Clinical trial NCT00534365: Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence
Official title: A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
sling procedures
tension-free vaginal tape
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Good Samaritan Hospital, Ohio
name: Greater Baltimore Medical Center
name: Medstar Health Research Institute
name: Duke University
name: Foundation for Female Health Awareness
name: Women and Infants Hospital of Rhode Island
name: Main Line Health
First posted: 2007-09-24
Enrollment: 281
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Urinary incontinence symptoms
* Urodynamic stress incontinence confirmed with multichannel urodynamic testing
* Age of at least 21 years
* Desires surgical correction of stress urinary incontinence

Exclusion Criteria:

* Post-void residual volume \>100cc
* Detrusor overactivity on preoperative multichannel urodynamic testing
* History of previous synthetic, biologic or fascial sub-urethral sling
* Desires future childbearing
* History of bleeding diathesis or current anti-coagulation therapy
* Current genitourinary fistula or urethral diverticulum
* Reversible cause of incontinence (i.e. drug effect)
* Contraindication to surgery

Primary outcomes:
measure: Subjective Cure of Urinary Incontinence at 12 Months After Surgery
timeFrame: 12 months
Secondary outcomes:
measure: Post Operative Complications at 6 Week or Less
timeFrame: 6 week
measure: Long Term Complications > 6 Weeks
timeFrame: 6 weeks-12 months
measure: Patient Global Impression Improvement
timeFrame: 12 months
measure: Incontinence Severity Index Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Paoli
country: United States
facility: Main Line Health
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: The Cleveland Clinic
name: Matthew D Barber, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barber MD, Weidner AC, Sokol AI, Amundsen CL, Jelovsek JE, Karram MM, Ellerkmann M, Rardin CR, Iglesia CB, Toglia M; Foundation for Female Health Awareness Research Network. Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):328-37. doi: 10.1097/AOG.0b013e318242a849.