Int Urogynecol J DOI 10.1007/s00192-015-2641-9
ORIGINAL ARTICLE
New onset stress urinary incontinence following laparoscopic sacrocolpopexy and its relation to anatomical outcomes Dina El Hamamsy & Abdalla M. Fayyad
Received: 9 September 2014 / Accepted: 26 January 2015 # The International Urogynecological Association 2015
Abstract Introduction and hypothesis The aim of this study was to assess the incidence of stress urinary incontinence (SUI) following laparoscopic sacrocolpopexy in continent women and its relation to postoperative prolapse stage. Methods A total of 220 continent women with symptomatic apical prolapse who underwent laparoscopic sacrocolpopexy were prospectively evaluated; 100 women had previous hysterectomy. Patients were followed up at 3 and 12 months after surgery. All subjects completed the King’s Health Questionnaire (KHQ) and Prolapse Quality of Life Questionnaire (PQOL) and were examined using the Pelvic Organ Prolapse Quantification (POP-Q) system. The primary outcome measure was the number of women who developed new onset moderate/severe SUI at 3 and 12 months postoperatively and its relation to postoperative prolapse stage. Results At 3 months, 52 women (23.6 %) developed moderate/severe SUI; 27 (12.2 %) had severe SUI. Eleven women (5.0 %) underwent surgery for SUI within 6 months of sacrocolpopexy. All surgery for SUI was in women who had post-hysterectomy sacrocolpopexy. Postoperatively, the vaginal apex (point C) was at stage 0/I in 195 cases (88.6 %). There were no differences in postoperative POP-Q stage of the anterior and apical vaginal walls between continent women and those with SUI (p=0.45). The posterior vaginal wall was higher in women who developed de novo SUI (p=0.03). Conclusions The incidence of SUI following apical prolapse repair is 23.6 %. Subsequent continence procedures were performed in 5.0 % of patients. All were in women who had previous hysterectomy making the risk in this group 11 %.
Higher POP-Q stage of the posterior vaginal wall was associated with SUI.
D. El Hamamsy : A. M. Fayyad (*) Urogynaecology Unit, Luton and Dunstable University Hospital, Luton, UK e-mail: [email protected]
Materials and methods
Keywords Laparoscopic sacrocolpopexy . TVT . Vaginal prolapse . Stress urinary incontinence
Introduction There is currently no consensus on the routine use of incontinence procedures in women undergoing surgery for apical vaginal prolapse with no or little stress urinary incontinence (SUI) preoperatively. Practices in prolapse surgery vary around the world from performing routine SUI surgery in women with prolapse repair regardless of continence status to a view that concomitant incontinence surgery should not be performed even in women with SUI [1]. The widely quoted Colpopexy and Urinary Reduction (CARE) trial shows benefit in routinely performing colposuspension at the time of sacrocolpopexy [2]. In the CARE trial, the rate of SUI in women who did not have colposuspension at the time of sacrocolpopexy was 45 % at 2 years. More recently, studies showed lack of benefit from a routine additional incontinence procedure at the time of sacrocolpopexy [3], with the added risks of voiding dysfunction and posterior vaginal wall prolapse [1]. The aim of this study was to assess the incidence of new onset SUI following sacrocolpopexy in continent women and its relation to postoperative prolapse stage and patient global impression of improvement.
