Urogynecology Landmark Articles Flashcards
CARE Trial Full Name
Abdominal Sacrocolpopexy with Burch Colposuspension to Reduce Urinary Stress Incontinence
CARE Trial Alternative Name
Colpopexy and Urinary Reduction Efforts (CARE)
Abdominal Sacrocolpopexy with Burch Colposuspension to Reduce Urinary Stress Incontinence - Acronym
Colpopexy and Urinary Reduction Efforts (CARE)
CARE Trial Methods
Patients who selected ASC without significant SUI complaints get prophylactic Burch. 19% had SUI on CST.
CARE Trial Primary Outcome
Three months composite SUI (obj/sub/treat): 24% failure (SUI) Burch group vs 44% failure control.
CARE Trial Secondary Outcome
No significant difference between the Burch group and the control group in the frequency of urge incontinence (32.7 percent vs. 38.4 percent).
Control group was more likely to report bothersome stress incontinence than those in the Burch group who had stress incontinence (24.5 percent vs. 6.1 percent). SUI at 1 year: 20.9% Burch, 39.7% Control
TOMUS Trial Full Name
Retropubic versus Transobturator Midurethral Slings for Stress Incontinence
TOMUS Trial Alternative Name
The Trial of Mid-Urethral Slings (TOMUS)
Retropubic versus Transobturator Midurethral Slings for Stress Incontinence - Acronym
The Trial of Mid-Urethral Slings (TOMUS)
TOMUS Trial Primary Outcome - Methods
Treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment).
TOMUS Trial Primary Outcome - Results
Objective success 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (equivalence met).
Subjective success 62.2% and 55.8% (similar but not equivalent- wide margin).
TOMUS Trial Secondary Outcomes
The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% TOT (P=0.01).
There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life.
PROSPECT Trial Full Name
Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomized, controlled trials
PROSPECT Trial Alternative Name
PROlapse Surgery: Pragmatic Evaluation and randomized Controlled Trials
Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials - Acronym
PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials (PROSPECT)
PROSPECT Trial Primary Outcome- Methods
Comparing standard (native tissue) repair alone with standard repair augmented with either synthetic mesh (the mesh trial) or biological graft (the graft trial).
1 and 2 Year: participant-reported prolapse symptoms (i.e. the Pelvic Organ Prolapse Symptom Score [POP-SS]) and condition-specific (ie, prolapse-related) quality-of-life scores, analysed in the modified intention-to-treat population.
PROSPECT Trial Primary Outcome - Results
Mean POP-SS and prolapse-related quality of life scores at 1 and 2 years did not differ substantially between comparisons (Standard vs mesh, and standard vs graft).
PROSPECT Trial Secondary Outcome
Serious adverse events such as infection, urinary retention, or dyspareunia or other pain, excluding mesh complications, occurred with similar frequency in the groups over 1 year.
12% of mesh had mesh complications
OPTIMAL Trial Full Name
Factorial comparison of two transvaginal surgical approaches and of perioperative behavioral therapy for women with apical vaginal prolapse
OPTIMAL Trial Alternative Name
Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL)
Factorial comparison of two transvaginal surgical approaches and of perioperative behavioral therapy for women with apical vaginal prolapse - Acronym
Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL)
OPTIMAL Trial Primary Outcome - Methods
Transvaginal surgery (everyone had mid-urethral sling included) with randomization to SSLF or USLS; Behavioral intervention: Randomization to perioperative BPMT or usual care.
Surgical success: 1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success); 2) no bothersome vaginal bulge symptoms and 3) no retreatment for prolapse at 2 years.
Behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress inventory), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory) and anatomic success.
OPTIMAL Trial 5-Year Outcome
No significant difference between USLS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores at 5 years.
Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved.
OPTIMAL Trial Primary Outcome - Results
2 year Surgical Success: USLS = SSLF, 59% vs 61%
2 year Behavioral success: BPMT Does NOT help UDI or POPDI, or anatomic success.
