A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set.

In total, 2482 titles and abstracts were screened, and 231 potentially relevant studies were examined in detail (Fig.  1 ). Sixty-eight randomised trials, reporting data from 10,499 participants, met the inclusion criteria (Table 1 ) [ 5 , 10 – 88 ]. Additionally, 12 randomised trials published long-term follow-up data [ 5 , 22 , 29 , 39 , 40 , 64 , 71 , 72 , 79 , 81 , 86 , 87 ] Fig. 1 Study search and inclusion Table 1 Study characteristics Author Study year Journal Impact factor Journal type 3 Jadad score MOMENT score Study size Commercial funding Validated questionnaire use Intervention group 1 Intervention group 2 Intervention group 3 Intervention group 4 Altman et al. a 2011 New England Journal of Medicine 29.1 G 4 5 389 Yes Yes Anterior colporrhaphy Transvaginal mesh repair Antosh et al. 2013 Obstetrics and Gynaecology 4.78 S 3 6 60 No Yes Use of dilators post prolapse surgery Non-use of dilators post prolapse surgery Ballard et al. 2014 International Urogynecology Journal 2.17 G 5 5 150 No Yes Preop. bowel preparation Preop. non bowel preparation Benson et al. 1996 American Journal of Obstetrics and Gynaecology – S 3 3 80 No No Pelvic surgery for prolapse Abdominal surgery Borstad et al. a 2009 International Urogynecology Journal 2.84 SS 3 4 184 No No Anterior colporrhaphy TVT Anterior colporrhaphy + TVT staged procedure Bray et al. 2017 European Journal of Obstetrics & Gynaecology and Reproductive Biology N/A G 3 5 60 No N/A Suprapubic catheter Immediate removal of catheter Carey et al. 2009 British Journal of Obstetrics and Gynaecology 4.64 S 3 5 139 Yes Yes Conventional vaginal repair Mesh vaginal repair Choe et al. a 2000 Journal of Urology 2.64 SS 2 3 40 No Yes Antilogous vaginal wall slings Micromesh Colombo et al. a 2000 British Journal of Obstetrics and Gynaecology 4.64 S 3 3 71 No No Anterior colporrhaphy Burch colposuspension da Silveira et al. 2014 International Urogynecology Journal 2.17 SS 3 5 184 Yes Yes Native tissue repair Synthetic mesh repair Dahlgren et al. 2011 Acta Obstetricia et Gynecologica Scandinavica 2.2 S 3 3 135 No Yes Conventional colporrhaphy Porcine skin graft Delroy et al. a,b 2013 International Urogynecology Journal 2.45 SS 5 6 79 Yes Yes Anterior colporrhaphy Transvaginal mesh repair Dias et al. a,c 2016 Neurourology and Urodynamics 2.48 SS 5 6 88 No Yes Anterior colporrhaphy Transvaginal mesh repair de Tayrac et al. a 2012 International Urogynecology Journal 2.53 SS 3 5 147 No Yes Anterior colporrhaphy Transvaginal mesh repair Ek et al. a 2012 International Urogynecology Journal 2.53 SS 2 4 99 No Yes Anterior trocar-guided transvaginal mesh repair Anterior colporrhaphy with lateral defects repair Ek et al. a 2010 Neurourology and Urodynamics 3.01 SS 5 4 50 No N/A Anterior colporrhaphy Trocar guided transvaginal mesh repair El-Nazer et al. a 2012 American Journal of Obstetrics and Gynaecology 1.56 S 5 5 44 No Yes Anterior colporrhaphy Transvaginal mesh repair Farthmann et al. a 2013 International Urogynecology Journal 2.45 SS 3 3 200 Yes Yes Conventional anterior colporrhaphy Partially absorbable mesh Feldner et al. a,b 2010 International Urogynecology Journal 2.66 SS 5 5 56 Yes Yes Anterior colporrhaphy SIS graft Feldner et al. a,c 2012 Clinical Science 5.87 G 5 4 56 No Yes Small intestine submucosa graft Traditional colporrhaphy Galvind et al. 2007 Acta Obstetricia et Gynecologica Scandinavica 1.94 G 3 2 136 No N/A 3-h catheterisation and vaginal tampon 24-h catheterisation and vaginal tampon Gandhi et al. a 2005 American Journal of Obstetrics and Gynaecology 4 S 3 5 154 No No Anterior colporrhaphy Colporrhaphy and fascial patch Geller et al. 2011 British Journal of Obstetrics and Gynaecology 4.34 S 3 4 50 No N/A Spontaneous postop. micturition Micturition after bladder refill Glazener et al. b 2017 The Lancet N/A G 3 6 1352 No Yes Standard repair Mesh repair Biological graft Glazener et al. c 2017 Health Technology Assessment N/A G 4 6 3087 No Yes Standard repair Mesh repair Biological graft Guerette et al. a 2009 Obstetrics and Gynaecology 4.69 S 4 4 94 Yes Yes Anterior repair Anterior repair + porcine graft mesh Gupta et al. a 2014 South African Journal of Obstetrics & Gynaecology 0.23 S 3 4 106 No N/A Anterior repair Anterior repair + mesh Hakvoort 2004 British Journal of