Trial Outcomes & Findings for Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial (NCT NCT00460434)
NCT ID: NCT00460434
Last Updated: 2018-05-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
337 participants
Primary outcome timeframe
3 months post-surgery
Results posted on
2018-05-30
Participant Flow
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.
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).
Participant milestones
| Measure |
Midurethral Sling
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
172
|
|
Overall Study
3 Months
|
163
|
171
|
|
Overall Study
12 Months
|
162
|
165
|
|
Overall Study
COMPLETED
|
162
|
165
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Midurethral Sling
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
Baseline Characteristics
Self-reported question, population is those who provided a response.
Baseline characteristics by cohort
| Measure |
Midurethral Sling
n=165 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=172 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
Total
n=337 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 10.8 • n=165 Participants
|
62.2 years
STANDARD_DEVIATION 10.2 • n=172 Participants
|
62.8 years
STANDARD_DEVIATION 10.5 • n=337 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=165 Participants
|
172 Participants
n=172 Participants
|
337 Participants
n=337 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=165 Participants
|
0 Participants
n=172 Participants
|
0 Participants
n=337 Participants
|
|
Race/Ethnicity, Customized
White
|
143 Participants
n=165 Participants
|
143 Participants
n=172 Participants
|
286 Participants
n=337 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=165 Participants
|
14 Participants
n=172 Participants
|
24 Participants
n=337 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=165 Participants
|
2 Participants
n=172 Participants
|
5 Participants
n=337 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=165 Participants
|
13 Participants
n=172 Participants
|
22 Participants
n=337 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
21 Participants
n=165 Participants
|
27 Participants
n=172 Participants
|
48 Participants
n=337 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic
|
144 Participants
n=165 Participants
|
145 Participants
n=172 Participants
|
289 Participants
n=337 Participants
|
|
Annual Income <$30,000
|
31 Participants
n=64 Participants • Self-reported question, population is those who provided a response.
|
27 Participants
n=65 Participants • Self-reported question, population is those who provided a response.
|
58 Participants
n=129 Participants • Self-reported question, population is those who provided a response.
|
|
Married
|
121 Participants
n=163 Participants • Self-reported question, population is those who provided a response.
|
101 Participants
n=161 Participants • Self-reported question, population is those who provided a response.
|
222 Participants
n=324 Participants • Self-reported question, population is those who provided a response.
|
|
Body Mass Index
|
27.8 Kg/m^2
STANDARD_DEVIATION 4.9 • n=165 Participants
|
28.1 Kg/m^2
STANDARD_DEVIATION 5.5 • n=172 Participants
|
28.0 Kg/m^2
STANDARD_DEVIATION 5.2 • n=337 Participants
|
|
Pelvic Organ Prolapse Quantification
2
|
45 Participants
n=165 Participants
|
48 Participants
n=172 Participants
|
93 Participants
n=337 Participants
|
|
Pelvic Organ Prolapse Quantification
3
|
107 Participants
n=165 Participants
|
106 Participants
n=172 Participants
|
213 Participants
n=337 Participants
|
|
Pelvic Organ Prolapse Quantification
4
|
13 Participants
n=165 Participants
|
18 Participants
n=172 Participants
|
31 Participants
n=337 Participants
|
|
Positive Cough Stress Test
|
54 Participants
n=165 Participants
|
57 Participants
n=172 Participants
|
111 Participants
n=337 Participants
|
|
Anterior Vaginal - Prolapse Repair
Anterior Repair Only
|
20 Participants
n=165 Participants
|
17 Participants
n=172 Participants
|
37 Participants
n=337 Participants
|
|
Anterior Vaginal - Prolapse Repair
Apical Suspension Only
|
32 Participants
n=165 Participants
|
42 Participants
n=172 Participants
|
74 Participants
n=337 Participants
|
|
Anterior Vaginal - Prolapse Repair
Both Anterior Repair and Apical Suspension
|
101 Participants
n=165 Participants
|
100 Participants
n=172 Participants
|
201 Participants
n=337 Participants
|
|
Anterior Vaginal - Prolapse Repair
Colpocleisis
|
11 Participants
n=165 Participants
|
13 Participants
n=172 Participants
|
24 Participants
n=337 Participants
|
|
Posterior Vaginal - Prolapse Repair
|
74 Participants
n=165 Participants
|
80 Participants
n=172 Participants
|
154 Participants
n=337 Participants
|
|
Previous Hysterectomy
|
62 Participants
n=165 Participants
|
66 Participants
n=172 Participants
|
128 Participants
n=337 Participants
|
|
Concomitant Hysterectomy
|
82 Participants
n=165 Participants
|
83 Participants
n=172 Participants
|
165 Participants
n=337 Participants
|
PRIMARY outcome
Timeframe: 3 months post-surgeryDefined 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.
