OPUS: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

• Sponsor: NICHD Pelvic Floor Disorders Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT00460434
• Collaborator: Office of Research on Women's Health (ORWH) (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 337
• Locations: 8
• Arms: 2
• Duration (Months): 46
• Patients Per Site: 42.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Device: TVT; Other: Sham	Phase 2

Detailed Description

The overall objective of this randomized clinical trial is to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding TVT® at the time of the prolapse surgery among women with anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence.

The primary aims are:

In stress continent women planning vaginal surgery for pelvic organ prolapse:

1. To determine if the failure rate defined by subsequent treatment for urinary incontinence, signs or symptoms of bothersome urinary incontinence [defined as having at least moderate bother for any of 4 Pelvic Floor Distress Inventory (PFDI) incontinence items] differs between vaginal prolapse repair and vaginal prolapse repair plus TVT® during the first 3 months after the index surgery.

2. To determine if the prevalence of bothersome urinary incontinence at 12 months after the index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus TVT®, whether or not there was subsequent treatment for symptoms of urinary incontinence; i.e., to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding a TVT® at the time of the prolapse surgery.

3. To measure the total cost of care and relate the difference in cost of care between the two groups to differences in health utilities and health-related quality of life, which will allow us to examine the cost-effectiveness of prophylactic use of a TVT® at the time of prolapse surgery versus symptom-specific treatment of stress incontinence after prolapse surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 337 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Tension-free Vaginal Tape (TVT) surgery	Device: TVT; Prophylactic TVT
Sham Comparator: 2 Sham Tension-free Vaginal Tape (TVT) surgery	Other: Sham; Sham TVT

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence [3 months post-surgery]

   Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.

2. Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery [12 months post-surgery]

   Defined as a positive cough stress test or report of bothersome incontinence symptoms.

Secondary Outcome Measures

1. Medical Outcomes Study 36-Item Short Form Health Survey [Baseline, 3 months, and 12 Months post-surgery]

   This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up.

2. Positive Cough Stress Test [3 and 12 Months Post-surgery]

   A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml.

3. Symptoms of Incontinence [3 and 12 Months Post-surgery]

   Symptoms that were at least moderately bothersome to the participant (as measured by a response of "moderately" or "quite a bit" to any of the four items on the Pelvic Floor Distress Inventory regarding leakage).

4. Treatment for Incontinence [3 months post-surgery]

   The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence.

5. Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) [Baseline, 3 months, and 12 months post-surgery]

   PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up.

6. Urinary Distress Inventory (UDI) Obstructive Symptom Subscale [Baseline, 3 months, and 12 months post-surgery]

   Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.

7. Urinary Distress Inventory (UDI) Irritative Symptom Subscale [Baseline, 3 months, and 12 months post-surgery]

   Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.

8. Urinary Distress Inventory (UDI) Stress Subscale [Baseline, 3 months, and 12 months post-surgery]

   Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.

9. Incontinence Severity Index [Baseline, 3 months, and 12 months post-surgery]

   Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:

• Do you usually have a sensation of bulging or protrusion from the vaginal area?

• Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Anterior vaginal prolapse defined by pelvic organ prolapse quantification (POP-Q) Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm).

Surgical plan that includes a vaginal approach for apical or anterior prolapse repair.

Able and willing to complete data collection per protocol, including written informed consent.

Exclusion Criteria:

Pregnancy or planning pregnancy in the first postoperative year. Any prior mid urethral sling. Currently participating in another interventional study for urinary incontinence.

Untreated urinary tract infection (may be included after resolution).

Overt symptoms of stress urinary incontinence as defined by a positive response to any of the following 3 PFDI items:

• Do you usually experience urine leakage related to coughing, sneezing, or laughing?

• Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?

• Do you usually experience urine leakage related to lifting or bending over? Currently being treated for stress urinary incontinence with pessary/incontinence ring, pelvic floor muscle exercise or medication (duloxetine and imipramine, and alpha agonists).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35233-7333
2	USCD Medical Center	La Jolla	California	United States	92037
3	Kaiser Permanente	San Diego	California	United States	92120
4	Loyola University Medical Center	Maywood	Illinois	United States	60153
5	Duke University	Durham	North Carolina	United States	27710
6	Cleveland Clinic	Cleveland	Ohio	United States	44195
7	UT Southwestern	Dallas	Texas	United States	35249
8	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• NICHD Pelvic Floor Disorders Network
• Office of Research on Women's Health (ORWH)
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: John T Wei, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.