A total of 220 consecutive continent patients who presented with vaginal prolapse between February 2010 and August
Int Urogynecol J
2012, and were found to have apical prolapse, defined as stage II or more on the Pelvic Organ Prolapse Quantification (POPQ) system [4], were prospectively recruited to the study. The study had the approval of the Institutional Review Board (IRB). Upon initial presentation, patients completed the King’s Health Questionnaire (KHQ) [5] and Prolapse Quality of Life Questionnaire (P-QOL) [6] and were examined using the POP-Q system [4]. None of the patients underwent urodynamic studies preoperatively. Post-hysterectomy laparoscopic sacrocolpopexy was performed with patients in semi-lithotomy position. After skin preparation, and draping, a pneumoperitoneum was created and three laparoscopic ports were placed, 11-mm umbilical and left lateral ports and 5-mm right lateral port. The lateral ports were placed 1 cm below the level of the umbilicus under direct vision. The rectovaginal fascia was opened using monopolar diathermy scissors with dissection to the level of the perineal body and rectovaginal reflection. The bladder was then dissected from the anterior vaginal wall laparoscopically over a vaginal probe. Dissection was carried out to the level of the trigone. The sacral promontory was subsequently visualized and the presacral peritoneum opened with monopolar diathermy and laparoscopic scissors and dissected all the way down to the right side of the rectosigmoid. A polypropylene mesh was sutured to the vaginal walls including the posterior, anterior and vaginal vault using 20cm mesh, which is used as two sheets folded in the middle (Ushaped mesh). The folded end of the mesh was then tacked to the sacral promontory with 5-mm helical fasteners (Protack, United States Surgical, Tyco Healthcare, Norwalk, CT, USA). Finally, the mesh was completely covered with peritoneum, gas was expelled and ports withdrawn under vision. The urinary catheter was removed the following morning. If the patient had an intact uterus, the procedure was started vaginally with either anterior and/or posterior vaginal wall repair if there was preoperative evidence of anatomical level 2 defect. The repair was performed following initial hydrodissection and vertical vaginal incision through skin and fascia. Lateral dissection was performed and two polydioxanone (PDS, Ethicon Inc., Somerville, NJ, USA) sutures were placed in the fascia, with the most cranial suture attached to the body of the cervix cranial to the level of the mesh. The vaginal skin and fascia were closed en mass in a continuous locking fashion. A uterine manipulator was then inserted after uterine sounding and the procedure was then completed laparoscopically with the woman in semilithotomy position. After skin preparation, and draping, a pneumoperitoneum was created and three laparoscopic ports were placed, 11-mm umbilical and left lateral ports and 5-mm right lateral port. The lateral ports were placed 1 cm below the level of the umbilicus under direct vision. The sacral promontory was subsequently
visualized and the presacral peritoneum opened with monopolar diathermy and laparoscopic scissors and dissected all the way down to the level of the cervix on the right side of the rectosigmoid. Polypropylene mesh was then sutured to the back of the cervix with four permanent sutures. The tail end of the mesh was then retrieved and the uterus pushed up to the maximum using the uterine manipulator. The mesh was then tacked to the sacral promontory with 5-mm helical fasteners (Protack, United States Surgical, Tyco Healthcare, Norwalk, CT, USA). Finally, the mesh was completely covered with peritoneum. The total length of the mesh used in women with intact uterus was 10–15 cm and 20–30 cm in women who had previous hysterectomy. The mesh in the latter group was used as two sheets, with each sheet supporting the anterior and the posterior vaginal walls to the sacral promontory. Hence, the length of the mesh extending between the pelvis and the promontory was the same in both groups (i.e. 10 cm). Patients were followed up at 3 and 12 months postoperatively, where they completed the KHQ and P-QOL as well as the Patient Global Impression of Improvement (PGI-I) [7]. Patients were also examined using the POP-Q system. Women who reported moderate/severe postoperative SUI were examined using the cough stress test and underwent urodynamic investigation including multichannel cystometry. The primary outcome measure was the number of patients developing new onset moderate/severe SUI on the KHQ postoperatively and its relation to postoperative prolapse stage. The secondary outcome measure was the relation between patient global impression of improvement and postoperative incontinence status. Statistical analysis was performed with SPSS 10 using the paired sample t test for continuous variables and Fisher’s exact test for categorical variables.