Obstetrics and Gynaecology 4.75 S 2 3 100 No N/A 4-day catheterisation 1-day catheterisation Henn et al. 2016 International Urogynecology Journal 1.83 SS 5 6 80 No N/A Vaginal vasoconstrictor infiltration Vaginal saline infiltration Hiltunen et al. a,b 2007 Obstetrics and Gynaecology 4.45 G 3 4 202 No No Anterior colporrhaphy Transvaginal mesh repair Nieminen et al. a,c 2010 American Journal of Obstetrics and Gynaecology 4.98 G 3 4 202 No No Anterior colporrhaphy Transvaginal mesh repair Nieminen et al. a,c 2008 International Urogynecology Journal 2.51 SS 3 2 202 No No Anterior colporrhaphy Transvaginal mesh repair Huang et al. 2010 International Urogynecology Journal 2.66 SS 3 3 90 No N/A Removal of catheter on day 2 postop. Removal of catheter on day 3 postop. Removal of catheter on day 4 postop. Hviid et al. a 2010 International Urogynecology Journal 2.66 SS 3 3 61 No Yes Conventional anterior repair Anterior repair + porcine skin collagen implants Iglesia et al. 2010 Obstetrics and Gynaecology 4.98 S 5 6 65 No Yes Conventional colporrhaphy or uterosacral ligament suspension Vaginal colpopexy with mesh Kamilya et al. 2010 Journal of Obstetrics and Gynaecology Research 1.13 S 3 6 200 No N/A Catheter removal day 4 postop. Catheter removal day 1 postop. Khalil et al. 2016 Journal of Clinical Anaesthesia 1.64 S 5 5 57 No No General anaesthesia General anaesthesia + pudendal nerve block Kringel et al. a 2010 International Urogynecology Journal 2.66 SS 3 5 232 No N/A Intraurethral catheterisation 24 h Intraurethral catheterisation 96 h Suprapubic catheterisation 96 h Lambin et al. a 2013 International Urogynecology Journal 2.45 SS 3 5 68 No Yes Anterior colporrhaphy with vaginal colposuspension Transvaginal mesh repair Lazzeri et al. a 2007 Journal of Urology 4.27 S 3 5 47 No Yes Abdominal prolapse repair NO Burch colposuspension Abdominal prolapse repair and Burch colposuspension Lindholm et al. 1985 International Journal of Gynaecology and Obstetrics N/A S 4 3 20 No N/A Phenoxybenzamine use Control Mahuvrata et al. 2011 Journal of Obstetrics and Gynaecology 0.75 G 5 5 66 No Yes Mesh repair No mesh PDS Vicryl McNanley et al. 2012 Female Pelvic Medicine & Reconstructive Surgery 0.42 SS 3 6 60 No Yes Docusate sodium laxative postoperative Other laxatives postoperative Menefee et al. a 2011 Obstetrics and Gynaecology 5.34 S 5 6 99 Yes Yes Anterior colporrhaphy Mesh repair Biological graft Meschia et al. a 2003 American Journal of Obstetrics and Gynaecology 2.96 S 3 5 50 No No Endopelvic fascia plication TVT + Anterior repair Minassian et al. a 2014 Neurourology and Urodynamics 2.71 SS 3 5 70 No Yes Conventional anterior colporrhaphy Abdominal paravaginal defect repair Miranda et al. a 2011 Journal of obstetrics and gynaecology Canada 1.42 S 5 2 22 No N/A Anterior colporrhaphy with polyglactin 910 mesh Anterior colporrhaphy without plication of pubovesical fascia Natale et al. a 2009 International Urogynecology Journal 2.84 SS 3 5 190 No Yes Anterior colporrhaphy Synthetic mesh Park et al. a 2013 International Urogynecology Journal 2.45 SS 3 5 92 No Yes Anterior repair + TVT TVT Pauls et al. 2015 American Journal of Obstetrics and Gynaecology 5.23 S 5 5 74 No Yes Dexamethasone prior to surgery Placebo Ploege et al. 2015 International Urogynecology Journal 1.83 SS 3 6 91 Yes Yes Prolapse surgery Prolapse surgery + TVT Qatawneh et al. 2013 Gynaecological Surgery 0.46 S 3 5 116 No No Native tissue repair Mesh repair Quadri et al. a 2000 International Urogynecology Journal 1.15 SS 3 3 45 No N/A Use of PGE-2 Control Robert et al. a 2014 Obstetrics and Gynaecology 4.76 S 5 4 57 Yes Yes Anterior colporrhaphy Transvaginal mesh repair Rudnicki et al. a,b 2013 British Journal of Obstetrics and Gynaecology 2.9 G 3 5 160 No Yes Anterior colporrhaphy Transvaginal mesh repair Rudnicki et al. a,c 2015 British Journal of Obstetrics and Gynaecology 2.9 G 3 3 138 No Yes Anterior colporrhaphy Transvaginal mesh repair Sand et al. 2001 American Journal of Obstetrics and Gynaecology 2.72 S 3 4 161 No N/A Conventional anterior colporrhaphy Use of mesh Schierlitz et al. 2013 International Urogynecology Journal 2.45 SS 3 5 80 No Yes Conventional pelvic repair Conventional pelvic repair + TVT Segal et al. 2006 International Urogynecology Journal 2.38 SS 3 5 40 No No Local anaesthesia General anaesthesia