TOMUS-Trial Of Mid-Urethral Slings

• Sponsor: HealthCore-NERI (Other)
• Overall Status: Completed
• CT.gov ID: NCT00325039
• Collaborator: (none)
• Enrollment: 597
• Locations: 11
• Arms: 2
• Duration (Months): 86
• Patients Per Site: 54.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Procedure: retropubic mid-urethral sling (TVT); Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 597 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TOMUS-Trial Of Mid-Urethral Slings
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)	Procedure: retropubic mid-urethral sling (TVT); This trial is a comparison of two types of mid-urethral slings. The retropubic mid-urethral mesh sling is used for treatment of stress incontinence; this procedure was less invasive than the fascial sling procedures that were reference standards at the start of the study. Specifically, a synthetic tape is passed transvaginally at the midurethral level through the retropubic space.
Active Comparator: 2 transobturator mid-urethral sling (TVT-O and the Monarc) Two transobturator slings were used: the Tension-free Vaginal Tape Obturator (Gynecare), which is placed starting inside the vagina and coming out through the obturator foramen ("in-to-out") or the Monarc (American Medical System), which is placed starting in the groin area, passing through the obturator foramen, and then into the vagina ("out-to-in").	Procedure: transobturator mid-urethral sling (TVT-O and the Monarc); This trial is a comparison of two types of mid-urethral slings. The transobturator mid-urethral sling is used for treatment of stress incontinence; this procedure was developed to minimize the potential for bladder and bowel injuries associated with the retropubic sling, since the sling is passed through the obturator canal, avoiding the pelvic organs in the retropubic space.

Outcome Measures

Primary Outcome Measures

1. Objective Treatment Success at 12 Months [12 months]

   Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is <15g/24 hrs.

2. Subjective Treatment Success at 12 Months [12 months]

   Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.

Secondary Outcome Measures

1. Patient Satisfaction at 12 Months [Follow-Up]

   Patient satisfaction was assessed at the 12 month visit with the questions, "how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage?" Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as "satisfied" and neutral, most dissatisfied and completely dissatisfied as "not satisfied".

2. Change in Quality of Life From Baseline to 12 Months [Baseline - 12 months]

   Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).

3. Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months [12 months]

   Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Female

• Stress urinary incontinence (SUI) as evidenced by all of the following:

• Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months

• Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)

• Observation of leakage by provocative stress test at a bladder volume ≤ 300ml

• Bladder capacity ≥ 200ml by stress test

• Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower. If POP is Stage II-IV, PVR >100cc but ≤ 500cc is allowed

• Eligible for both retropubic and transobturator procedures

• No medical contraindications, e.g., current urinary tract infection (UTI), history of pelvic irradiation, history of lower urinary tract cancer

• American Society of Anesthesiologists (ASA) class I, II, or III

• No current intermittent catheterization

• Available for 24-months of follow-up and able to complete study assessments, per clinician judgment

• Signed consent form

Exclusion Criteria:

• Age <21 years

• Non-ambulatory (ambulatory with assistive devices does not exclude the patient)

• Pregnancy by self-report or positive pregnancy test, or self-reported intention to ever become pregnant

• Current chemotherapy or current or history of pelvic radiation therapy

• Systemic disease known to affect bladder function (i.e., Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma)

• Urethral diverticulum, current or previous (i.e. repaired)

• Prior augmentation cystoplasty or artificial sphincter

• Implanted nerve stimulators for urinary symptoms

• History of synthetic sling for stress urinary incontinence

• <12 months post-partum

• Laparoscopic or open pelvic surgery <3 months*

• Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome)

• Participation in another treatment intervention trial that might influence the results of this trial

• Need for concomitant surgery requiring an abdominal incision, use of graft material in the anterior compartment, or any use of synthetic graft material

• Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or BE-DRI/E-BE-DRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	University of California	San Diego	California	United States	92103
3	Kaiser Permanente	San Diego	California	United States	92110
4	Loyola University Medical Center	Maywood	Illinois	United States	60153
5	University of Maryland	Baltimore	Maryland	United States	21201
6	Oakwood Hospital/Cancer Center	Dearborn	Michigan	United States	48123
7	William Beaumont Hospital	Royal Oak	Michigan	United States	48123
8	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
9	University of Texas Southwestern	Dallas	Texas	United States	75390
10	University of Texas Health Sciences Center	San Antonio	Texas	United States	78229-3900
11	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• HealthCore-NERI