Results The mean age of the patients was 64 and the mean body mass index (BMI) was 27 kg/m2. Of the patients, 82 % were postmenopausal, 120 women had intact uterus and underwent laparoscopic sacrocolpohysteropexy and 100 were post hysterectomy and underwent laparoscopic sacrocolpopexy. Table 1 shows the patient demographics. Of the women in the posthysterectomy sacrocolpopexy group, 62 (62 %) had previous prolapse repair and 18 (15 %) in the intact uterus group had previous prolapse repair. At 3 months, 52 patients (23.6 %) reported moderate or severe SUI as a new symptom; 27 (12.2 %) had severe and 25 (11.4 %) had moderate SUI. Eleven patients (5.0 %) underwent a subsequent incontinence procedure for SUI. Ten patients underwent the retropubic tension-free vaginal free tape (TVT) procedure [8] and one patient underwent treatment with a urethral bulking agent. All incontinence
Int Urogynecol J Table 1
Patient demographics
Table 3
Postoperative POP-Q measurements between the two groups
n=220
Mean (range)
POP-Q
No/little SUI n=168
Moderate/severe SUI n=52
p value
Age (years) Parity Menopausal BMI (kg/m2) Previous hysterectomy Stage IV
64 (24–84) 2 (0–5) n=180 (81.8 %) 29 (22–40) n=120 (54.5 %) n=27 (38.6 %)
Aa Ba C Ap
−2 (−3 to 0) −2 (−3 to +1) −7.5 (−9 to −4) −2 (−2 to +1)
−2 (−3 to 0) −2.5 (−3 to +0.5) −8 (−9 to −6) −3 (−3 to +1)
0.7 0.8 0.75 0.03
Bp
−2 (−3 to +1)
−3 (−3 to 0)
0.02
procedures were performed within the first 6 months after the initial prolapse surgery (Table 2). At 12 months, among the remaining 209 patients who did not undergo an incontinence procedure, 27 women (12.9 %) had moderate SUI, and all opted for conservative treatment by pelvic floor physiotherapy. All women who underwent a surgical procedure for incontinence were in the group that had post-hysterectomy vaginal vault prolapse, rather than women with intact uterus, making the incidence of incontinence surgery in this group of women (i.e. post-hysterectomy sacrocolpopexy) 11 %. On examination, there were no differences in postoperative point Ba [−2 (−3 to +1) vs −2.5 (−3 to +0.5), p=0.8] and C [−7.5 (−9 to −4) vs −8 (−9 to −6), p=0.75] between the groups that developed moderate/severe SUI and no/mild SUI. Point Bp, however, was statistically higher in women with SUI compared to the no/mild SUI [−3 (−3 to −1) vs −2 (−2 to + 1), p=0.03] (Table 3). Postoperative PGI-I showed that 182 women (77.7 %) reported feeling either Bmuch better^ or Bvery much better^ at 3 months (Table 4). Fisher’s exact test showed no difference in PGI-I between women who developed moderate/severe SUI and those who did not (p=0.261, risk ratio=2.64, 95 % confidence interval 0.54–13.04). This could not be assessed at 12 months as 11 women with severe SUI underwent an incontinence procedure by 12 months. Two women in the post-hysterectomy sacrocolpopexy group developed mesh extrusion into the vagina, which was excised vaginally. There were no cases of mesh extrusion into the vagina in the sacrocolpopexy group with intact uterus.
Table 2 SUI
Severe Moderate Mild Nil a
SUI at 3 and 12 months postoperatively 3 months n=220
12 months n=209a
27 (12.2 %) 25 (11.4 %) 25 (11.4 %) 143 (65.0 %)
0 15 (7.2 %) 21 (10 %) 173 (82.8 %)
Eleven patients underwent an incontinence procedure for SUI
Discussion This study supports the findings of previously published literature on the incidence of new onset SUI following sacrocolpopexy in continent women [9, 10]. Debate continues over the incidence of new onset SUI following vaginal prolapse repair [1–3, 11] and whether routine incontinence surgery should be performed at the time of prolapse repair. The widely quoted CARE trial showed that the incidence of SUI following sacrocolpopexy without Burch colposuspension was 44.1 % [2]. The criteria used to define postoperative urinary incontinence in the CARE trial were any of the following: first, Byes^ answer to questions about SUI with coughing, sneezing or laughing, physical exercise, lifting or bending over; second, a positive stress cough test with full bladder or the bladder filled at 300 ml; and third, any treatment of SUI following the prolapse surgery. The above outcome criteria explain the high incidence of SUI in women who did not receive colposuspension. In the CARE trial, the incidence of bothersome SUI following sacrocolpopexy without concomitant Burch colposuspension was 24.5 % based on answers about degree of bother in the Pelvic Floor Distress Inventory (PFDI) questionnaire [12]. In this study we showed that the incidence of moderate and severe SUI following sacrocolpopexy was 23.6 %. The degree of stress incontinence was bothersome enough to warrant further incontinence surgery in only 5 % of women. At 12 months, none of the women had severe SUI and 12 %
Table 4 PGI-I at 3 months between the group who developed moderate/severe SUI and no/little SUI group PGI-I
No/little SUI n=168
Moderate/severe SUI n=52
Very much better Much better Little better Same/worse
n=62 (36.9 %) n=78 (46.4 %) n=19 (11.3 %) n=9 (5.3 %)
n=18 (34.6 %) n=23 (44.2 %) n=5 (9.6 %) n=6 (11.5 %)
There were no differences in PGI-I between the two groups at 3 months: p=0.261, risk ratio=2.64, 95 % confidence interval 0.54–13.04 (Fisher’s exact test)
Int Urogynecol J