Sivaslioglu et al. a 2007 International Urogynecology Journal 2.79 SS 3 2 90 No Yes Anterior colporrhaphy Transvaginal mesh repair Stekkinger et al. 2011 Gynecologic and Obstetric investigation 1.74 G 3 5 126 No N/A Trans urethral catheter S/pubic catheter Tamanini et al. a,b 2012 International Braz J Urol: official journal of the Brazilian Society of Urology 1.24 G 4 5 100 No Yes Anterior colporrhaphy Transvaginal mesh repair Tamanini et al. a,c 2012 International Braz J Urol: official journal of the Brazilian Society of Urology 1.24 G 4 5 100 No Yes Anterior colporrhaphy Transvaginal mesh repair Tamanini et al. a,c 2014 Journal of Urology 4.68 S 4 5 92 No Yes Anterior colporrhaphy Transvaginal mesh repair Tantanasis et al. a 2008 Acta Obstetricia et Gynecologica Scandinavica 1.72 S 2 2 50 No No Anterior colporrhaphy Bladder base tape repair Thiagamoorthy et al. 2013 International Urogynecology Journal 2.45 SS 5 6 190 No N/A Use of postop. vaginal pack No use of postop. vaginal pack Tincello et al. a 2009 British Journal of Obstetrics and Gynaecology 4.18 S 3 4 31 No Yes Colposuspension + anterior repair TVT + Anterior repair Turgal et al. a 2013 European Journal of Obstetrics & Gynaecology and Reproductive Biology 2.4 G 3 2 40 No No Anterior colporrhaphy Transvaginal mesh repair Van et al. 2011 International Urogynecology Journal 2.39 SS 3 5 179 No N/A 1-day suprapubic catheterisation 3-day suprapubic catheterisation Vollebregt et al. a,b 2011 British Journal of Obstetrics and Gynaecology 2.96 S 5 6 125 No Yes Anterior colporrhaphy Transvaginal mesh repair Vollebregt et al. a,c 2012 Journal of Sexual Medicine 3.67 SS 5 6 125 No Yes Anterior colporrhaphy Transvaginal anterior or posterior mesh repair Weber et al. a,b 2001 American Journal of Obstetrics and Gynaecology 2.72 G 2 3 114 No No Unilateral anterior colporrhaphy Anterior colporrhaphy Transvaginal mesh repair Chmielewski et al. a,c 2011 American Journal of Obstetrics and Gynaecology 5.34 G 4 4 114 No No Unilateral anterior colporrhaphy Anterior colporrhaphy Transvaginal mesh repair Weemhoff et al. a 2011 International Urogynecology Journal 2.39 SS 3 6 246 No N/A Postop. catheterisation for 2 days Postop. catheterisation for 5 days Wei et al. a 2012 New England Journal of Medicine 29.36 G 5 6 337 No Yes Anterior repair TVT + Anterior repair Westermann et al. 2016 Female Pelvic Medicine & Reconstructive Surgery 1.49 SS 4 5 93 No Yes Use of postop. vaginal pack No use of postop. vaginal pack Withagen et al. b 2011 Obstetrics and Gynaecology 5.34 S 5 6 194 No Yes Conventional colporrhaphy Transvaginal mesh repair Withagen et al. c 2011 British Journal of Obstetrics and Gynaecology 4.34 S 5 6 59 No Yes Conventional colporrhaphy Transvaginal mesh repair Milani et al. c 2011 Journal of Sexual Medicine 3.67 SS 3 6 59 No Yes Conventional colporrhaphy Trocar-guided Mesh Yuk et al. a 2012 Journal of Minimally Invasive Gynaecology 2.1 S 3 3 87 No N/A 2-point mesh 4-point mesh SS subspecialty (urogynaecology), S specialty (obs/gyn), G general, TVT tension free vaginal tape (retropubic tape), PDS polydioxanone a Studies focused on surgical management of anterior repair solely, b original study, c secondary analysis . Study search and inclusion Study characteristics SS subspecialty (urogynaecology), S specialty (obs/gyn), G general, TVT tension free vaginal tape (retropubic tape), PDS polydioxanone a Studies focused on surgical management of anterior repair solely, b original study, c secondary analysis Trials were published between 1985 and 2017, with most being published in subspecialty journals (33/80; 41%). Trials were frequently published in journals with an impact factor <3 [median = 2.7; interquartile range (IQR) = 2.2–4.3] and were generally small (median = 93; IQR = 60–154). Ten trials (14%) declared commercial funding. The methodological quality and outcome reporting quality varied considerably between trials (Table 1 ). One hundred different outcomes were organised into 11 thematic domains. The three most commonly reported thematic domains were presence of symptoms posttreatment (50 trials, 28 outcomes; 28 outcome measures), prolapse treatment success rates (47 trials; 3 outcomes; 16 outcome measures) and perioperative complications (46 trials; 15 outcomes; 13 outcome measures) (Table 2 ). Commonly reported outcomes were