Outcome measures
| Measure |
Midurethral Sling
n=165 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=172 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence
|
39 Participants
|
85 Participants
|
PRIMARY outcome
Timeframe: 12 months post-surgeryDefined as a positive cough stress test or report of bothersome incontinence symptoms.
Outcome measures
| Measure |
Midurethral Sling
n=165 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=172 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery
|
45 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 12 Months post-surgeryPopulation: Women who completed the Medical Outcomes Study 36-Item Short Form Health Survey at baseline and 3 and 12 months after the index 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.
Outcome measures
| Measure |
Midurethral Sling
n=156 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=154 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Medical Outcomes Study 36-Item Short Form Health Survey
3 Months - Mental Component
|
1.5 units on a scale
Standard Deviation 9.25
|
0.6 units on a scale
Standard Deviation 8.44
|
|
Medical Outcomes Study 36-Item Short Form Health Survey
3 Months - Physical Component
|
2.1 units on a scale
Standard Deviation 8.21
|
1.5 units on a scale
Standard Deviation 7.52
|
|
Medical Outcomes Study 36-Item Short Form Health Survey
12 Months - Mental Component
|
1.9 units on a scale
Standard Deviation 8.4
|
2.0 units on a scale
Standard Deviation 8.94
|
|
Medical Outcomes Study 36-Item Short Form Health Survey
12 Months - Physical Component
|
3.1 units on a scale
Standard Deviation 9.23
|
2.3 units on a scale
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: 3 and 12 Months Post-surgeryPopulation: Women who came in for 3 and 12 month post-op office visits and completed a cough stress test.
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.
Outcome measures
| Measure |
Midurethral Sling
n=158 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=157 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Positive Cough Stress Test
3 Months
|
10 Participants
|
54 Participants
|
|
Positive Cough Stress Test
12 Months
|
5 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 3 and 12 Months Post-surgeryPopulation: Women who completed questions in the Pelvic Floor Distress Inventory regarding leakage 3 and 12 months after their index 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).
Outcome measures
| Measure |
Midurethral Sling
n=160 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=165 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Symptoms of Incontinence
3 Months
|
15 Participants
|
41 Participants
|
|
Symptoms of Incontinence
12 Months
|
18 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 3 months post-surgeryPopulation: Women who reported whether or not they needed treatment for any urinary incontinence.
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.
Outcome measures
| Measure |
Midurethral Sling
n=164 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=172 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Treatment for Incontinence
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 12 months post-surgeryPopulation: Women who completed the PFDI UDI survey at baseline and 3 and 12 months after the index 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.
Outcome measures
| Measure |
Midurethral Sling
n=160 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=155 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)
3 Months
|
-44.9 units on a scale
Standard Deviation 48.24
|
-34.4 units on a scale
Standard Deviation 44.92
|
|
Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)
12 Months
|
-43.1 units on a scale
Standard Deviation 44.25
|
-39.3 units on a scale
Standard Deviation 40.93
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 12 months post-surgeryPopulation: Women who completed the UDI obstructive symptom subscale survey at baseline and 3 and 12 months after the index 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.
Outcome measures
| Measure |
Midurethral Sling
n=160 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=158 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Urinary Distress Inventory (UDI) Obstructive Symptom Subscale
3 Months
|
-27.3 units on a scale
Standard Deviation 22.69
|
-28.0 units on a scale
Standard Deviation 20.81
|
|
Urinary Distress Inventory (UDI) Obstructive Symptom Subscale
12 Months
|
-26.4 units on a scale
Standard Deviation 22.69
|
-27.1 units on a scale
Standard Deviation 21.39
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 12 months post-surgeryPopulation: Women who completed the UDI irritative symptom subscale survey at baseline and 3 months after the index 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.
