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

Phase 4

• Conditions: Stress Urinary Incontinence
• Interventions: Device: TVT-Obturator (TVT-O); Device: TVT-Secur (TVT-S) (Hammock method)

• Registration Number: NCT00676273
• Lead Sponsor: Boston Urogynecology Associates

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-11-16
• Status Verified: 2008-05
• Study First Submitted QC: 2008-05-12
• Last Update Submitted: 2008-05-12
• Study First Posted: 2008-05-13
• Last Update Posted: 2008-05-13
• Primary Completion: 2009-03
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TVT-Obturator (TVT-O)	TVTO
2	TVT-Secur (TVT-S) (Hammock method)	TVTS

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Boston Urogynecology Associates; 🇺🇸 Cambridge, Massachusetts, United States