anatomical prolapse stage (43 trials; 54%), commonly assessed using the Pelvic Organ Prolapse Quantification (POP-Q) instrument (35 trials; 81%), QoL (25 trials; 31%); and intra- and postoperative complications (23 trials; 29%). Patient-reported outcomes were infrequently reported; for example, a minority of trials reported prolapse symptoms (9 trials; 11%), urinary symptoms (11 trials; 14%) and sexual dysfunction (14 trials; 17%) (Table 3 ). Eleven trials (14%) reported patient satisfaction. Table 2 Most commonly reported outcome domains Outcome domains RCTs reporting on the domain Outcomes reported Outcome measures reported Presence of symptoms posttreatment 50 28 28 Prolapse treatment success rate 47 3 16 Perioperative complications and observations 46 15 13 Quality of life and satisfaction with treatment 40 5 25 Treatment success evaluation 15 11 – Postoperative catheterisation 10 17 10 Pain 9 4 7 Mesh-related outcomes 8 3 – RCT randomised controlled trial Table 3 Outcomes reported in 80 randomised controlled trials (RCTs) evaluating surgical management of anterior-compartment prolapse Outcomes Reporting studies Prolapse treatment success rate Anatomical prolapse stage 43 Composite anatomical/functional success rate 3 Urethral mobility 1 Perioperative complications and observations Complications intra-/postoperatively 23 Postoperative hospital stay length 11 Blood loss intraoperatively 6 Duration of operation 6 Quality and time of recovery 4 Postoperative nausea and vomiting 3 Bleeding postoperatively (with/out vaginal pack use) 2 Constipation preoperatively 2 Blood pressure 2 Blood transfusion indicated 2 Heart rate change 2 Consistency of bowel movement postoperatively 1 Intra- and postoperative morbidity 1 Time to first postoperative bowel movement 1 Time to mobilisation 1 Pain Postoperative pain 8 Intraoperative requirement of analgesics 1 Total analgesic consumption 1 Pain level associated with first postoperative bowel movement 1 Postoperative catheterisation Postoperative UTI 5 Recatheterisation rates 5 Postoperative catheterisation duration 4 First postvoid residual volume 4 Time to normal spontaneous voiding 2 Acute urinary retention 1 Bacterial count in the urine 1 Catheter blockage 1 Day of spontaneous voiding 1 Diagnostic accuracy of different voiding trial methods 1 Mean residual urine volume pre- and postoperatively 1 Prediction of voiding dysfunction lasting >7 days. 1 Prolonged catheterisation 1 Pyelectasia 1 Residual urine volume 1 Urinary retention prevention with intravesically administered prostaglandin-E2 1 Urinary retention rates 1 Postoperative vaginal packing Bleeding postoperatively (with/out vaginal pack use) (compared with menstrual average) 1 Bleeding postoperatively (with/out vaginal pack use) 1 Presence of vaginal haematoma 1 Presence of vaginal infection 1 Bother related to the pack 1 Presence of symptoms posttreatment Sexual dysfunction symptoms 14 Urinary symptoms 11 Prolapse symptoms postoperatively 9 Dyspareunia 6 SUI postoperatively 5 De novo SUI postoperatively 4 Change in urinary symptoms (any) 3 Prolapse symptoms severity 3 De novo urinary urgency 2 Postoperative urinary symptoms 2 Urinary symptoms severity 2 Bowel symptoms 2 Faecal incontinence 2 Postoperative bowel symptoms 2 Change in incontinence rates 1 De novo urinary symptoms 1 De novo voiding difficulty 1 Urgency and urge urinary incontinence 1 Worsening urinary symptoms (any) 1 Obstructed defecation 1 Back pain improvement 1 Change in a pelvic symptom score 1 Change of vaginal symptoms 1 Symptomatic prolapse improvement 1 Time of prolapse recurrence 1 De novo dyspareunia 1 Sexual function in partner 1 QoL and satisfaction with treatment QoL and impact from symptoms evaluation 25 Patient satisfaction with treatment 11 Surgeon satisfaction with operation 2 Patient acceptability of preoperative bowel preparation 1 Surgeon—ease of procedure 1 Treatment success evaluation Symptoms—presence posttreatment 5 Subjective cure rates 3 Cure of SUI postoperatively 3 Reoperation rates 3 Symptoms—bother change 2 Retreatment success rates 1 Symptom improvement 1 Functional recurrence 1 Healing abnormalities 1 Need for subsequent anti-incontinence surgery 1 Treatment of overactive bladder 1 Mesh-related outcomes Mesh erosion 6 Mesh shrinkage 2 Degree of morbidity in mesh vs. native tissue 1 