• Responsible Party: NICHD Pelvic Floor Disorders Network
• ClinicalTrials.gov Identifier: NCT00460434
• Other Study ID Numbers: 15P01; 2U01HD041249; 2U10HD041250; 2U10HD041261; 2U10HD041267; 1U10HD054136; 1U10HD054214; 1U10HD054215; 1U10HD054241
• First Posted: Apr 16, 2007
• Last Update Posted: May 30, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by NICHD Pelvic Floor Disorders Network: Prolapse; Urinary incontinence; TVT
• Additional relevant MeSH terms: Uterine Prolapse; Prolapse; Pelvic Organ Prolapse

Study Results

Participant Flow

Recruitment Details	All women presenting to the participating PFDN clinical centers with the complaint of prolapse, as defined by the inclusion criteria, will be screened for the subjective complaint of SUI using items on the PFDI. Eligible individuals will be offered RCT participation.
Pre-assignment Detail	Participants consisted of women who were being considered for an apical and/or anterior vaginal prolapse repair via a vaginal approach without subjective complaints of SUI. They must have had vaginal bulge symptoms (defined as positive responses to the PFDI), and anterior vaginal prolapse with point Aa at -1cm or greater (determined by POP-Q).

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Period Title: Overall Study
STARTED	165	172
3 Months	163	171
12 Months	162	165
COMPLETED	162	165
NOT COMPLETED	3	7

Baseline Characteristics

Arm/Group Title	Midurethral Sling	Sham Incision	Total
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.	Total of all reporting groups
Overall Participants	165	172	337
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.4 (10.8)	62.2 (10.2)	62.8 (10.5)
Sex: Female, Male (Count of Participants)
Female	165 100%	172 100%	337 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	143 86.7%	143 83.1%	286 84.9%
Black	10 6.1%	14 8.1%	24 7.1%
Asian	3 1.8%	2 1.2%	5 1.5%
Other	9 5.5%	13 7.6%	22 6.5%
Hispanic	21 12.7%	27 15.7%	48 14.2%
Not Hispanic	144 87.3%	145 84.3%	289 85.8%
Annual Income <$30,000 (Count of Participants)
Count of Participants [Participants]	31 18.8%	27 15.7%	58 17.2%
Married (Count of Participants)
Count of Participants [Participants]	121 73.3%	101 58.7%	222 65.9%
Body Mass Index (Kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m^2]	27.8 (4.9)	28.1 (5.5)	28.0 (5.2)
Pelvic Organ Prolapse Quantification (Count of Participants)
2	45 27.3%	48 27.9%	93 27.6%
3	107 64.8%	106 61.6%	213 63.2%
4	13 7.9%	18 10.5%	31 9.2%
Positive Cough Stress Test (Count of Participants)
Count of Participants [Participants]	54 32.7%	57 33.1%	111 32.9%
Anterior Vaginal - Prolapse Repair (Count of Participants)
Anterior Repair Only	20 12.1%	17 9.9%	37 11%
Apical Suspension Only	32 19.4%	42 24.4%	74 22%
Both Anterior Repair and Apical Suspension	101 61.2%	100 58.1%	201 59.6%
Colpocleisis	11 6.7%	13 7.6%	24 7.1%
Posterior Vaginal - Prolapse Repair (Count of Participants)
Count of Participants [Participants]	74 44.8%	80 46.5%	154 45.7%
Previous Hysterectomy (Count of Participants)
Count of Participants [Participants]	62 37.6%	66 38.4%	128 38%
Concomitant Hysterectomy (Count of Participants)
Count of Participants [Participants]	82 49.7%	83 48.3%	165 49%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence
Description	Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	165	172
Count of Participants [Participants]	39 23.6%	85 49.4%

2. Primary Outcome

Title	Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery
Description	Defined as a positive cough stress test or report of bothersome incontinence symptoms.
Time Frame	12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	165	172
Count of Participants [Participants]	45 27.3%	74 43%

3. Secondary Outcome

Title	Medical Outcomes Study 36-Item Short Form Health Survey
Description	This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up.
Time Frame	Baseline, 3 months, and 12 Months post-surgery

Outcome Measure Data

Analysis Population Description

Women who completed the Medical Outcomes Study 36-Item Short Form Health Survey at baseline and 3 and 12 months after the index surgery.

