SECURiTy: Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00534365
• Collaborator: Good Samaritan Hospital, Ohio (Other), Greater Baltimore Medical Center (Other), Medstar Health Research Institute (Other), Duke University (Other), Foundation for Female Health Awareness (Other), Women and Infants Hospital of Rhode Island (Other), Main Line Health (Other)
• Enrollment: 281
• Locations: 7
• Arms: 2
• Duration (Months): 44
• Patients Per Site: 40.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: tension-free vaginal tape; Device: TVT-SECUR device	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 281 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Tension-free vaginal tape procedure (TVT)	Device: tension-free vaginal tape; Retropubic mid-urethral sling; Other Names: TVT
Active Comparator: 2 TVT-SECUR device	Device: TVT-SECUR device; Mid-urethral mini-sling

Outcome Measures

Primary Outcome Measures

1. Subjective Cure of Urinary Incontinence at 12 Months After Surgery [12 months]

   Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.

Secondary Outcome Measures

1. Post Operative Complications at 6 Week or Less [6 week]

2. Long Term Complications > 6 Weeks [6 weeks-12 months]

3. Patient Global Impression Improvement [12 months]

4. Incontinence Severity Index Score [12 months]

   The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Hospital Center	Washington, D.C.	District of Columbia	United States	20010
2	Greater Baltimore Medical Center	Baltimore	Maryland	United States	21204
3	Duke University Medical Center	Durham	North Carolina	United States	27706
4	Good Samaritan Hospital	Cincinnati	Ohio	United States	45520
5	Cleveland Clinic	Cleveland	Ohio	United States	44145
6	Main Line Health	Paoli	Pennsylvania	United States	19301
7	Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

• The Cleveland Clinic
• Good Samaritan Hospital, Ohio
• Greater Baltimore Medical Center
• Medstar Health Research Institute
• Duke University
• Foundation for Female Health Awareness
• Women and Infants Hospital of Rhode Island
• Main Line Health

Investigators

• Principal Investigator: Matthew D Barber, MD, MHS, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00534365
• Other Study ID Numbers: FFHA 07-01
• First Posted: Sep 24, 2007
• Last Update Posted: Jun 9, 2017
• Last Verified: May 1, 2017

• Keywords provided by The Cleveland Clinic: stress urinary incontinence; sling procedures; tension-free vaginal tape
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

Participant Flow

Pre-assignment Detail	A total of 281 patients were enrolled. Of these, 18 patients withdrew prior to randomization (including for the following reasons- cancelled surgery (6), did not meet inclusion criteria (4), declined further participation (8)).

Arm/Group Title	TVT Procedure	TVT-SECUR Mini Sling Procedure
Arm/Group Description	Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling	TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling
Period Title: Overall Study
STARTED	127	136
Received Procedure	127	129
Any Follow up	126	135
Follow up at 12 Months or More	119	128
Included in Intent to Treat Analysis	127	136
COMPLETED	127	129
NOT COMPLETED	0	7

Baseline Characteristics

Arm/Group Title	TVT Procedure	TVT-SECUR Mini Sling Procedure	Total
Arm/Group Description	Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling	TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling	Total of all reporting groups
Overall Participants	127	136	263
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.6 (11.3)	54.6 (10.5)	54.6 (11.0)
Sex/Gender, Customized (participants) [Number]
Female	127 100%	136 100%	263 100%
Race/Ethnicity, Customized (Count of Participants)
White	120 94.5%	118 86.8%	238 90.5%
African American	4 3.1%	12 8.8%	16 6.1%
Other	3 2.4%	6 4.4%	9 3.4%
Region of Enrollment (participants) [Number]
United States	127 100%	136 100%	263 100%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.0 (5.7)	29.6 (6.4)	29.8 (6)

Outcome Measures

1. Primary Outcome

Title	Subjective Cure of Urinary Incontinence at 12 Months After Surgery
Description	Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Analysis based on per protocol enrollment