Cost/effectiveness Cost-effectiveness of treatment 2 Cost of procedure 1 Recruitment feasibility Number of patients agreed to participate 1 Number of eligible patients 1 Physician acceptance and protocol 1 Rate of recruitment compliance 1 UTI urinary tract infection, SUI stress urinary incontinence, QoL quality of life Most commonly reported outcome domains RCT randomised controlled trial Outcomes reported in 80 randomised controlled trials (RCTs) evaluating surgical management of anterior-compartment prolapse UTI urinary tract infection, SUI stress urinary incontinence, QoL quality of life Forty-two randomised trials compared native tissue or biological graft versus mesh repair for anterior vaginal prolapse. Mesh-related complications were rarely reported: seven trials (9%) reported mesh erosion, six (7%) reported mesh shrinkage and a single trial (1%) reported the degree of morbidity associated with mess Only three trials (4%) evaluated cost effectiveness. One hundred and twelve different outcome measures wer reported (Table 4 ). Forty-six questionnaires were used as measurement instruments, most of which were validated (45; 98%). Anterior prolapse symptoms were measured using the Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire (PISQ-12) (13 trials; 16%), Urogenital Distress Inventory (UDI-6) (11 trials; 14%) and the Pelvic Floor Distress Inventory (PFDI-20) (9 trials; 11%). QoL was measured using the Prolapse Quality of Life (P-QoL) (10 trials; 12%), Pelvic Floor Impact Questionnaire Short Form (PFIQ-7) (8 trials; 10%) and the Incontinence Impact Questionnaire Short Form (IIQ-7) (6 trials; 7%). Table 5 summarises our main findings, demonstrating the most frequently reported outcomes. It reveals the significant discrepancies in terms of outcome reporting. Table 4 Outcome measures reported in 80 randomised controlled trials (RCTs) evaluating surgical management of anterior-compartment prolapse Outcomes No of reporting studies Prolapse treatment success rate Anatomical success rate POP-Q < 2 23 Anatomical success rate (POP-Q ≤ 1) 5 Anatomical success rate (postoperative POP-Q stage improvement) 5 Anatomical success rate (POP above hymen) 3 Anatomical success rate POP-Q ≤ 2 2 Anatomical success rate (POP-Q < 2 vs. POP-Q ≤ 1) 1 Anatomical success rate POP-Q Index (POP-Q-I) = 0 1 Anatomical success rate (postoperative POP-Q + BW stage improvement) 1 Anatomical success rate (cotton swab mobility test) 1 Composite success rate (POP-Q 20 (0–100 scale)) 1 Composite success rate - (POP above hymen + no symptoms) 1 Composite success rate - (apex below levator plate + no symptoms) 1 Denovo POP in untreated compartments (POP-Q ≥ 2) 1 Denovo POP in untreated compartments (POP ≥ hymen) 1 Recurrence rate of POP (halfway BW stage change) 1 Perioperative complications and observations Postoperative hospital stay length (days) 11 Blood loss (ml) 8 Duration of operation (min) 6 PONV (postoperative nausea and vomiting), visual analogue scale [VAS (0–10)] 2 PONV scale 2 PONV QoR (quality of recovery) score > 50 2 Recovery time (days) 2 PONV intensity score [QoR (0–40)] 1 Blood pressure (mmHg) 1 Heart rate (beats/min) 1 Consistency of bowel movement (Bristol stool scale) 1 Constipation perioperatively (Rome III constipation questionnaire) 1 Time to mobilisation (days) 1 Pain VAS (0–10) 5 VAS (0–100) 2 VAS (not specified) 2 Mcgill pain questionnaire 2 Verbal numerical pain scale (0–10) 1 Baudelocque’s questionnaire 1 Nonvalidated questionnaire (0–3) 1 Postoperative catheterisation Postoperative catheterisation duration (days) 4 Day of spontaneous voiding (days) 3 Bacterial count in the urine 1 Residual urine volume (ml) 1 First PVR (postvoid residual volume) > 150 ml 1 First PVR > 1500 ml 1 Mean residual urine volume pre- and postoperatively (ml) 1 Recatheterisation if PVR >200 ml 1 Prediction of voiding dysfunction >7 days (positive predictive value) 1 Diagnostic accuracy of two voiding trial methods (sensitivity/specificity) 1 Postoperative vaginal packing Bleeding postoperatively (with/out vaginal pack use) (compared with menstrual average) 1 Bleeding postoperatively (with/out vaginal pack use) [FBC change and volume (ml)] 1 Blood pressure (mmHg) 1 Heart rate (beats/min) 1 Blood transfusion indicated (yes/no) 1 Vaginal haematoma (TVUSS) 1 Vaginal infection (HVS) 1 Bother related to the pack (VAS 0–100) 1 Presence of symptoms posttreatment PISQ-12 (Pelvic Organ Prolapse Urinary Incontinence–Sexual Questionnaire) 13 UDI-6 (Urogenital Distress Inventory) 11 PFDI-20 (Pelvic Floor Distress Inventory) 9 SUI urodynamic studies 7 DDI (Defecatory Distress Inventory) 5 ICIQ-UI SF (International Consultation on Incontinence Questionnaire–Short Form) 4 SUI cough test (presence of leakage) 4 FSFI (Female Sexual Function Index) 2 ICIQ-BS (International Consultation on Incontinence Questionnaire–Bowel Symptoms) 2 PGI-I (Patient Global Impression of Improvement) 2 OAB-V8 (Overactive Bladder-Validated 8-question) 2 POPDI-6 (Pelvic Organ Prolapse Distress Inventory) 2 POP-SS (Pelvic Organ Prolapse Severity of Symptoms) 2 UDI-I (Urogenital Distress Inventory–Irritative) 2 UDI-O (Urogenital Distress Inventory-Obstructive) 2 UDI-S (Urogenital Distress Inventory–Stress) 2 AUASS [American Urological Association Symptom Score (urinary)] 1 CRADI-8 (Colorectal–Anal Distress Inventory) 1 CRAIQ-7 (Colorectal–Anal Impact Questionnaire) 1 Danish prolapse questionnaire 1 ICIQ-VS (International Consultation on Incontinence Questionnaire–Vaginal Symptoms) 1 MESAAQ (Medical Epidemiologic and Social Aspects of Ageing Questionnaire) 1 MHU (French Urinary Dysfunction Measurement Scale) 1 MSHQ (Male Sexual Health Questionnaire) 1 PGI-S (Patient Global Impression of Severity) 1 QS-F (Sexual Quotient–Female Version) 1 SUI number of daily pads 1 Impact on quality of life P-QoL (Prolapse Quality of Life) 10 PFIQ-7 (Pelvic Floor Impact Questionnaire–Short Form) 8 IIQ-7 (Incontinence Impact Questionnaire–Short Form) 6 ICIQ-UI SF (International Consultation on Incontinence Questionnaire–Urinary Symptoms) 4 ICIQ-VS (International Consultation on Incontinence Questionnaire–Vaginal Symptoms) 3 KHQ (King’s Health Questionnaire) 3 UIQ-7 (Urogenital Impact Questionnaire) 3 DDI (Defecatory Distress Inventory) 2 EQ5D [Quality of Life (EuroQol)] 2 POPIQ-7 (Pelvic Floor Impact Questionnaire–Prolapse) 2 VAS (0–10) 2 CRAIQ-7 (Colorectal–Anal Impact Questionnaire) 1 PSI-QOL (Prolapse Symptom Inventory and Quality of Life Questionnaire) 1 SF-12 (12-Item Short-Form Health Survey) 1 SF-36 (36-Item Short-Form Health Survey) 1 Satisfaction Patient satisfaction with treatment, VAS (0–10) 3 Patient satisfaction with treatment, PGI (Patient Global Improvement) 3 Patient satisfaction with treatment (yes/no) 3 Patient satisfaction with treatment, VAS (0–100) 2 Patient satisfaction with treatment, VAS (0–4) 1 Patient satisfaction with treatment, custom (0–5) 1 Patient acceptability of preoperative bowel preparation, VAS) (0–4) 1 Surgeon satisfaction with preoperative bowel preparation, Likert scale (0–4) 1 Surgeon ease to perform operation, Likert scale (0–4) 1 Surgeon’s satisfaction with operation, VAS (0–100) 1 Cost/effectiveness Incremental cost per quality-adjusted life-year (QALY) 2 Cost of procedure (US$) 1 TVUSS transvaginal ultrasound scan, HVS high vaginal swab, FBC full blood count Table 5 Reported outcomes by by more than eight studies with greater than 93 participants (median value) Study Sample size ( N ) Outcomes Anatomical prolapse stage Quality of life and impact from symptoms Complications intra-/postoperatively Sexual dysfunction symptoms Postoperative hospital stay length Urinary symptoms Patient satisfaction with treatment Prolapse symptoms postoperatively Postoperative pain Glazener et al. 1352 x x x x x x Altman et al. 389 x x x Wei et al. 337 x x Weemhoff et al. 246 x Nieminen et al. 203 x x Hiltunen et al. 202 x x Farthmann et al. 200 x x x Kamilya et al. 200 x Withagen et al. 194 x x x x x Natale et al. 190 x x Thiagamoorthy et al. 190 x da Silveira et al. 184 x x Borstad et al. 184 x Van et al. 179 x Sand et al. 161 x Rudnicki et al. 160 x x x Gandhi et al. 154 x Ballard et al. 150 x de Tayrac et al. 147 x x x Carey et al. 139 x x x x Rudnicki et al. 138 x Dahlgren et al. 135 x x x x Stekkinger et al. 126 x Vollebregt et al. 125 x x x x Qatawneh et al. 116 x x x x Weber et al. 114 x x Chmielewski et al. 114 x Gupta et al. 106 x x Tamanini et al. 100 x x x x Hakvoort 100 x Menefee et al. 99 x x x x Ek et al. 99 x Guerette et al. 94 x x x x Westermann et al. 93 x x Studies not included <93 19 16 11 5 5 8 4 3 4 Total studies 43 25 23 14 11 11 11 9 8 Outcome measures reported in 80 randomised controlled