had moderate SUI. This indicates a potential for natural improvement of SUI up to 12 months following sacrocolpopexy, even after taking into consideration that 5 % of women already had an incontinence procedure, as 16 women reported severe SUI at 3 months and opted to avoid incontinence surgery. These findings support the study by Maher et al. on the incidence of new onset SUI following abdominal sacrocolpopexy which was reported at 9 % [9]. Performing B u r c h c o l p os u s p en s i o n r o u t i ne l y a t th e t i m e o f sacrocolpopexy needs to be balanced against potential complications including postoperative voiding dysfunction and posterior vaginal wall prolapse [1, 13]. Increasingly, midurethral slings [8] have become the standard treatment of women with SUI, replacing the Burch colposuspension over the last 10 years [1]. These procedures, however, are not without complications. Analysis of complications of TVT from the Netherlands Tension-Free Vaginal Tape study showed an overall complication rate of 20.9 %. Retropubic haematoma developed in 3.4 %, bladder injury in 3.5 %, mesh extrusion in 0.2 % and indwelling catheter drainage needed in 14.9 % and TVT division rate for voiding dysfunction (1.6 %) [14]. In a prospective randomized controlled trial of the routine use of TVT at the time of prolapse repair in women with occult SUI, Schierlitz et al. showed that ten TVT slings have to be inserted at the time of prolapse surgery in women with occult SUI to prevent one TVT sling being inserted 2–4 years following surgery [10]. In the OPUS trial, which is a randomized controlled trial designed to assess the value of concomitant TVT in continent women with anterior vaginal wall prolapse, it was found that at 12 months 27 % of women who had TVT still suffered from SUI, compared to 43 % in women with no TVT. This study showed that six TVT have to be inserted at the time of prolapse repair to prevent one sling insertion postoperatively [15]. In this study we showed that the anatomical outcome of anterior and apical vaginal prolapse has no relation to the development of SUI. This suggests that the incidence of bothersome SUI postoperatively in our study was not related to anatomical recurrence of apical or anterior vaginal wall prolapse. This study, however, showed that SUI was related to higher support of the posterior vaginal wall. This relation needs further evaluation in future prospective studies. This can be partially explained by the support of the urethra from descent of the posterior vaginal wall, which may mask SUI. Similar findings between posterior vaginal wall support and development of SUI were reported by Maher et al. [9]. In this study, 33 % of women having vaginal sacrospinous fixation developed SUI. The authors attributed this to the vagina being supported under increased tension in a posterior direction following vaginal sacrospinous fixation. In this study we showed that sacrocolpopexy for posthysterectomy vaginal vault prolapse was more likely to result in bothersome SUI needing incontinence surgery compared to
surgery performed in women with intact uterus. We postulate that post-hysterectomy sacrocolpopexy is a risk factor for new onset SUI compared to sacrocolpopexy with intact uterus due to the technique of the operation. Following hysterectomy, the surgery was performed with the use of mesh that extends to the rectovaginal reflection posteriorly and the junction of the vagina and the bladder at the level of the trigone anteriorly. This technique is not employed in women with intact uterus as the mesh is fixed to the back of the uterus. Hence, the technique in women following hysterectomy can result in straightening of the urethrovesical junction. This does not seem to happen in women with intact uterus. In this study we showed that the development of SUI did not affect the patient’s global impression of improvement following prolapse repair. To our knowledge this has not been reported before and needs further evaluation in prospective studies of prolapse surgery. The strengths of this study include its prospective nature and the longer follow-up of patients up to 12 months following surgery. Our study cohort was a pure group of patients having laparoscopic sacrocolpopexy for apical prolapse, compared to other studies where SUI was assessed in relation to all vaginal prolapse repairs [10, 15]. To our knowledge, the development of SUI following laparoscopic sacrocolpopexy in continent women was not reported before. In addition, the study reported the anatomical outcomes of prolapse using POP-Q and their relation to the development of SUI. The weaknesses of this study include the reporting of SUI following laparoscopic sacrocolpopexy. Hence, the findings cannot be generalized to other forms of apical prolapse surgery including robotic or open sacrocolpopexy and other forms of vaginal prolapse surgery. In addition, the study included women with intact uterus and those following hysterectomy who suffer from apical prolapse. Our study suggests that they may be two distinct groups in this regard and further studies of the two groups are needed. Our findings do not support routinely performing an incontinence procedure at the time of sacrocolpopexy, as such practice will result in large numbers of such procedures being performed unnecessarily, with significant risk and cost implications [1].