Secondary: Serious adverse events similar USLS = SSLF
SISTER Trial Full Name
Burch Colposuspension versus Fascial Sling to Reduce Urinary Stress Incontinence
SISTER Trial Alternative Name
The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr)
Burch Colposuspension versus Fascial Sling to Reduce Urinary Stress Incontinence - Acronym
The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr)
SISTER Trial Primary Outcome - Methods
Pubovaginal sling vs Burch randomized among women with SUI and hypermobility.
Success in terms of overall urinary-incontinence measures, negative pad test, no urinary incontinence in a 3-day diary, negative cough and Valsalva stress test, no self-reported symptoms, and no retreatment.
SUI specific success - negative cough, no self-reported, no retreatment.
SISTER Trial Primary Outcome - Results
2 Year Pubovaginal Sling higher success than Burch.
Overall success: 47% vs 38%
SUI Success: 66% vs 49%
SISTER Trial Secondary Outcome
Pubovaginal sling worse mild adverse events than Burch (Urinary tract infections, difficulty voiding, and postoperative urge incontinence, revision).
VALUE Trial Full Name
A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery
VALUE Trial Alternative Name
Value of Urodynamic Evaluation (ValUE)
A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery - Acronym
Value of Urodynamic Evaluation (ValUE) Trial
VALUE Trial Primary Outcome - Methods
12 Month success: Reduction in UDI of 70%, “much better” or “very much better” on PGII Global Impression of Improvement
VALUE Trial Primary Outcome - Results
UDT no difference, office eval is non-inferior: 76.9% success in the urodynamic-testing group versus 77.2% in the evaluation-only group
VALUE Trial Secondary Outcome
No difference: incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events.
UDT patients - less likely to be diagnosed with OAB, more likely to be diagnosed with voiding dysfunction.
OPUS Trial Full Name
A midurethral sling to reduce incontinence after vaginal prolapse repair
OPUS Trial Alternative Name
Outcomes Following Vaginal Prolapse Repair and Midurethral Sling (OPUS)
A midurethral sling to reduce incontinence after vaginal prolapse repair - Acronym
Outcomes Following Vaginal Prolapse Repair and Midurethral Sling (OPUS)
OPUS Trial Primary Outcome - Methods
Stage 2+ POP , randomized sling or no sling (sham incisions)
Primary: Incontinence at 12 months, allowing for subsequent treatment for incontinence.
OPUS Trial Primary Outcome - Results
3 Month: Incontinence Sling 24% vs Sham 49%
Primary 12 Months, can retreat: Incontinence in Sling 27% vs Sham 43%.
NNT = 6.3
OPUS Trial Secondary Outcome
Sling bladder perf 6.7%, UTI 31%, bleeding 3.1%, incomplete bladder emptying 3.7 %.
Sham UTI 18%, 0% perf/bleed/incomplete empty
ESTEEM Trial Full Name
Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence
ESTEEM Trial Alternative Name
Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM)
ESTEEM Trial Primary Outcome - Methods
12-Month UDI Long Form Improvement
Sling vs. Sling + PT
Inclusion: Moderate+ SUI and UUI > 3 months
ESTEEM Trial Primary Outcome - Results
Both groups similar improvements in UDI -128 Combo, -114 Sling Only. UDI were both very much improved. Combo statistically barely better, but did not meet Minimally Important Difference
Similar serious advents (9% combo, 12% sling).
ABC Trial Full Name
Anticholinergic Therapy vs. OnabotulinumtoxinA for Urgency Urinary Incontinence
ABC Trial Alternative Name
Anticholinergic versus Botulinum toxin A Comparison trial for the treatment of bothersome urge urinary incontinence (ABC)
Anticholinergic Therapy vs. OnabotulinumtoxinA for Urgency Urinary Incontinence - Acronym
Anticholinergic versus Botulinum toxin A Comparison trial for the treatment of bothersome urge urinary incontinence (ABC)
ABC Trial Primary Outcome - Methods
UUI 5+ in 3 days, randomized to: Solifenacin 5->10 mg->Trospium 60 + Placebo Botox vs. Oral Placebo and real 100 U Botox.
