 2023
• Study Start: January 1, 2005
• Primary Completion: December 31, 2008
• Study Completion: April 1, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share