Conclusions The incidence of new onset moderate/severe SUI following sacrocolpopexy was 23.6 %. A subsequent continence procedure was performed in 5 % of patients. This was not related to postoperative anterior compartment or apical prolapse and did not affect patient satisfaction. The role of posterior vaginal wall support in developing postoperative SUI needs further evaluation.
Int Urogynecol J Conflicts of interest None.
References 1. Dwyer PL (2012) Women with occult stress incontinence should not routinely have a mid-urethral sling with prolapse surgery. Int Urogynecol J 23:827–829. doi:10.1007/s00192012-1690-6 2. Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM, Pelvic Floor Disorders Network (2006) Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 354(15):1557–1566 3. Costantini E, Lazzeri M, Bini V, Del Zingaro M, Zucchi A, Porena M (2011) Pelvic organ prolapse repair with and without prophylactic concomitant Burch colposuspension in continent women: a randomized, controlled trial with 8-year followup. J Urol 185(6):2236–2240 4. Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P et al (1996) The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 175:10–17 5. Kelleher CJ, Cardozo LD, Khullar V, Salvatore S (1997) A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 104(12):1374–1379 6. Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S (2005) P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct 16:176–181
7. Sirikrishna S, Robinson D, Cardozo D (2010) Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J 21:523–528 8. Ulmsten U, Falconer C, Johnson P et al (1998) A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 9(4):210– 213 9. Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, Schluter P (2004) Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol 190:20–26 10. Schierlitz L, Dwyer PL, Rosamilia A et al (2010) A prospective randomized controlled study comparing vaginal prolapse repair with and without Tension free Vaginal Tape (TVT) in women with severe genital prolapse and occult stress incontinence. 3 year follow up. Int Urogynecol J 21(Suppl 1):S2 11. Malak M (2012) The role of anti-incontinence surgery in management of occult urinary stress incontinence. Int Urogynecol J 23:823– 825 12. Barber MD, Kuchibhatla MN, Pieper CF, Bump RC (2001) Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol 185:1388–1395 13. Wiskind AK, Creighton SM, Stanton SL (1992) The incidence of genital prolapse after the Burch colposuspension. Am J Obstet Gynecol 167(2):399–404 14. Schraffordt Koops S, Bisseling TM, Heintz PM et al (2005) Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study. Am J Obstet Gynecol 193:45–52 15. Wei J (2011) A midurethral sling prevents incontinence among women undergoing vaginal prolapse repair-the OPUS trial. Neurourol Urodyn 30:809–811
ORIGINAL ARTICLE
New onset stress urinary incontinence following laparoscopic sacrocolpopexy and its relation to anatomical outcomes Dina El Hamamsy & Abdalla M. Fayyad
Received: 9 September 2014 / Accepted: 26 January 2015 # The International Urogynecological Association 2015
Abstract Introduction and hypothesis The aim of this study was to assess the incidence of stress urinary incontinence (SUI) following laparoscopic sacrocolpopexy in continent women and its relation to postoperative prolapse stage. Methods A total of 220 continent women with symptomatic apical prolapse who underwent laparoscopic sacrocolpopexy were prospectively evaluated; 100 women had previous hysterectomy. Patients were followed up at 3 and 12 months after surgery. All subjects completed the King’s Health Questionnaire (KHQ) and Prolapse Quality of Life Questionnaire (PQOL) and were examined using the Pelvic Organ Prolapse Quantification (POP-Q) system. The primary outcome measure was the number of women who developed new onset moderate/severe SUI at 3 and 12 months postoperatively and its relation to postoperative prolapse stage. Results At 3 months, 52 women (23.6 %) developed moderate/severe SUI; 27 (12.2 %) had severe SUI. Eleven women (5.0 %) underwent surgery for SUI within 6 months of sacrocolpopexy. All surgery for SUI was in women who had post-hysterectomy sacrocolpopexy. Postoperatively, the vaginal apex (point C) was at stage 0/I in 195 cases (88.6 %). There were no differences in postoperative POP-Q stage of the anterior and apical vaginal walls between continent women and those with SUI (p=0.45). The posterior vaginal wall was higher in women who developed de novo SUI (p=0.03). Conclusions The incidence of SUI following apical prolapse repair is 23.6 %. Subsequent continence procedures were performed in 5.0 % of patients. All were in women who had previous hysterectomy making the risk in this group 11 %.
Higher POP-Q stage of the posterior vaginal wall was associated with SUI.