trials (RCTs) evaluating surgical management of anterior-compartment prolapse TVUSS transvaginal ultrasound scan, HVS high vaginal swab, FBC full blood count Reported outcomes by by more than eight studies with greater than 93 participants (median value) We observed a moderate correlation between outcome reporting quality and year of publication in the univariate analysis ( r 0.458; p  < .001) and study quality ( r 0.409; p  < .001) (Table 6 ). The latter index significantly affected outcome reporting in the multivariate logistic regression (β = 0.412; p  = .018). Table 6 Univariate and multivariate correlation with outcome reporting quality Factor Univariate Multivariate Spearman’s rho P value Beta P value Study quality (Jadad) 00.409 <0.001 0.412 0.018 Journal IF 0.053 0.643 0.078 0.306 Year of publication 0.458 <0.001 0.149 0.295 Study size 0.215 0.051 0.008 0.961 Journal type – – 0.024 0.852 Commercial funding – – −0.013 0.918 Validated questionnaire – – 1.310 0.196 Bolded data statistically significant Univariate and multivariate correlation with outcome reporting quality Bolded data statistically significant

This systematic review is part of a wider project of the International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health (CHORUS) ( i-chorus.org ) and was registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative database, registration number 981, and with the International Prospective Register of Systematic Reviews (PROSPERO), registration identification CRD42017062456. We searched bibliographical databases comprising the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE and MEDLINE from inception to September 2017. The search strategy used several MeSH terms, including bladder prolapse, cystocele and POP. Randomised trials evaluating surgical interventions for anterior-compartment prolapse were eligible. We included trials evaluating the surgical management of anterior prolapse as a unicompartmental prolapse procedure, as well as trials in which anterior repair was undertaken in addition to other surgical interventions. Non-randomised studies, observational studies and case reports were excluded. Two researchers (CD and AE) independently screened the titles and abstracts of electronically retrieved articles. The articles potentially eligible for inclusion were retrieved in full text to assess eligibility, and reference lists were independently reviewed. Any discrepancies between the researchers were resolved by review of a third senior researcher (SKD). Two researchers (CD and AE) independently extracted the study characteristics, including year of publication, journal topicality (subspecialist, general obstetrics and gynaecology or general medicine), journal’s impact factor and commercial funding (yes/no). The journal’s impact factor was determined using InCites Journal Citation Reports (Clarivate Analytics, Thomson Reuters, New York, NY, USA). Funding status was identified by reviewing the article text and included the donation of equipment or other resources. Two researchers (CD and AE) independently assessed the methodological quality of included randomised trials using the modified Jadad criteria (score range 1–5) [ 8 ]. Studies were assessed as high quality when they achieved a score >4. Outcome reporting quality was assessed using the Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria (score range 1–5) [ 9 ]. Studies were assessed as high quality when they achieved a score >4. The non-parametric Spearman’s rank correlation coefficient (Spearman’s rho) was used to explore univariate associations between outcome reporting quality and impact factor during the year of publication, year of publication and methodological quality. Multivariate linear regression analysis using the Enter model was also undertaken to assess the combined association of quality of outcome reporting and journal type, impact factor during the year of publication, year of publication and methodological quality (independent variables) with outcome reporting (dependent variable). All tests were two-tailed. Statistical significance was set at 0.05, and analyses were conducted using the SPSS statistical software (IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA). This study was reported with reference to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [ 6 ].

