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Urogynecology Landmark Articles > Urogynecology Landmark Articles > Flashcards

Urogynecology Landmark Articles Flashcards

1
Q

CARE Trial Full Name

A

Abdominal Sacrocolpopexy with Burch Colposuspension to Reduce Urinary Stress Incontinence

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2
Q

CARE Trial Alternative Name

A

Colpopexy and Urinary Reduction Efforts (CARE)

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3
Q

Abdominal Sacrocolpopexy with Burch Colposuspension to Reduce Urinary Stress Incontinence - Acronym

A

Colpopexy and Urinary Reduction Efforts (CARE)

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4
Q

CARE Trial Methods

A

Patients who selected ASC without significant SUI complaints get prophylactic Burch. 19% had SUI on CST.

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5
Q

CARE Trial Primary Outcome

A

Three months composite SUI (obj/sub/treat): 24% failure (SUI) Burch group vs 44% failure control.

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6
Q

CARE Trial Secondary Outcome

A

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

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7
Q

TOMUS Trial Full Name

A

Retropubic versus Transobturator Midurethral Slings for Stress Incontinence

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8
Q

TOMUS Trial Alternative Name

A

The Trial of Mid-Urethral Slings (TOMUS)

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9
Q

Retropubic versus Transobturator Midurethral Slings for Stress Incontinence - Acronym

A

The Trial of Mid-Urethral Slings (TOMUS)

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10
Q

TOMUS Trial Primary Outcome - Methods

A

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).

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11
Q

TOMUS Trial Primary Outcome - Results

A

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).

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12
Q

TOMUS Trial Secondary Outcomes

A

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.

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13
Q

PROSPECT Trial Full Name

A

Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomized, controlled trials

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14
Q

PROSPECT Trial Alternative Name

A

PROlapse Surgery: Pragmatic Evaluation and randomized Controlled Trials

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15
Q

Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials - Acronym

A

PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials (PROSPECT)

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16
Q

PROSPECT Trial Primary Outcome- Methods

A

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.

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17
Q

PROSPECT Trial Primary Outcome - Results

A

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).

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18
Q

PROSPECT Trial Secondary Outcome

A

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

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19
Q

OPTIMAL Trial Full Name

A

Factorial comparison of two transvaginal surgical approaches and of perioperative behavioral therapy for women with apical vaginal prolapse

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20
Q

OPTIMAL Trial Alternative Name

A

Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL)

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21
Q

Factorial comparison of two transvaginal surgical approaches and of perioperative behavioral therapy for women with apical vaginal prolapse - Acronym

A

Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL)

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22
Q

OPTIMAL Trial Primary Outcome - Methods

A 
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.

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23
Q

OPTIMAL Trial 5-Year Outcome

A

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.

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24
Q

OPTIMAL Trial Primary Outcome - Results

A

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

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25
Q

SISTER Trial Full Name

A

Burch Colposuspension versus Fascial Sling to Reduce Urinary Stress Incontinence

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26
Q

SISTER Trial Alternative Name

A

The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr)

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27
Q

Burch Colposuspension versus Fascial Sling to Reduce Urinary Stress Incontinence - Acronym

A

The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr)

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28
Q

SISTER Trial Primary Outcome - Methods

A

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.

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29
Q

SISTER Trial Primary Outcome - Results

A

2 Year Pubovaginal Sling higher success than Burch.
Overall success: 47% vs 38%
SUI Success: 66% vs 49%

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30
Q

SISTER Trial Secondary Outcome

A

Pubovaginal sling worse mild adverse events than Burch (Urinary tract infections, difficulty voiding, and postoperative urge incontinence, revision).

31
Q

VALUE Trial Full Name

A

A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery

32
Q

VALUE Trial Alternative Name

A

Value of Urodynamic Evaluation (ValUE)

33
Q

A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery - Acronym

A

Value of Urodynamic Evaluation (ValUE) Trial

34
Q

VALUE Trial Primary Outcome - Methods

A

12 Month success: Reduction in UDI of 70%, “much better” or “very much better” on PGII Global Impression of Improvement

35
Q

VALUE Trial Primary Outcome - Results

A

UDT no difference, office eval is non-inferior: 76.9% success in the urodynamic-testing group versus 77.2% in the evaluation-only group

36
Q

VALUE Trial Secondary Outcome

A

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.

37
Q

OPUS Trial Full Name

A

A midurethral sling to reduce incontinence after vaginal prolapse repair

38
Q

OPUS Trial Alternative Name

A

Outcomes Following Vaginal Prolapse Repair and Midurethral Sling (OPUS)

39
Q

A midurethral sling to reduce incontinence after vaginal prolapse repair - Acronym

A

Outcomes Following Vaginal Prolapse Repair and Midurethral Sling (OPUS)

40
Q

OPUS Trial Primary Outcome - Methods

A

Stage 2+ POP , randomized sling or no sling (sham incisions)

Primary: Incontinence at 12 months, allowing for subsequent treatment for incontinence.