Investigators

• Study Chair: Ann Gormley, M.D., Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Urinary Incontinence Treatment Network Public Website

Publications

• Brubaker L, Norton PA, Albo ME, Chai TC, Dandreo KJ, Lloyd KL, Lowder JL, Sirls LT, Lemack GE, Arisco AM, Xu Y, Kusek JW; Urinary Incontinence Treatment Network. Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study. Am J Obstet Gynecol. 2011 Nov;205(5):498.e1-6. doi: 10.1016/j.ajog.2011.07.011. Epub 2011 Jul 20.
• Chai TC, Huang L, Kenton K, Richter HE, Baker J, Kraus S, Litman H; Urinary Incontinence Treatment Network (UITN). Association of baseline urodynamic measures of urethral function with clinical, demographic, and other urodynamic variables in women prior to undergoing midurethral sling surgery. Neurourol Urodyn. 2012 Apr;31(4):496-501. doi: 10.1002/nau.21198. Epub 2012 Feb 29.
• Chai TC, Kenton K, Xu Y, Sirls L, Zyczynski H, Wilson TS, Rahn DD, Whitcomb EL, Hsu Y, Gormley EA. Effects of concomitant surgeries during midurethral slings (MUS) on postoperative complications, voiding dysfunction, continence outcomes, and urodynamic variables. Urology. 2012 Jun;79(6):1256-61. doi: 10.1016/j.urology.2012.02.048. Epub 2012 Apr 25.
• Nager CW, Sirls L, Litman HJ, Richter H, Nygaard I, Chai T, Kraus S, Zyczynski H, Kenton K, Huang L, Kusek J, Lemack G; Urinary Incontinence Treatment Network. Baseline urodynamic predictors of treatment failure 1 year after mid urethral sling surgery. J Urol. 2011 Aug;186(2):597-603. doi: 10.1016/j.juro.2011.03.105. Epub 2011 Jun 16.
• Nygaard I, Brubaker L, Chai TC, Markland AD, Menefee SA, Sirls L, Sutkin G, Zimmern P, Arisco A, Huang L, Tennstedt S, Stoddard A. Risk factors for urinary tract infection following incontinence surgery. Int Urogynecol J. 2011 Oct;22(10):1255-65. doi: 10.1007/s00192-011-1429-9. Epub 2011 May 11.
• Richter HE, Litman HJ, Lukacz ES, Sirls LT, Rickey L, Norton P, Lemack GE, Kraus S, Moalli P, Fitzgerald MP, Dandreo KJ, Huang L, Kusek JW; Urinary Incontinence Treatment Network. Demographic and clinical predictors of treatment failure one year after midurethral sling surgery. Obstet Gynecol. 2011 Apr;117(4):913-921. doi: 10.1097/AOG.0b013e31820f3892.

• Responsible Party: HealthCore-NERI
• ClinicalTrials.gov Identifier: NCT00325039
• Other Study ID Numbers: DK58229
• First Posted: May 11, 2006
• Last Update Posted: Jan 14, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by HealthCore-NERI: Urinary Incontinence, Stress; Surgery
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis

Study Results

Participant Flow

Recruitment Details	Recruitment took place between April 2006 and June 2008. Patients were recruited from nine clinical sites. TOMUS (Trial Of Mid-Urethral Slings) was conducted by the Urinary Incontinence Treatment Network (UITN), a cooperative network consisting of urologists and urogynecologists at 9 clinical centers and a biostatistical coordinating center.
Pre-assignment Detail	3521 women were screened for eligibility. 1513 did not meet inclusion criteria; 1259 were eligible for inclusion in the study but were excluded (1001 declined to participate, 258 excluded for administrative reasons). 749 women provided written consent; of these 152 were excluded (63 ineligible, 66 withdrew consent, 23 administrative reasons).