D. El Hamamsy : A. M. Fayyad (*) Urogynaecology Unit, Luton and Dunstable University Hospital, Luton, UK e-mail: [email protected]
Materials and methods
Keywords Laparoscopic sacrocolpopexy . TVT . Vaginal prolapse . Stress urinary incontinence
Introduction There is currently no consensus on the routine use of incontinence procedures in women undergoing surgery for apical vaginal prolapse with no or little stress urinary incontinence (SUI) preoperatively. Practices in prolapse surgery vary around the world from performing routine SUI surgery in women with prolapse repair regardless of continence status to a view that concomitant incontinence surgery should not be performed even in women with SUI [1]. The widely quoted Colpopexy and Urinary Reduction (CARE) trial shows benefit in routinely performing colposuspension at the time of sacrocolpopexy [2]. In the CARE trial, the rate of SUI in women who did not have colposuspension at the time of sacrocolpopexy was 45 % at 2 years. More recently, studies showed lack of benefit from a routine additional incontinence procedure at the time of sacrocolpopexy [3], with the added risks of voiding dysfunction and posterior vaginal wall prolapse [1]. The aim of this study was to assess the incidence of new onset SUI following sacrocolpopexy in continent women and its relation to postoperative prolapse stage and patient global impression of improvement.
A total of 220 consecutive continent patients who presented with vaginal prolapse between February 2010 and August
Int Urogynecol J
2012, and were found to have apical prolapse, defined as stage II or more on the Pelvic Organ Prolapse Quantification (POPQ) system [4], were prospectively recruited to the study. The study had the approval of the Institutional Review Board (IRB). Upon initial presentation, patients completed the King’s Health Questionnaire (KHQ) [5] and Prolapse Quality of Life Questionnaire (P-QOL) [6] and were examined using the POP-Q system [4]. None of the patients underwent urodynamic studies preoperatively. Post-hysterectomy laparoscopic sacrocolpopexy was performed with patients in semi-lithotomy position. After skin preparation, and draping, a pneumoperitoneum was created and three laparoscopic ports were placed, 11-mm umbilical and left lateral ports and 5-mm right lateral port. The lateral ports were placed 1 cm below the level of the umbilicus under direct vision. The rectovaginal fascia was opened using monopolar diathermy scissors with dissection to the level of the perineal body and rectovaginal reflection. The bladder was then dissected from the anterior vaginal wall laparoscopically over a vaginal probe. Dissection was carried out to the level of the trigone. The sacral promontory was subsequently visualized and the presacral peritoneum opened with monopolar diathermy and laparoscopic scissors and dissected all the way down to the right side of the rectosigmoid. A polypropylene mesh was sutured to the vaginal walls including the posterior, anterior and vaginal vault using 20cm mesh, which is used as two sheets folded in the middle (Ushaped mesh). The folded end of the mesh was then tacked to the sacral promontory with 5-mm helical fasteners (Protack, United States Surgical, Tyco Healthcare, Norwalk, CT, USA). Finally, the mesh was completely covered with peritoneum, gas was expelled and ports withdrawn under vision. The urinary catheter was removed the following morning. If the patient had an intact uterus, the procedure was started vaginally with either anterior and/or posterior vaginal wall repair if there was preoperative evidence of anatomical level 2 defect. The repair was performed following initial hydrodissection and vertical vaginal incision through skin and fascia. Lateral dissection was performed and two polydioxanone (PDS, Ethicon Inc., Somerville, NJ, USA) sutures were placed in the fascia, with the most cranial suture attached to the body of the cervix cranial to the level of the mesh. The vaginal skin and fascia were closed en mass in a continuous locking fashion. A uterine manipulator was then inserted after uterine sounding and the procedure was then completed laparoscopically with the woman in semilithotomy position. After skin preparation, and draping, a pneumoperitoneum was created and three laparoscopic ports were placed, 11-mm umbilical and left lateral ports and 5-mm right lateral port. The lateral ports were placed 1 cm below the level of the umbilicus under direct vision. The sacral promontory was subsequently
visualized and the presacral peritoneum opened with monopolar diathermy and laparoscopic scissors and dissected all the way down to the level of the cervix on the right side of the rectosigmoid. Polypropylene mesh was then sutured to the back of the cervix with four permanent sutures. The tail end of the mesh was then retrieved and the uterus pushed up to the maximum using the uterine manipulator. The mesh was then tacked to the sacral promontory with 5-mm helical fasteners (Protack, United States Surgical, Tyco Healthcare, Norwalk, CT, USA). Finally, the mesh was completely covered with peritoneum. The total length of the mesh used in women with intact uterus was 10–15 cm and 20–30 cm in women who had previous hysterectomy. The mesh in the latter group was used as two sheets, with each sheet supporting the anterior and the posterior vaginal walls to the sacral promontory. Hence, the length of the mesh extending between the pelvis and the promontory was the same in both groups (i.e. 10 cm). Patients were followed up at 3 and 12 months postoperatively, where they completed the KHQ and P-QOL as well as the Patient Global Impression of Improvement (PGI-I) [7]. Patients were also examined using the POP-Q system. Women who reported moderate/severe postoperative SUI were examined using the cough stress test and underwent urodynamic investigation including multichannel cystometry. The primary outcome measure was the number of patients developing new onset moderate/severe SUI on the KHQ postoperatively and its relation to postoperative prolapse stage. The secondary outcome measure was the relation between patient global impression of improvement and postoperative incontinence status. Statistical analysis was performed with SPSS 10 using the paired sample t test for continuous variables and Fisher’s exact test for categorical variables.