Primary: Mean Reduction UUI episodes (over 6 months).
ABC Trial Primary + Secondary Outcome - Results
Primary: Botox 5->3.3 UUI, Meds 5->3.4 = similar.
Secondary: Botox Cure UUI: 27% vs Meds only 13%.
ABC Trial Secondary Outcomes - Side Effects
Dry mouth: 46% Meds vs 31% Botox
Catheter/Retention use at 2 months: 0% Meds vs 5% Botox
UTI: 13% Meds vs 33% Botox
ROSETTA Trial Full Name
OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women
ROSETTA Trial Alternative Name
Refractory Overactive Bladder: Sacral Neuromodulation vs Botulinum Toxin Assessment (ROSETTA)
OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women - Acronym
Refractory Overactive Bladder: Sacral Neuromodulation vs Botulinum Toxin Assessment (ROSETTA)
ROSETTA Trial Primary Outcome - Methods
200U Botox vs SNM
Primary: Change in mean daily UUI Episodes over 6 months.
ROSETTA Trial Primary Outcome - Results
Botox -3.9 UUI episodes vs SNM -3.3 (Botox slightly better statistically)
Remember 200 U Botox
ROSETTA Trial Secondary Outcome
Botox Greater OABQ improvement, better satisfaction (68% vs 60% SNM), better endorsement (78% vs 68%).
Same: Convenience, adverse events (88%/84%), treatment preference (92/89).
More UTI in Botox 35% vs 11% SNM. Self cath 8% Botox 2 months, 1% 6 months.
3% SNM Removed.
SUMIT Trial Full Name
Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome
SUMIT Trial Alternative Name
Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT)
SUMIT Trial Primary Outcome - Methods
At 13 (12 weeks therapy) weeks - Weekly PTNS vs Sham
OAB and QOL questionnaires, 3 day Voiding Diary.
SUMIT Trial Primary Outcome - Results
Global Response Overall Bladder sx: PTNS 55% moderate+ improvement, vs 21% Sham. Also all individual sx PTNS better than Sham.
Voiding Diary PTNS > Sham: Frequency, nocturia, voids with urgency, and UUI episodes.
No adverse events.
InSite Trial Full Name
Results of a Prospective, Randomized, Multicenter Study Evaluating Sacral Neuromodulation With InterStim Therapy Compared to Standard Medical Therapy at 6-Months in Subjects With Mild Symptoms of Overactive Bladder
InSite Trial Primary Outcome - Methods
2+ leaks in 3 days, 8+ Freq, Fail one med: randomized to SNM or SMT
Primary: 12 Months 50% improvement from baseline in average leaks/ day or voids/day or a return to normal voiding (<8 voids/day)
InSite Trial Primary Outcome - Results
12 month:
ITT: SNM greater success 66% vs SMT 42%.
As Treated: 76% success SNM vs SMT 49%.
InSite Trial Secondary Outcome
SNM greater QOL 86% improved vs 44% SMT
31% Device adverse events, 27% Medicine adverse events
OPTIMAL 5-Year Outcome
Compared with two years, surgical failure increased (40%->%65%), although prolapse symptom scores remained improved. Still no benefit of PT.
Atlas Trial Full Name
Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial
Atlas Trial Alternative Name
Ambulatory Treatments for Leakage Associated with Stress Incontinence
Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial - Acronym
ATLAS (Ambulatory Treatments for Leakage Associated with Stress Incontinence)
Atlas Trial Methods
Randomized Behavioral, Continence Pessary, or Both. PFDI and PGI-I. 3, 6 and 12 months. Combo therapy had to be superior to both comparisons (to recommend combo therapy).
Atlas Trial Primary Outcome
3 Month:
Pessary similar PGI-I as Behavior (40, 49% Better). No sx Behavior > Pessary (49% vs 33%). Satisfaction Behavior > Pessary.
Combo > than Pessary on PGI-I and PFDI. Combo not better than Behavior.
Atlas Trial Secondary Outcome
All Differences (Pessary, Behav, Combo) gone at 12 months (but all >50% satisfaction of people still on treatment).
