EUF-137; No. of Pages 7 EUROPEAN UROLOGY FOCUS XXX (2016) XXX–XXX
available at www.sciencedirect.com journal homepage: www.europeanurology.com/eufocus
Review – Female Urology – Incontinence
Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization Maude E. Carmel a,*, Donna Y. Deng b, Tamsin J. Greenwell c, Philippe E. Zimmern a a
University of Texas Southwestern, Dallas, TX, USA; b University of California San Francisco, San Francisco, CA, USA; c University College London Hospitals,
London, UK
Article info
Abstract
Article history: Accepted March 14, 2016
Context: There is currently no standardized definition of success for surgery for stress urinary incontinence (SUI) and voiding dysfunction (VD) in women. Objective: To review the use of outcome measures (OMs) and definitions of success in the literature on SUI and VD surgery in women in an attempt to provide recommendations for future publications. Evidence acquisition: A PubMed search of all English language full-text articles on SUI and VD surgery in women published between 2010 and 2015 was performed. A list of randomized trials and prospective and retrospective studies was obtained. Specific objective and subjective OMs used to define success were reviewed. Evidence synthesis: Some 95 articles met the inclusion criteria for SUI surgery outcomes. Most trials reported outcomes at 12 mo after surgery. The majority (n = 48) reported their primary outcomes using both objective and subjective success measures, 24 defined success using subjective OMs alone, and 23 using objective OMs alone. The OMs most frequently used for objective success were a negative cough stress test (CST), a negative pad test, and the absence of retreatment for SUI. The definition of subjective success most often involved questionnaires. The questionnaires most frequently used were Patient Global Impression of Improvement (PGI-I), Urinary Distress Inventory (UDI)/UDI-6, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and Medical Epidemiologic and Social Aspects of Aging (MESA). Only 11 studies on OMs used for VD surgery were published between 2010 and 2015. The two most common criteria used for success were measurement of postvoid residual urine (PVR) and subjective resolution of VD symptoms. Conclusions: There is great heterogeneity in the definition of success used after surgery for SUI or VD in women. For SUI surgery, we recommend use of the CST and a 1-h pad test for the definition of objective success, and of the UDI/UDI-6, Incontinence Impact Questionnaire (IIQ), King’s Health Questionnaire (KHQ), ICIQ-SF, or PGI-I questionnaire for subjective success. For VD surgery, cure should include measurement of PVR and selfreported resolution of VD symptoms. Patient summary: We looked at the definition of success used for surgery for stress urinary incontinence (SUI) and voiding dysfunction (VD) in women. We found that there is great heterogeneity among studies, making study comparison extremely difficult. According to the outcome measures used most frequently, we make recommendations regarding the definition of cure for SUI and VD in women to be used in future publications. # 2016 Published by Elsevier B.V. on behalf of European Association of Urology.
Associate Editor: James Catto Keywords: Outcome measures Stress urinary incontinence Voiding dysfunction
* Corresponding author. University of Texas Southwestern, 5323 Harry Hines Boulevard, Dallas, TX 75390-9110, USA. Tel. +1 214 6486333; Fax: +1 214 6488786. E-mail address: [email protected] (M.E. Carmel).
http://dx.doi.org/10.1016/j.euf.2016.03.005 2405-4569/# 2016 Published by Elsevier B.V. on behalf of European Association of Urology.
Please cite this article in press as: Carmel ME, et al. Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.03.005
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EUROPEAN UROLOGY FOCUS XXX (2016) XXX–XXX
1.