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	156	154
3 Months - Mental Component	1.5 (9.25)	0.6 (8.44)
3 Months - Physical Component	2.1 (8.21)	1.5 (7.52)
12 Months - Mental Component	1.9 (8.4)	2.0 (8.94)
12 Months - Physical Component	3.1 (9.23)	2.3 (7.51)

4. Secondary Outcome

Title	Positive Cough Stress Test
Description	A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml.
Time Frame	3 and 12 Months Post-surgery

Outcome Measure Data

Analysis Population Description

Women who came in for 3 and 12 month post-op office visits and completed a cough stress test.

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	158	157
3 Months	10 6.1%	54 31.4%
12 Months	5 3%	31 18%

5. Secondary Outcome

Title	Symptoms of Incontinence
Description	Symptoms that were at least moderately bothersome to the participant (as measured by a response of "moderately" or "quite a bit" to any of the four items on the Pelvic Floor Distress Inventory regarding leakage).
Time Frame	3 and 12 Months Post-surgery

Outcome Measure Data

Analysis Population Description

Women who completed questions in the Pelvic Floor Distress Inventory regarding leakage 3 and 12 months after their index surgery.

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	160	165
3 Months	15 9.1%	41 23.8%
12 Months	18 10.9%	30 17.4%

6. Secondary Outcome

Title	Treatment for Incontinence
Description	The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence.
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

Women who reported whether or not they needed treatment for any urinary incontinence.

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	164	172
Count of Participants [Participants]	11 6.7%	13 7.6%

7. Secondary Outcome

Title	Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)
Description	PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up.
Time Frame	Baseline, 3 months, and 12 months post-surgery

Outcome Measure Data

Analysis Population Description

Women who completed the PFDI UDI survey at baseline and 3 and 12 months after the index surgery.

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	160	155
3 Months	-44.9 (48.24)	-34.4 (44.92)
12 Months	-43.1 (44.25)	-39.3 (40.93)

8. Secondary Outcome

Title	Urinary Distress Inventory (UDI) Obstructive Symptom Subscale
Description	Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.
Time Frame	Baseline, 3 months, and 12 months post-surgery

Outcome Measure Data

Analysis Population Description

Women who completed the UDI obstructive symptom subscale survey at baseline and 3 and 12 months after the index surgery.

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	160	158
3 Months	-27.3 (22.69)	-28.0 (20.81)
12 Months	-26.4 (22.69)	-27.1 (21.39)

9. Secondary Outcome

Title	Urinary Distress Inventory (UDI) Irritative Symptom Subscale
Description	Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.
Time Frame	Baseline, 3 months, and 12 months post-surgery

Outcome Measure Data

Analysis Population Description

Women who completed the UDI irritative symptom subscale survey at baseline and 3 months after the index surgery.

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	160	158
3 Months	-12.5 (18.83)	-10.5 (17.06)
12 Months	-10.9 (17.15)	-11.6 (15.87)

10. Secondary Outcome

Title	Urinary Distress Inventory (UDI) Stress Subscale
Description	Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.
Time Frame	Baseline, 3 months, and 12 months post-surgery

Outcome Measure Data

Analysis Population Description

Women who completed the UDI stress subscale survey at baseline and 3 and 12 months after the index surgery.

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	160	155
3 Months	-5.1 (16.29)	4.2 (20.42)
12 Months	-5.7 (14.62)	-0.5 (16.89)

11. Secondary Outcome

Title	Incontinence Severity Index
Description	Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline.
Time Frame	Baseline, 3 months, and 12 months post-surgery

Outcome Measure Data

Analysis Population Description

Women who completed the Incontinence Severity Index survey at baseline and 3 and 12 months after the index surgery.

