TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

Stress Urinary Incontinence Clinical Trial

Official title:

TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00676273
• Other study ID #: 28142
• Status: Unknown status
• Phase: Phase 4
• First received: November 16, 2007
• Last updated: May 12, 2008
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: May 2008
• Source: Boston Urogynecology Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and clinical efficacy in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence.

Description:

Patient satisfaction will be measured by symptom quality of life questionnaires (pre-operatively, 3 months and one year) and patient pain will be measured by verbal analogue rating scale (post-operative day 1 and day 7). Clinical efficacy will be measured by a cough stress test pre-operatively and post-operatively at 3 months and 1 year. A Q-tip test will also be performed pre-operatively and at 3 months and 1 year post-operatively. Subjects will be followed for a minimum of one year to evaluate recurrence of symptoms and complications, including the rate of mesh erosion, time to normal void in the post-operative period, the rate of sling revision, post-operative pain, voiding dysfunction and de novo urgency.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 140
• Est. completion date: December 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are at least 18 years of age

• Demonstrate a positive cough stress test during complex multi-channel urodynamic testing

• Demonstrate impact of stress urinary incontinence on quality of life questionnaire

• Are able to comprehend and sign a written informed consent

• Understand and are willing to comply with the study requirements, including agreeing to be available for the follow-up evaluations

• Are psychologically stable and suitable for interventions determined by the investigator

• Are ambulatory and able to use a toilet independently

Exclusion Criteria:

Patients:

• Who are pregnant or planning to become pregnant during the study or in the future

• With a elevated post-void residual (defined as PVR > 100cc)

• With a bleeding condition or on anti-coagulant therapy

• With immunosuppression (i.e. HIV, lymphoma)

• With multiple sclerosis or other progressive neurological disease

• With evidence of a local or systemic infection, including urinary tract infection

• With evidence of intrinsic sphincter deficiency as defined by a maximal urethral closure pressure of <20 cm H2O

• Previous sub-urethral sling

• Predominant overactive bladder symptoms

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• TVT-Obturator (TVT-O)
sub urethral sling
• TVT-Secur (TVT-S) (Hammock method)
suburethral sling

Locations

Country	Name	City	State
United States	Boston Urogynecology Associates	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Urogynecology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of TVT-S versus TVT-O suburethral slings in the treatment of stress urinary incontinence or the stress incontinence component of mixed urinary incontinence by the presence or absence or urinary incontinence on cough stress test.		1 year
Secondary	To describe or assess known side effects or complications,post-operative pain, time of return to daily activities of living, improvement in patient quality of life, change in Q-tip test		1 year