Introduction
There is currently no standardized definition of success for surgery for stress urinary incontinence (SUI) and voiding dysfunction (VD) in women. This makes it very challenging to compare different procedures owing to the wide heterogeneity among the outcome variables used. There have been a few recent attempts to develop both core and minimum outcome sets to be reported in every study to provide consistent evidence from which to draw meaningful conclusions. The last Cochrane review of minimally invasive midurethral sling operations for the treatment of SUI noted that the variable quality of evidence presented limited the ability to make strong recommendations [1]. The need for more robustly designed randomized controlled trials with standardized objective and validated subjective outcomes was highlighted. Reporting both subjective and objective outcomes is extremely important because of the well-known discrepancies between clinical and objective measures recorded by physicians and the subjective perception of symptoms by patients [2]. The International Continence Society (ICS) and the 4th International Consultation on Incontinence (ICI) previously published a list of recommended outcome measures (OMs) for incontinence therapy, including a list of subjective and objective outcomes [3]. Grade A, ‘‘highly recommended’’ questionnaires were those with well-published data proving their validity, reliability, and responsiveness to change. The use of highquality questionnaires was strongly recommended for assessing both a patient’s perspective of symptoms and their impact on quality of life. Unfortunately, most recent studies have not followed these guidelines and significant inconsistency in OM reporting remains. Definitions of cure and improvement or failure are also extremely variable, with most relying on unvalidated questionnaires and patient selfassessment. This makes useful comparisons between published studies very difficult, if not impossible. Multiple reports have demonstrated the need for a consensus and standardization in the choice of OMs used for reporting of anti-incontinence and VD procedures [1,4,5]. The aim of this study was to review the use of OMs and definition of success in the literature on SUI and VD surgery in an attempt to provide much-needed recommendations and to gain some consensus for future publications. 2.
Evidence acquisition
We conducted a literature search in September 2015 using the PubMed database. Filters were applied to capture only full-length articles published in English between January 2010 and September 2015. We limited our search to the past 5 yr in an effort to base our recommendations on the most recent data available. We included articles reporting on outcomes of surgery for SUI and for incomplete emptying, urinary retention, and VD. The surgeries of interest for the treatment of SUI were sling procedures (midurethral sling, mini-sling and pubovaginal slings), Burch and Marshall-Marchetti-Krantz urethropexy, and needle suspensions. The following search was
performed: ‘‘stress urinary incontinence’’ AND ‘‘surgery’’ AND ‘‘women’’. A filter term for clinical trials was also used. Surgeries for the treatment of VD and incomplete emptying were sling excision or revision or incision, urethrolysis, and bladder neck incision. The following searches were performed: ‘‘women’’ AND ‘‘primary bladder neck obstruction’’; ‘‘sling excision’’ AND ‘‘women’’; ‘‘sling incision’’ AND ‘‘women’’; ‘‘urinary retention’’ AND ‘‘surgery’’ AND ‘‘women’’; ‘‘voiding dysfunction’’ AND ‘‘surgery’’ AND ‘‘women’’. We excluded articles reporting outcomes for patients with pelvic organ prolapse (unless outcomes for SUI were well defined) or neurogenic bladder, and for incontinence in men, children and pregnant women. Outcomes of treatments for urgency urinary incontinence were excluded from this review as its management is mostly nonsurgical and the success criteria used for sacral nerve neuromodulation are already well established. Bulking agents were also excluded from this review to focus only on open and vaginal surgical treatments for SUI. Abstracts from key urologic and urogynecologic meetings were not included as most do not clearly describe the OMs and definition of success used. Editorials, commentaries, review articles, and metaanalyses were also excluded. The resulting abstracts and full-text articles were read in depth, and articles meeting the inclusion and exclusion criteria were included in the review. Data collected from each publication included type of study, journal in which the study was published, country of origin, study aim, publication data, specific objective, subjective OMs, and specific objective and subjective definitions of success used. Data from the relevant papers were extracted and entered
Table 1 – Questionnaires and criteria used for subjective cure Questionnaire and criteria ICS Grade A recommended questionnaire UDI/UDI-6 ICIQ-short form Incontinence Impact Questionnaire-7 King’s Health Questionnaire ICIQ-FLUTS ICIQ-urinary incontinence Incontinence Severity Index Urinary Incontinence Severity Score Validated but not ICS recommended questionnaire PGI-I Medical Epidemiologic and Social Aspects of Aging Pelvic Floor Disorder Index-20 Quality of life PGI-I-continence PGI-I-severity Not validated/other criteria Subjective home questionnaires Number of pads/d Absence of retreatment 3-d voiding diary Visual analog scale Other
Times used (n)
10 6 3 3 1 1 1 1 12 5 1 1 1 1 12 4 4 2 4 3
ICS = International Continence Society; UDI = Urinary Distress Inventory; ICIQ = International Consultation on Incontinence Modular Questionnaire; FLUTS = female lower urinary tract symptoms; PGI-I = Patient Global Impression of Improvement.