Results The mean age of the patients was 64 and the mean body mass index (BMI) was 27 kg/m2. Of the patients, 82 % were postmenopausal, 120 women had intact uterus and underwent laparoscopic sacrocolpohysteropexy and 100 were post hysterectomy and underwent laparoscopic sacrocolpopexy. Table 1 shows the patient demographics. Of the women in the posthysterectomy sacrocolpopexy group, 62 (62 %) had previous prolapse repair and 18 (15 %) in the intact uterus group had previous prolapse repair. At 3 months, 52 patients (23.6 %) reported moderate or severe SUI as a new symptom; 27 (12.2 %) had severe and 25 (11.4 %) had moderate SUI. Eleven patients (5.0 %) underwent a subsequent incontinence procedure for SUI. Ten patients underwent the retropubic tension-free vaginal free tape (TVT) procedure [8] and one patient underwent treatment with a urethral bulking agent. All incontinence
Int Urogynecol J Table 1
Patient demographics
Table 3
Postoperative POP-Q measurements between the two groups
n=220
Mean (range)
POP-Q
No/little SUI n=168
Moderate/severe SUI n=52
p value
Age (years) Parity Menopausal BMI (kg/m2) Previous hysterectomy Stage IV
64 (24–84) 2 (0–5) n=180 (81.8 %) 29 (22–40) n=120 (54.5 %) n=27 (38.6 %)
Aa Ba C Ap
−2 (−3 to 0) −2 (−3 to +1) −7.5 (−9 to −4) −2 (−2 to +1)
−2 (−3 to 0) −2.5 (−3 to +0.5) −8 (−9 to −6) −3 (−3 to +1)
0.7 0.8 0.75 0.03
Bp
−2 (−3 to +1)
−3 (−3 to 0)
0.02
procedures were performed within the first 6 months after the initial prolapse surgery (Table 2). At 12 months, among the remaining 209 patients who did not undergo an incontinence procedure, 27 women (12.9 %) had moderate SUI, and all opted for conservative treatment by pelvic floor physiotherapy. All women who underwent a surgical procedure for incontinence were in the group that had post-hysterectomy vaginal vault prolapse, rather than women with intact uterus, making the incidence of incontinence surgery in this group of women (i.e. post-hysterectomy sacrocolpopexy) 11 %. On examination, there were no differences in postoperative point Ba [−2 (−3 to +1) vs −2.5 (−3 to +0.5), p=0.8] and C [−7.5 (−9 to −4) vs −8 (−9 to −6), p=0.75] between the groups that developed moderate/severe SUI and no/mild SUI. Point Bp, however, was statistically higher in women with SUI compared to the no/mild SUI [−3 (−3 to −1) vs −2 (−2 to + 1), p=0.03] (Table 3). Postoperative PGI-I showed that 182 women (77.7 %) reported feeling either Bmuch better^ or Bvery much better^ at 3 months (Table 4). Fisher’s exact test showed no difference in PGI-I between women who developed moderate/severe SUI and those who did not (p=0.261, risk ratio=2.64, 95 % confidence interval 0.54–13.04). This could not be assessed at 12 months as 11 women with severe SUI underwent an incontinence procedure by 12 months. Two women in the post-hysterectomy sacrocolpopexy group developed mesh extrusion into the vagina, which was excised vaginally. There were no cases of mesh extrusion into the vagina in the sacrocolpopexy group with intact uterus.