Arm/Group Title	Midurethral Sling	Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.	Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
Measure Participants	157	156
3 Months	-0.9 (3.01)	0.6 (3.26)
12 Months	-0.9 (2.7)	0.1 (2.7)

Adverse Events

Time Frame	12 months after index surgery
Arm/Group Title	Midurethral Sling		Sham Incision
Arm/Group Description	Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.		Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
All Cause Mortality
	Midurethral Sling		Sham Incision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Midurethral Sling		Sham Incision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/165 (17%)		20/172 (11.6%)
Cardiac disorders
Arrhythmia	1/165 (0.6%)		0/172 (0%)
Congestive heart failure	1/165 (0.6%)		0/172 (0%)
Endocrine disorders
Goitre	0/165 (0%)		1/172 (0.6%)
Gastrointestinal disorders
Diarrhea	1/165 (0.6%)		0/172 (0%)
Colitis ischaemic	1/165 (0.6%)		0/172 (0%)
Nausea	1/165 (0.6%)		1/172 (0.6%)
Vomiting	1/165 (0.6%)		1/172 (0.6%)
Small intestinal obstruction	1/165 (0.6%)		1/172 (0.6%)
Rectal prolapse	0/165 (0%)		1/172 (0.6%)
General disorders
Chest Pain	0/165 (0%)		1/172 (0.6%)
Infections and infestations
Urinary Tract Infection	2/165 (1.2%)		0/172 (0%)
Appendicitis	2/165 (1.2%)		0/172 (0%)
Diverticulitis	1/165 (0.6%)		0/172 (0%)
Abscess	0/165 (0%)		2/172 (1.2%)
Vaginal abscess	0/165 (0%)		1/172 (0.6%)
Injury, poisoning and procedural complications
Hypoxia	0/165 (0%)		1/172 (0.6%)
Hypotension	0/165 (0%)		1/172 (0.6%)
Haematoma	1/165 (0.6%)		0/172 (0%)
Post procedural haemorrhage	1/165 (0.6%)		0/172 (0%)
Anaemia postoperative	1/165 (0.6%)		0/172 (0%)
Lower limb fracture	1/165 (0.6%)		0/172 (0%)
Pain postoperative	1/165 (0.6%)		0/172 (0%)
Vaginal haemorrhage postoperative	1/165 (0.6%)		2/172 (1.2%)
Investigations
Pulse decreased	1/165 (0.6%)		0/172 (0%)
Abnormal electrocardiogram	1/165 (0.6%)		0/172 (0%)
Mammogram abnormal	0/165 (0%)		1/172 (0.6%)
Metabolism and nutrition disorders
Fluid Overload	1/165 (0.6%)		0/172 (0%)
Dehydration	1/165 (0.6%)		0/172 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/165 (0%)		2/172 (1.2%)
Lumbar spinal stenosis	0/165 (0%)		1/172 (0.6%)
Intervertebral disc protrusion	1/165 (0.6%)		0/172 (0%)
Pain in extremity	1/165 (0.6%)		0/172 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	0/165 (0%)		2/172 (1.2%)
Nervous system disorders
Dizziness	0/165 (0%)		1/172 (0.6%)
Transient ischaemic attack	0/165 (0%)		1/172 (0.6%)
Renal and urinary disorders
Nephrolithiasis	1/165 (0.6%)		0/172 (0%)
Pyelonephritis	0/165 (0%)		1/172 (0.6%)
Pollakiuria	0/165 (0%)		1/172 (0.6%)
Reproductive system and breast disorders
Pelvic pain	0/165 (0%)		1/172 (0.6%)
Respiratory, thoracic and mediastinal disorders
Shortness of breath	1/165 (0.6%)		0/172 (0%)
Pneumothorax	1/165 (0.6%)		0/172 (0%)
Surgical and medical procedures
Prolapse repair	6/165 (3.6%)		1/172 (0.6%)
Rectocele repair	1/165 (0.6%)		0/172 (0%)
Hip arthroplasty	1/165 (0.6%)		0/172 (0%)
Knee arthroplasty	1/165 (0.6%)		1/172 (0.6%)
Other (Not Including Serious) Adverse Events
	Midurethral Sling		Sham Incision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	92/165 (55.8%)		63/172 (36.6%)
Infections and infestations
Urinary tract infection	49/158 (31%)		30/164 (18.3%)
Injury, poisoning and procedural complications
Bladder perforation	11/164 (6.7%)		0/172 (0%)
Renal and urinary disorders
Bladder retention at hospital discharge	69/162 (42.6%)		51/170 (30%)
Bladder retention at 2 weeks	9/163 (5.5%)		1/169 (0.6%)

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.