Please cite this article in press as: Carmel ME, et al. Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.03.005
EUF-137; No. of Pages 7 3
EUROPEAN UROLOGY FOCUS XXX (2016) XXX–XXX
in an Excel database. Descriptive statistics were used to report the frequency of use for each OM. We conclude this review with recommendations on the minimal requirement and OMs to be used in future publications reporting outcomes of surgeries for SUI and VD. We provide recommendations for objective and subjective success. These recommendations are based on the most frequent OMs used for the definition of objective and subjective success found in the review, and ICS and ICI recommendations [3]. 3.
Evidence synthesis
The studies were performed in 30 different countries. Most of the publications originated from Europe (n = 53), with 16 from North America and 26 from other countries. There were 52 randomized controlled trials, 38 prospective studies, and five retrospective studies. With regard to the definition of success, most trials reported outcomes at 12 mo after surgery (n = 45, 47%). Thirteen (14%) reported outcomes at 6 mo, 18 (19%) at 18–24 mo, and 19 (20%) at >36 mo (3–17 yr). The majority reported their primary outcomes using both objective and subjective success measures (n = 48), 24 defined success using subjective measures alone, and 23 using objective measures alone.
3.1.
Stress urinary incontinence
3.2.
Our PudMed search identified a total of 168 publications. Of these, 95 articles from 33 different journals and by 86 principal authors met the inclusion and exclusion criteria.
Objective success definition
The number of objective OMs in each study for the definition of efficacy was quite variable, with nine studies using only one OM in the assessment of objective efficacy
Table 2 – Definition of subjective and objective cure as primary outcomes in multicenter randomized controlled trials Study (year)
Country
Randomized procedures
Follow-up (mo)
Van der Ploeg (2015) [6]
12
Laurikainen (2014) [8]
Netherlands Transvaginal prolapse repair with or without MUS Austria/ RMUS vs TMUS Germany Finland RMUS vs TMUS
Labrie (2013) [9]
Netherlands MUS vs PFPT
12
Mostafa (2013) [10]
UK
12
Van Leijsen (2013) [11] Albo (2012) [12]
Single incision sling vs TMUS Netherlands UDS before MUS USA RMUS vs TMUS
Richter (2012) [13]
USA
Burch vs pubovaginal sling
24
Nager (2012) [14]
USA
UDS before MUS
12
Van Leijsen (2012) [15] Barber (2012) [16]
Netherlands UDS before MUS USA Single incision sling vs RMUS Finland RMUS vs TMUS
Aigmu¨ller (2014) [7]
Palva (2011) [17]
Definition of success Subjective Absence of UI on UDI-6 + absence of retreatment for SUI and UUI
3 60
12 24
12 12 36
Andrada Hamer (2011) [18] Sweden Richter (2011) [19] USA
RMUS vs TVT Secur RMUS vs TMUS
2 12
Ballester (2012) [20]
France
RMUS vs TMUS
48
Hinoul (2011) [21]
Meschia (2010) [24]
Italy
Deffieux (2010) [25]
France
Single incision sling vs TMUS RMUS vs TMUS TVT vs Pelvicol vs fascial sling Single incision sling vs TMUS RMUS vs TMUS
12
Freeman (2011) [22] Guerrero (2010) [23]
Belgium/ Netherlands UK UK
12 1.5
Objective
Negative CST + stable cystometry at 300 cm3 Negative CST + negative 24-h pad test + no retreatment
Patient satisfaction on home-made questionnaire Much improved and very much improved on PGI-I Much improved and very much improved on PGI-I Improvement of UDI-11 score No self-reported SUI symptoms + no Negative CST + negative SUI on 3-d voiding diary + no 24-h pad test + no retreatment retreatment No incontinence on 3-d voiding No retreatment diary + no SUI on MESA + no retreatment 70% improvement in UDI-20 + much improved/very much improved on PGI-I Improvement in UDI-6 score ISI of 0 + no retreatment Improvement in UDI-6 and detrusor instability score Self-reported cure or improved No SUI on MESA + no SUI on 3-d voiding diary + no retreatment
