Tension-free Vaginal Tape Obturator for the Treatment of Urinary Incontinence -Long-term Follow-up

NCT04240613 | Completed

• 1 other identifier: 13533
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

The efficacy of TVT-O (tension-free vaginal tape obturator) is well established in patients with stress urinary incontinence (SUI). The objective of this study was to evaluate the efficacy, safety and patient satisfaction of TVT-O in patients suffering from primary, mixed (MUI) or recurrent urinary incontinence (UI) in long-term follow-up.

Conditions

Urinary Incontinence,Stress; Urinary Incontinence, Urge

Keywords

TVT-O; long-term follow-up; retrospective

Outcome Measures

Primary Outcomes (1)

• objective and subjective treatment success

  Objective treatment success was a negative cough stress test (CST), The CST was performed with a bladder volume of 300 ml aiming on adjusting the tape to allow a drop of saline to escape from the outer meatus of the urethra on strong coughing. The patient was subjectively cured if she answered to being very satisfied or satisfied with the operation.

  9.25 years

Study Arms (1)

women treated by TVT-O

OTHER

All women treated by TVT-O during the years this study was made were included.

Device: TVT-O

Interventions

TVT-O DEVICE

TVT-O is one of the most popular treatments for urinary incontinence (UI). Its efficacy is well established in patients with pure stress urinary incontinence (SUI). Data reporting long-term outcomes of TVT-O for the treatment of mixed urinary incontinence (MUI) or recurrent SUI is scarce. The objective of this study was to evaluate the efficacy and safety and overall patient satisfaction of TVT-O in different subgroups of UI in a long-term follow-up.

women treated by TVT-O

Eligibility Criteria

• Gender Eligibility Details: TVT-O is only for females, to treat female urinary incontinence.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• We included all the patients who underwent the TVT-O operation between August 2004 and October 2011 in our hospital, Turku university hospital Finland.

Sponsors & Collaborators

• Turku University Hospital: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge

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

Study Officials

• Eija Laurikainen

  Turku University Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2017
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share