Outcome measures
| Measure |
Midurethral Sling
n=160 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=158 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Urinary Distress Inventory (UDI) Irritative Symptom Subscale
3 Months
|
-12.5 units on a scale
Standard Deviation 18.83
|
-10.5 units on a scale
Standard Deviation 17.06
|
|
Urinary Distress Inventory (UDI) Irritative Symptom Subscale
12 Months
|
-10.9 units on a scale
Standard Deviation 17.15
|
-11.6 units on a scale
Standard Deviation 15.87
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 12 months post-surgeryPopulation: Women who completed the UDI stress subscale survey at baseline and 3 and 12 months after the index 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.
Outcome measures
| Measure |
Midurethral Sling
n=160 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=155 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Urinary Distress Inventory (UDI) Stress Subscale
3 Months
|
-5.1 units on a scale
Standard Deviation 16.29
|
4.2 units on a scale
Standard Deviation 20.42
|
|
Urinary Distress Inventory (UDI) Stress Subscale
12 Months
|
-5.7 units on a scale
Standard Deviation 14.62
|
-0.5 units on a scale
Standard Deviation 16.89
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 12 months post-surgeryPopulation: Women who completed the Incontinence Severity Index survey at baseline and 3 and 12 months after the index 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.
Outcome measures
| Measure |
Midurethral Sling
n=157 Participants
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=156 Participants
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Incontinence Severity Index
3 Months
|
-0.9 units on a scale
Standard Deviation 3.01
|
0.6 units on a scale
Standard Deviation 3.26
|
|
Incontinence Severity Index
12 Months
|
-0.9 units on a scale
Standard Deviation 2.7
|
0.1 units on a scale
Standard Deviation 2.7
|
Adverse Events
Midurethral Sling
Serious events: 28 serious events
Other events: 92 other events
Deaths: 0 deaths
Sham Incision
Serious events: 20 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Midurethral Sling
n=165 participants at risk
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=172 participants at risk
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Cardiac disorders
Congestive heart failure
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Investigations
Pulse decreased
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Investigations
Abnormal electrocardiogram
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Injury, poisoning and procedural complications
Hypoxia
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Injury, poisoning and procedural complications
Hypotension
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Nervous system disorders
Dizziness
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
General disorders
Chest Pain
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Infections and infestations
Urinary Tract Infection
|
1.2%
2/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Metabolism and nutrition disorders
Dehydration
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Gastrointestinal disorders
Diarrhea
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Surgical and medical procedures
Prolapse repair
|
3.6%
6/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Infections and infestations
Appendicitis
|
1.2%
2/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Gastrointestinal disorders
Nausea
|
0.61%
1/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Infections and infestations
Diverticulitis
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.61%
1/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Surgical and medical procedures
Rectocele repair
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Injury, poisoning and procedural complications
Haematoma
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Endocrine disorders
Goitre
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.61%
1/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/165 • 12 months after index surgery
|
1.2%
2/172 • 12 months after index surgery
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/165 • 12 months after index surgery
|
1.2%
2/172 • 12 months after index surgery
|
|
Investigations
Mammogram abnormal
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Injury, poisoning and procedural complications
Pain postoperative
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.61%
1/165 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Infections and infestations
Abscess
|
0.00%
0/165 • 12 months after index surgery
|
1.2%
2/172 • 12 months after index surgery
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
|
Injury, poisoning and procedural complications
Vaginal haemorrhage postoperative
|
0.61%
1/165 • 12 months after index surgery
|
1.2%
2/172 • 12 months after index surgery
|
|
Infections and infestations
Vaginal abscess
|
0.00%
0/165 • 12 months after index surgery
|
0.58%
1/172 • 12 months after index surgery
|
Other adverse events
| Measure |
Midurethral Sling
n=165 participants at risk
Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
|
Sham Incision
n=172 participants at risk
Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bladder perforation
|
6.7%
11/164 • 12 months after index surgery
|
0.00%
0/172 • 12 months after index surgery
|
|
Infections and infestations
Urinary tract infection
|
31.0%
49/158 • 12 months after index surgery
|
18.3%
30/164 • 12 months after index surgery
|
|
Renal and urinary disorders
Bladder retention at hospital discharge
|
42.6%
69/162 • 12 months after index surgery
|
30.0%
51/170 • 12 months after index surgery
|
|
Renal and urinary disorders
Bladder retention at 2 weeks
|
5.5%
9/163 • 12 months after index surgery
|
0.59%
1/169 • 12 months after index surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place