Negative CST + negative 24-h pad test + no retreatment Negative CST + no SUI on UDS + no urinary retention + PVR
available at www.sciencedirect.com journal homepage: www.europeanurology.com/eufocus
Review – Female Urology – Incontinence
Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization Maude E. Carmel a,*, Donna Y. Deng b, Tamsin J. Greenwell c, Philippe E. Zimmern a a
University of Texas Southwestern, Dallas, TX, USA; b University of California San Francisco, San Francisco, CA, USA; c University College London Hospitals,
London, UK
Article info
Abstract
Article history: Accepted March 14, 2016
Context: There is currently no standardized definition of success for surgery for stress urinary incontinence (SUI) and voiding dysfunction (VD) in women. Objective: To review the use of outcome measures (OMs) and definitions of success in the literature on SUI and VD surgery in women in an attempt to provide recommendations for future publications. Evidence acquisition: A PubMed search of all English language full-text articles on SUI and VD surgery in women published between 2010 and 2015 was performed. A list of randomized trials and prospective and retrospective studies was obtained. Specific objective and subjective OMs used to define success were reviewed. Evidence synthesis: Some 95 articles met the inclusion criteria for SUI surgery outcomes. Most trials reported outcomes at 12 mo after surgery. The majority (n = 48) reported their primary outcomes using both objective and subjective success measures, 24 defined success using subjective OMs alone, and 23 using objective OMs alone. The OMs most frequently used for objective success were a negative cough stress test (CST), a negative pad test, and the absence of retreatment for SUI. The definition of subjective success most often involved questionnaires. The questionnaires most frequently used were Patient Global Impression of Improvement (PGI-I), Urinary Distress Inventory (UDI)/UDI-6, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and Medical Epidemiologic and Social Aspects of Aging (MESA). Only 11 studies on OMs used for VD surgery were published between 2010 and 2015. The two most common criteria used for success were measurement of postvoid residual urine (PVR) and subjective resolution of VD symptoms. Conclusions: There is great heterogeneity in the definition of success used after surgery for SUI or VD in women. For SUI surgery, we recommend use of the CST and a 1-h pad test for the definition of objective success, and of the UDI/UDI-6, Incontinence Impact Questionnaire (IIQ), King’s Health Questionnaire (KHQ), ICIQ-SF, or PGI-I questionnaire for subjective success. For VD surgery, cure should include measurement of PVR and selfreported resolution of VD symptoms. Patient summary: We looked at the definition of success used for surgery for stress urinary incontinence (SUI) and voiding dysfunction (VD) in women. We found that there is great heterogeneity among studies, making study comparison extremely difficult. According to the outcome measures used most frequently, we make recommendations regarding the definition of cure for SUI and VD in women to be used in future publications. # 2016 Published by Elsevier B.V. on behalf of European Association of Urology.
Associate Editor: James Catto Keywords: Outcome measures Stress urinary incontinence Voiding dysfunction
* Corresponding author. University of Texas Southwestern, 5323 Harry Hines Boulevard, Dallas, TX 75390-9110, USA. Tel. +1 214 6486333; Fax: +1 214 6488786. E-mail address: [email protected] (M.E. Carmel).
http://dx.doi.org/10.1016/j.euf.2016.03.005 2405-4569/# 2016 Published by Elsevier B.V. on behalf of European Association of Urology.
Please cite this article in press as: Carmel ME, et al. Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.03.005
EUF-137; No. of Pages 7 2
EUROPEAN UROLOGY FOCUS XXX (2016) XXX–XXX
1.