Arm/Group Title	Retropubic (RMUS)	Transobturator (TMUS)
Arm/Group Description	retropubic mid-urethral sling (TVT)	transobturator mid-urethral sling (TVT-O and the Monarc)
Period Title: Overall Study
STARTED	298	299
COMPLETED	280	285
NOT COMPLETED	18	14

Baseline Characteristics

Arm/Group Title	Retropubic (RMUS)	Transobturator (TMUS)	Total
Arm/Group Description	retropubic mid-urethral sling (TVT)	transobturator mid-urethral sling (TVT-O and the Monarc)	Total of all reporting groups
Overall Participants	298	299	597
Age (Yrs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Yrs]	52.7 (10.5)	53.1 (11.5)	52.9 (11.0)
Sex: Female, Male (Count of Participants)
Female	298 100%	299 100%	597 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	298 100%	299 100%	597 100%

Outcome Measures

1. Primary Outcome

Title	Objective Treatment Success at 12 Months
Description	Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is <15g/24 hrs.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 and n=292 in RMUS, TMUS, respectively).

Arm/Group Title	Retropubic (RMUS)	Transobturator (TMUS)
Arm/Group Description	retropubic mid-urethral sling (TVT)	transobturator mid-urethral sling (TVT-O and the Monarc)
Measure Participants	291	292
Number [percentage of participants]	80.8 27.1%	77.7 26%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Retropubic (RMUS), Transobturator (TMUS)
	Comments	With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	difference in success rate (RMUS-TMUS)
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; -3.6 to 9.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Patient Satisfaction at 12 Months
Description	Patient satisfaction was assessed at the 12 month visit with the questions, "how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage?" Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as "satisfied" and neutral, most dissatisfied and completely dissatisfied as "not satisfied".
Time Frame	Follow-Up

Outcome Measure Data

Analysis Population Description

This is the number of women who answered the satisfaction questions at the 12 month visit (n=280 attended the 12 month visit in the retropubic arm and n=285 in the transobturator arm)

Arm/Group Title	Retropubic (RMUS)	Transobturator (TMUS)
Arm/Group Description	retropubic mid-urethral sling (TVT)	transobturator mid-urethral sling (TVT-O and the Monarc)
Measure Participants	262	261
Number [percentage of participants analyzed]	85.9 28.8%	90.0 30.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Retropubic (RMUS), Transobturator (TMUS)
	Comments	Although the primary aim of the study was designed as an equivalence trial, the secondary aims were considered as superiority tests.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments	This was not adjusted for multiple comparisons; the a priori threshold for statistical significance was 0.05.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in proportions
	Estimated Value	-4.1
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Subjective Treatment Success at 12 Months
Description	Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 in the Retropubic arm and n=292 in the transobturator arm).

Arm/Group Title	Retropubic (RMUS)	Transobturator (TMUS)
Arm/Group Description	retropubic mid-urethral sling (TVT)	transobturator mid-urethral sling (TVT-O and the Monarc)
Measure Participants	291	292
Number [percentage of participants]	62.2 20.9%	55.8 18.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Retropubic (RMUS), Transobturator (TMUS)
	Comments	With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	difference in success (RMUS - TMUS)
	Estimated Value	6.4
	Confidence Interval	(2-Sided) 95%; -1.6 to 14.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change in Quality of Life From Baseline to 12 Months
Description	Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).
Time Frame	Baseline - 12 months

Outcome Measure Data

Analysis Population Description

These are the number of patients with available quality of life data at the 12 month visit.

Arm/Group Title	Retropubic (RMUS)	Transobturator (TMUS)
Arm/Group Description	retropubic mid-urethral sling (TVT)	transobturator mid-urethral sling (TVT-O and the Monarc)
Measure Participants	264	263
Mean (Standard Deviation) [units on a scale]	126.8 (94.5)	132.9 (97.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Retropubic (RMUS), Transobturator (TMUS)
	Comments	The null hypothesis is that the two arms do not differ according to quality of life, as measured by the IIQ.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months
Description	Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

This is the number of participants who had complete UDI information at the 12 month visit.