41
Q

OPUS Trial Primary Outcome - Results

A

3 Month: Incontinence Sling 24% vs Sham 49%

Primary 12 Months, can retreat: Incontinence in Sling 27% vs Sham 43%.

NNT = 6.3

42
Q

OPUS Trial Secondary Outcome

A

Sling bladder perf 6.7%, UTI 31%, bleeding 3.1%, incomplete bladder emptying 3.7 %.

Sham UTI 18%, 0% perf/bleed/incomplete empty

43
Q

ESTEEM Trial Full Name

A

Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence

44
Q

ESTEEM Trial Alternative Name

A

Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM)

45
Q

ESTEEM Trial Primary Outcome - Methods

A

12-Month UDI Long Form Improvement

Sling vs. Sling + PT

Inclusion: Moderate+ SUI and UUI > 3 months

46
Q

ESTEEM Trial Primary Outcome - Results

A

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).

47
Q

ABC Trial Full Name

A

Anticholinergic Therapy vs. OnabotulinumtoxinA for Urgency Urinary Incontinence

48
Q

ABC Trial Alternative Name

A

Anticholinergic versus Botulinum toxin A Comparison trial for the treatment of bothersome urge urinary incontinence (ABC)

49
Q

Anticholinergic Therapy vs. OnabotulinumtoxinA for Urgency Urinary Incontinence - Acronym

A

Anticholinergic versus Botulinum toxin A Comparison trial for the treatment of bothersome urge urinary incontinence (ABC)

50
Q

ABC Trial Primary Outcome - Methods

A

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).

51
Q

ABC Trial Primary + Secondary Outcome - Results

A

Primary: Botox 5->3.3 UUI, Meds 5->3.4 = similar.

Secondary: Botox Cure UUI: 27% vs Meds only 13%.

52
Q

ABC Trial Secondary Outcomes - Side Effects

A

Dry mouth: 46% Meds vs 31% Botox

Catheter/Retention use at 2 months: 0% Meds vs 5% Botox

UTI: 13% Meds vs 33% Botox

53
Q

ROSETTA Trial Full Name

A

OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women

54
Q

ROSETTA Trial Alternative Name

A

Refractory Overactive Bladder: Sacral Neuromodulation vs Botulinum Toxin Assessment (ROSETTA)

55
Q

OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women - Acronym

A

Refractory Overactive Bladder: Sacral Neuromodulation vs Botulinum Toxin Assessment (ROSETTA)

56
Q

ROSETTA Trial Primary Outcome - Methods

A

200U Botox vs SNM

Primary: Change in mean daily UUI Episodes over 6 months.

57
Q

ROSETTA Trial Primary Outcome - Results

A

Botox -3.9 UUI episodes vs SNM -3.3 (Botox slightly better statistically)

Remember 200 U Botox

58
Q

ROSETTA Trial Secondary Outcome

A

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.

59
Q

SUMIT Trial Full Name

A

Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome

60
Q

SUMIT Trial Alternative Name

A

Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT)

61
Q

SUMIT Trial Primary Outcome - Methods

A

At 13 (12 weeks therapy) weeks - Weekly PTNS vs Sham

OAB and QOL questionnaires, 3 day Voiding Diary.

62
Q

SUMIT Trial Primary Outcome - Results

A

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.

63
Q

InSite Trial Full Name

A

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

64
Q

InSite Trial Primary Outcome - Methods

A

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)

65
Q

InSite Trial Primary Outcome - Results

A

12 month:
ITT: SNM greater success 66% vs SMT 42%.

As Treated: 76% success SNM vs SMT 49%.

66
Q

InSite Trial Secondary Outcome

A

SNM greater QOL 86% improved vs 44% SMT

31% Device adverse events, 27% Medicine adverse events

67
Q

OPTIMAL 5-Year Outcome

A

Compared with two years, surgical failure increased (40%->%65%), although prolapse symptom scores remained improved. Still no benefit of PT.

68
Q

Atlas Trial Full Name

A

Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial

69
Q

Atlas Trial Alternative Name

A

Ambulatory Treatments for Leakage Associated with Stress Incontinence

70
Q

Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial - Acronym

A

ATLAS (Ambulatory Treatments for Leakage Associated with Stress Incontinence)

71
Q

Atlas Trial Methods

A

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).

72
Q

Atlas Trial Primary Outcome

A

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.

73
Q

Atlas Trial Secondary Outcome

A

All Differences (Pessary, Behav, Combo) gone at 12 months (but all >50% satisfaction of people still on treatment).

Urogynecology Landmark Articles (2 decks)

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