Introduction
There is currently no standardized definition of success for surgery for stress urinary incontinence (SUI) and voiding dysfunction (VD) in women. This makes it very challenging to compare different procedures owing to the wide heterogeneity among the outcome variables used. There have been a few recent attempts to develop both core and minimum outcome sets to be reported in every study to provide consistent evidence from which to draw meaningful conclusions. The last Cochrane review of minimally invasive midurethral sling operations for the treatment of SUI noted that the variable quality of evidence presented limited the ability to make strong recommendations [1]. The need for more robustly designed randomized controlled trials with standardized objective and validated subjective outcomes was highlighted. Reporting both subjective and objective outcomes is extremely important because of the well-known discrepancies between clinical and objective measures recorded by physicians and the subjective perception of symptoms by patients [2]. The International Continence Society (ICS) and the 4th International Consultation on Incontinence (ICI) previously published a list of recommended outcome measures (OMs) for incontinence therapy, including a list of subjective and objective outcomes [3]. Grade A, ‘‘highly recommended’’ questionnaires were those with well-published data proving their validity, reliability, and responsiveness to change. The use of highquality questionnaires was strongly recommended for assessing both a patient’s perspective of symptoms and their impact on quality of life. Unfortunately, most recent studies have not followed these guidelines and significant inconsistency in OM reporting remains. Definitions of cure and improvement or failure are also extremely variable, with most relying on unvalidated questionnaires and patient selfassessment. This makes useful comparisons between published studies very difficult, if not impossible. Multiple reports have demonstrated the need for a consensus and standardization in the choice of OMs used for reporting of anti-incontinence and VD procedures [1,4,5]. The aim of this study was to review the use of OMs and definition of success in the literature on SUI and VD surgery in an attempt to provide much-needed recommendations and to gain some consensus for future publications. 2.
Evidence acquisition
We conducted a literature search in September 2015 using the PubMed database. Filters were applied to capture only full-length articles published in English between January 2010 and September 2015. We limited our search to the past 5 yr in an effort to base our recommendations on the most recent data available. We included articles reporting on outcomes of surgery for SUI and for incomplete emptying, urinary retention, and VD. The surgeries of interest for the treatment of SUI were sling procedures (midurethral sling, mini-sling and pubovaginal slings), Burch and Marshall-Marchetti-Krantz urethropexy, and needle suspensions. The following search was
performed: ‘‘stress urinary incontinence’’ AND ‘‘surgery’’ AND ‘‘women’’. A filter term for clinical trials was also used. Surgeries for the treatment of VD and incomplete emptying were sling excision or revision or incision, urethrolysis, and bladder neck incision. The following searches were performed: ‘‘women’’ AND ‘‘primary bladder neck obstruction’’; ‘‘sling excision’’ AND ‘‘women’’; ‘‘sling incision’’ AND ‘‘women’’; ‘‘urinary retention’’ AND ‘‘surgery’’ AND ‘‘women’’; ‘‘voiding dysfunction’’ AND ‘‘surgery’’ AND ‘‘women’’. We excluded articles reporting outcomes for patients with pelvic organ prolapse (unless outcomes for SUI were well defined) or neurogenic bladder, and for incontinence in men, children and pregnant women. Outcomes of treatments for urgency urinary incontinence were excluded from this review as its management is mostly nonsurgical and the success criteria used for sacral nerve neuromodulation are already well established. Bulking agents were also excluded from this review to focus only on open and vaginal surgical treatments for SUI. Abstracts from key urologic and urogynecologic meetings were not included as most do not clearly describe the OMs and definition of success used. Editorials, commentaries, review articles, and metaanalyses were also excluded. The resulting abstracts and full-text articles were read in depth, and articles meeting the inclusion and exclusion criteria were included in the review. Data collected from each publication included type of study, journal in which the study was published, country of origin, study aim, publication data, specific objective, subjective OMs, and specific objective and subjective definitions of success used. Data from the relevant papers were extracted and entered
Table 1 – Questionnaires and criteria used for subjective cure Questionnaire and criteria ICS Grade A recommended questionnaire UDI/UDI-6 ICIQ-short form Incontinence Impact Questionnaire-7 King’s Health Questionnaire ICIQ-FLUTS ICIQ-urinary incontinence Incontinence Severity Index Urinary Incontinence Severity Score Validated but not ICS recommended questionnaire PGI-I Medical Epidemiologic and Social Aspects of Aging Pelvic Floor Disorder Index-20 Quality of life PGI-I-continence PGI-I-severity Not validated/other criteria Subjective home questionnaires Number of pads/d Absence of retreatment 3-d voiding diary Visual analog scale Other
Times used (n)
10 6 3 3 1 1 1 1 12 5 1 1 1 1 12 4 4 2 4 3
ICS = International Continence Society; UDI = Urinary Distress Inventory; ICIQ = International Consultation on Incontinence Modular Questionnaire; FLUTS = female lower urinary tract symptoms; PGI-I = Patient Global Impression of Improvement.