Arm/Group Title	Retropubic (RMUS)	Transobturator (TMUS)
Arm/Group Description	retropubic mid-urethral sling (TVT)	transobturator mid-urethral sling (TVT-O and the Monarc)
Measure Participants	264	263
Mean (Standard Deviation) [units on a scale]	106.7 (48.0)	110.3 (51.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Retropubic (RMUS), Transobturator (TMUS)
	Comments	The UDI measure was compared using a two-sample t test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Arm/Group Title	Retropubic (RMUS)		Transobturator (TMUS)
Arm/Group Description	retropubic mid-urethral sling (TVT)		transobturator mid-urethral sling (TVT-O and the Monarc)
All Cause Mortality
	Retropubic (RMUS)		Transobturator (TMUS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Retropubic (RMUS)		Transobturator (TMUS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/298 (13.8%)		19/299 (6.4%)
Blood and lymphatic system disorders
Postoperative bleeding	1/298 (0.3%)	1	0/299 (0%)	0
Nervous system disorders
Neurologic symptoms	1/298 (0.3%)	1	0/299 (0%)	0
Renal and urinary disorders
Urethral perforation	1/298 (0.3%)	1	0/299 (0%)	0
Recurrent cystitis, leading to diagnostic cystoscopy	1/298 (0.3%)	1	0/299 (0%)	0
Voiding dysfunction requiring surgery, use of catheter or both	8/298 (2.7%)	9	0/299 (0%)	0
Surgical and medical procedures
Mesh exposure	9/298 (3%)	10	5/299 (1.7%)	5
Mesh erosion	1/298 (0.3%)	1	1/299 (0.3%)	1
Surgical site infection	0/298 (0%)	0	2/299 (0.7%)	2
Granulation tissue	0/298 (0%)	0	1/299 (0.3%)	1
Bladder perforation	15/298 (5%)	15	0/299 (0%)	0
Vaginal epithelial perforation	6/298 (2%)	6	13/299 (4.3%)	13
Urothelial abrasion	0/298 (0%)	0	1/299 (0.3%)	1
Vascular disorders
Pulmonary embolus	0/298 (0%)	0	1/299 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Retropubic (RMUS)		Transobturator (TMUS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	110/298 (36.9%)		89/299 (29.8%)
General disorders
Self-reported pain 6 or more weeks after procedure	7/298 (2.3%)	7	6/299 (2%)	7
Thrush	1/298 (0.3%)	1	0/299 (0%)	0
Medication reaction	0/298 (0%)	0	1/299 (0.3%)	1
Skin irritation	0/298 (0%)	0	1/299 (0.3%)	1
Bilateral leg pain	0/298 (0%)	0	1/299 (0.3%)	1
Decreased bladder sensation	1/298 (0.3%)	1	0/299 (0%)	0
Nervous system disorders
Neurologic symptom of numbness	6/298 (2%)	8	7/299 (2.3%)	9
Neurologic symptom of weakness	7/298 (2.3%)	7	21/299 (7%)	22
Psychiatric disorders
Anxiety	1/298 (0.3%)	1	0/299 (0%)	0
Renal and urinary disorders
Genitourinary	40/298 (13.4%)	46	24/299 (8%)	27
Voiding dysfunction	10/298 (3.4%)	16	4/299 (1.3%)	5
New urge incontinence	0/298 (0%)	0	1/299 (0.3%)	1
Persistent urge incontinence	36/298 (12.1%)	54	30/299 (10%)	55
Sac in pelvis (seroma)	0/298 (0%)	0	1/299 (0.3%)	1
Surgical and medical procedures
Mesh exposure	4/298 (1.3%)	4	3/299 (1%)	3
Surgical site infection	2/298 (0.7%)	2	2/299 (0.7%)	2
Granulation tissue	2/298 (0.7%)	2	2/299 (0.7%)	2
Wound edge separation	1/298 (0.3%)	1	0/299 (0%)	0
Minor wound	1/298 (0.3%)	1	0/299 (0%)	0
Vascular disorders
Vascular or hematologic	18/298 (6%)	20	7/299 (2.3%)	7

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.