Arm/Group Title	TVT Procedure	TVT-SECUR Mini Sling Procedure
Arm/Group Description	Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling	TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling
Measure Participants	127	129
Count of Participants [Participants]	77 60.6%	72 52.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TVT Procedure, TVT-SECUR Mini Sling Procedure
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	We chose a non-inferiority margin of 12% based on previously published multicenter trial of mid-urethral slings. Assuming subjective cure rate for TVT of 82%, 127 individuals in each group will provide 80% to reject the null hypothesis that the true difference in cure rates between the two procedures is less than or equal to 2% using a two group large sample normal approximation test of proportions with a one sided 0.05 significance level.
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	Regression, Logistic
	Comments

2. Secondary Outcome

Title	Post Operative Complications at 6 Week or Less
Time Frame	6 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TVT-SECUR Mini Sling Procedure	TVT Procedure
Arm/Group Description	TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling	Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling
Measure Participants	136	127
Post opInfection requiring antibiotics	5 3.9%	6 4.4%
Urinary tract infection	9 7.1%	9 6.6%
Cardiac or MI	0 0%	0 0%
Neurologic	0 0%	0 0%
Pulmonary	0 0%	1 0.7%
Ileus or small bowel obstruction	0 0%	0 0%
Pelvic abscess	0 0%	0 0%
Blood transfusion	1 0.8%	0 0%
Venous thromboembolism	1 0.8%	0 0%
Return to operating room	0 0%	1 0.7%
Hospital readmissions	2 1.6%	2 1.5%
Emergency room evaluations	6 4.7%	5 3.7%
Unplanned clinic visits	24 18.9%	20 14.7%

3. Secondary Outcome

Title	Long Term Complications > 6 Weeks
Time Frame	6 weeks-12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TVT-SECUR Mini Sling Procedure	TVT Procedure
Arm/Group Description	TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling	Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling
Measure Participants	136	127
Infection requiring antibiotics	0 0%	0 0%
Cardiac or myocardial infection	0 0%	0 0%
Neurologic	0 0%	1 0.7%
Pulmonary	0 0%	0 0%
Ileu or small bowel obstruction	0 0%	0 0%
Mesh exposure	0 0%	1 0.7%
Leg pain or difficulty ambulatig	1 0.8%	0 0%
Fistula	0 0%	0 0%

4. Secondary Outcome

Title	Patient Global Impression Improvement
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Please note that no all participants conducted the global improvement scale survey due to loss to follow up.

Arm/Group Title	TVT-SECUR Mini Sling Procedure	TVT Procedure
Arm/Group Description	TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling	Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling
Measure Participants	109	105
Very much better	63 49.6%	67 49.3%
Much better	24 18.9%	24 17.6%
Somewhat better	11 8.7%	9 6.6%
No different	3 2.4%	1 0.7%
Somewhat worse	3 2.4%	3 2.2%
Much worse	2 1.6%	0 0%
Very much worse	3 2.4%	1 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TVT Procedure, TVT-SECUR Mini Sling Procedure
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Incontinence Severity Index Score
Description	The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TVT-SECUR Mini Sling Procedure	TVT Procedure
Arm/Group Description	TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling	Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling
Measure Participants	134	126
Mean (Standard Deviation) [units on a scale]	2.2 (2.7)	1.5 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TVT Procedure, TVT-SECUR Mini Sling Procedure
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Intraoperative complications at time of surgery
Arm/Group Title	TVT-SECUR Mini Sling Procedure		TVT Procedure
Arm/Group Description	TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling		Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling
All Cause Mortality
	TVT-SECUR Mini Sling Procedure		TVT Procedure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	TVT-SECUR Mini Sling Procedure		TVT Procedure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/136 (0%)		0/127 (0%)
Other (Not Including Serious) Adverse Events
	TVT-SECUR Mini Sling Procedure		TVT Procedure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/136 (4.4%)		8/127 (6.3%)
Blood and lymphatic system disorders
Blood transfusion	1/136 (0.7%)	1	0/127 (0%)	0
Injury, poisoning and procedural complications
Bladder injury	1/136 (0.7%)	1	6/127 (4.7%)	6
Ureteral injury	3/136 (2.2%)	3	0/127 (0%)	0
Bowel injury	1/136 (0.7%)	1	2/127 (1.6%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.