Please cite this article in press as: Carmel ME, et al. Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.03.005
EUF-137; No. of Pages 7 3
EUROPEAN UROLOGY FOCUS XXX (2016) XXX–XXX
in an Excel database. Descriptive statistics were used to report the frequency of use for each OM. We conclude this review with recommendations on the minimal requirement and OMs to be used in future publications reporting outcomes of surgeries for SUI and VD. We provide recommendations for objective and subjective success. These recommendations are based on the most frequent OMs used for the definition of objective and subjective success found in the review, and ICS and ICI recommendations [3]. 3.
Evidence synthesis
The studies were performed in 30 different countries. Most of the publications originated from Europe (n = 53), with 16 from North America and 26 from other countries. There were 52 randomized controlled trials, 38 prospective studies, and five retrospective studies. With regard to the definition of success, most trials reported outcomes at 12 mo after surgery (n = 45, 47%). Thirteen (14%) reported outcomes at 6 mo, 18 (19%) at 18–24 mo, and 19 (20%) at >36 mo (3–17 yr). The majority reported their primary outcomes using both objective and subjective success measures (n = 48), 24 defined success using subjective measures alone, and 23 using objective measures alone.
3.1.
Stress urinary incontinence
3.2.
Our PudMed search identified a total of 168 publications. Of these, 95 articles from 33 different journals and by 86 principal authors met the inclusion and exclusion criteria.
Objective success definition
The number of objective OMs in each study for the definition of efficacy was quite variable, with nine studies using only one OM in the assessment of objective efficacy
Table 2 – Definition of subjective and objective cure as primary outcomes in multicenter randomized controlled trials Study (year)
Country
Randomized procedures
Follow-up (mo)
Van der Ploeg (2015) [6]
12
Laurikainen (2014) [8]
Netherlands Transvaginal prolapse repair with or without MUS Austria/ RMUS vs TMUS Germany Finland RMUS vs TMUS
Labrie (2013) [9]
Netherlands MUS vs PFPT
12
Mostafa (2013) [10]
UK
12
Van Leijsen (2013) [11] Albo (2012) [12]
Single incision sling vs TMUS Netherlands UDS before MUS USA RMUS vs TMUS
Richter (2012) [13]
USA
Burch vs pubovaginal sling
24
Nager (2012) [14]
USA
UDS before MUS
12
Van Leijsen (2012) [15] Barber (2012) [16]
Netherlands UDS before MUS USA Single incision sling vs RMUS Finland RMUS vs TMUS
Aigmu¨ller (2014) [7]
Palva (2011) [17]
Definition of success Subjective Absence of UI on UDI-6 + absence of retreatment for SUI and UUI
3 60
12 24
12 12 36
Andrada Hamer (2011) [18] Sweden Richter (2011) [19] USA
RMUS vs TVT Secur RMUS vs TMUS
2 12
Ballester (2012) [20]
France
RMUS vs TMUS
48
Hinoul (2011) [21]
Meschia (2010) [24]
Italy
Deffieux (2010) [25]
France
Single incision sling vs TMUS RMUS vs TMUS TVT vs Pelvicol vs fascial sling Single incision sling vs TMUS RMUS vs TMUS
12
Freeman (2011) [22] Guerrero (2010) [23]
Belgium/ Netherlands UK UK
12 1.5
Objective
Negative CST + stable cystometry at 300 cm3 Negative CST + negative 24-h pad test + no retreatment
Patient satisfaction on home-made questionnaire Much improved and very much improved on PGI-I Much improved and very much improved on PGI-I Improvement of UDI-11 score No self-reported SUI symptoms + no Negative CST + negative SUI on 3-d voiding diary + no 24-h pad test + no retreatment retreatment No incontinence on 3-d voiding No retreatment diary + no SUI on MESA + no retreatment 70% improvement in UDI-20 + much improved/very much improved on PGI-I Improvement in UDI-6 score ISI of 0 + no retreatment Improvement in UDI-6 and detrusor instability score Self-reported cure or improved No SUI on MESA + no SUI on 3-d voiding diary + no retreatment
Negative CST + negative 24-h pad test + no retreatment Negative CST + no SUI on UDS + no urinary retention + PVR