Anterior-compartment prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues.

This study demonstrated considerable variation in outcome and outcome-measure reporting across published trials evaluating surgical interventions for anterior-compartment prolapse. Commonly reported outcomes included normalised anatomy, QoL and pain. Patient-reported outcomes were infrequently reported, and a minority of trials reported on patient satisfaction. Mesh-related complications, including erosion, shrinkage and morbidity, were rarely reported. Forty-five different questionnaires were used as measurement instruments; most were validated. Only a few trials considered cost effectiveness. Strengths of our systematic review include originality, a rigorous search strategy and methodological robustness. To our knowledge, this systematic review is the first to evaluate outcomes and outcome measures in anterior-compartment prolapse trials. Study screening and selection and data extraction and assessment were conducted independently by two researchers to avoid bias. Our findings were based on outcome reporting in published randomised trials. The exclusion of observational studies may have potentially missed outcomes related to harm [ 89 , 90 ] and selecting only trials reported in English may have introduced selection bias. The variation of interventions for correcting anterior prolapse may have caused variation in outcome and outcome-measure reporting. Randomised trials require a substantial investment of resources. Variation in outcomes and outcome measures limits the ability of trials to be combined with meta-analyses, which contributes to inevitable research waste, as identified in various areas of women’s health, including childbirth trauma, endometriosis and pre-eclampsia [ 91 – 94 ]. This systematic review is the first step in the development of a minimum data set, which will be known as a core outcome set. It will be developed with reference to methods described by the COMET initiative, Core Outcomes in Women’s and Newborn Health (CROWN) initiative and other core-outcome-set development studies, including those on endometriosis, pre-eclampsia, termination of pregnancy, Twin-Twin Transfusion Syndrome and neonatal medicine [ 95 – 99 ]. CHORUS is aiming to work towards a standardisation of outcomes and outcome measures and subsequently establish a minimum of standards in research and clinical practice. Chorus working groups are currently evaluating reported outcomes in all areas of urogyneacology and have been registered with the COMET (registration number 981, http://www.comet-initiative.org/studies/details/981 ) and CROWN initiatives. Each working group has carefully considered the scope of its work [ 100 ], and CHORUS will replicate the success of other international initiatives that have standardised outcome selection, collection and reporting across preterm birth research [ 101 ]. In the absence of a core outcome, we recommend QoL (incorporating sexual function), postoperative complications, patient and physician satisfaction and postoperative prolapse, bladder and bowel symptoms be collected across all anterior prolapse trials.

The most common type of pelvic organ prolapse (PO) is anterior-compartment prolapse. Hendrix et al. demonstrated in a group of 16,616 postmenopausal women a prevalence of anterior-compartment prolapse of 34%, and this was much higher than the rates of apical- or posterior-compartment prolapse [ 1 ]. The aetiology of pelvic organ prolapse (POP) is complex and associated with various factors such as age, menopausal status and childbirth-related pelvic floor trauma [ 2 , 3 ]. Possible surgical interventions include biological-graft, mesh and native tissue repair [ 4 , 5 ]. The development of new surgical interventions is urgently required, and potential surgical interventions require robust evaluation. Selecting appropriate efficacy and safety outcomes is a crucial step in designing randomised trials. Outcomes collected and reported in randomised trials should be relevant to a broad range of stakeholders, including women with anterior-compartment prolapse, healthcare professionals and researchers. For example, resolution of bladder symptoms is an important outcome for all stakeholders; however, it is not commonly reported across trials. Even when outcomes have been consistently reported, secondary research methods, including pair-wise meta-analysis, may be limited by the use of different definitions and measurement instruments [ 6 , 7 ]. A core outcome set should help address these issues. The first stage in core outcome-set development is to evaluate outcome and outcome-measure reporting across published trials. Therefore, we systematically evaluated outcome and outcome-measure reporting in published randomised trials evaluating surgical interventions for anterior-compartment prolapse. In addition, we assessed the relationships between outcome reporting quality with other important variables, including year of publication, impact factor and methodological quality.