Table 2 SUI
Severe Moderate Mild Nil a
SUI at 3 and 12 months postoperatively 3 months n=220
12 months n=209a
27 (12.2 %) 25 (11.4 %) 25 (11.4 %) 143 (65.0 %)
0 15 (7.2 %) 21 (10 %) 173 (82.8 %)
Eleven patients underwent an incontinence procedure for SUI
Discussion This study supports the findings of previously published literature on the incidence of new onset SUI following sacrocolpopexy in continent women [9, 10]. Debate continues over the incidence of new onset SUI following vaginal prolapse repair [1–3, 11] and whether routine incontinence surgery should be performed at the time of prolapse repair. The widely quoted CARE trial showed that the incidence of SUI following sacrocolpopexy without Burch colposuspension was 44.1 % [2]. The criteria used to define postoperative urinary incontinence in the CARE trial were any of the following: first, Byes^ answer to questions about SUI with coughing, sneezing or laughing, physical exercise, lifting or bending over; second, a positive stress cough test with full bladder or the bladder filled at 300 ml; and third, any treatment of SUI following the prolapse surgery. The above outcome criteria explain the high incidence of SUI in women who did not receive colposuspension. In the CARE trial, the incidence of bothersome SUI following sacrocolpopexy without concomitant Burch colposuspension was 24.5 % based on answers about degree of bother in the Pelvic Floor Distress Inventory (PFDI) questionnaire [12]. In this study we showed that the incidence of moderate and severe SUI following sacrocolpopexy was 23.6 %. The degree of stress incontinence was bothersome enough to warrant further incontinence surgery in only 5 % of women. At 12 months, none of the women had severe SUI and 12 %
Table 4 PGI-I at 3 months between the group who developed moderate/severe SUI and no/little SUI group PGI-I
No/little SUI n=168
Moderate/severe SUI n=52
Very much better Much better Little better Same/worse
n=62 (36.9 %) n=78 (46.4 %) n=19 (11.3 %) n=9 (5.3 %)
n=18 (34.6 %) n=23 (44.2 %) n=5 (9.6 %) n=6 (11.5 %)
There were no differences in PGI-I between the two groups at 3 months: p=0.261, risk ratio=2.64, 95 % confidence interval 0.54–13.04 (Fisher’s exact test)
Int Urogynecol J
had moderate SUI. This indicates a potential for natural improvement of SUI up to 12 months following sacrocolpopexy, even after taking into consideration that 5 % of women already had an incontinence procedure, as 16 women reported severe SUI at 3 months and opted to avoid incontinence surgery. These findings support the study by Maher et al. on the incidence of new onset SUI following abdominal sacrocolpopexy which was reported at 9 % [9]. Performing B u r c h c o l p os u s p en s i o n r o u t i ne l y a t th e t i m e o f sacrocolpopexy needs to be balanced against potential complications including postoperative voiding dysfunction and posterior vaginal wall prolapse [1, 13]. Increasingly, midurethral slings [8] have become the standard treatment of women with SUI, replacing the Burch colposuspension over the last 10 years [1]. These procedures, however, are not without complications. Analysis of complications of TVT from the Netherlands Tension-Free Vaginal Tape study showed an overall complication rate of 20.9 %. Retropubic haematoma developed in 3.4 %, bladder injury in 3.5 %, mesh extrusion in 0.2 % and indwelling catheter drainage needed in 14.9 % and TVT division rate for voiding dysfunction (1.6 %) [14]. In a prospective randomized controlled trial of the routine use of TVT at the time of prolapse repair in women with occult SUI, Schierlitz et al. showed that ten TVT slings have to be inserted at the time of prolapse surgery in women with occult SUI to prevent one TVT sling being inserted 2–4 years following surgery [10]. In the OPUS trial, which is a randomized controlled trial designed to assess the value of concomitant TVT in continent women with anterior vaginal wall prolapse, it was found that at 12 months 27 % of women who had TVT still suffered from SUI, compared to 43 % in women with no TVT. This study showed that six TVT have to be inserted at the time of prolapse repair to prevent one sling insertion postoperatively [15]. In this study we showed that the anatomical outcome of anterior and apical vaginal prolapse has no relation to the development of SUI. This suggests that the incidence of bothersome SUI postoperatively in our study was not related to anatomical recurrence of apical or anterior vaginal wall prolapse. This study, however, showed that SUI was related to higher support of the posterior vaginal wall. This relation needs further evaluation in future prospective studies. This can be partially explained by the support of the urethra from descent of the posterior vaginal wall, which may mask SUI. Similar findings between posterior vaginal wall support and development of SUI were reported by Maher et al. [9]. In this study, 33 % of women having vaginal sacrospinous fixation developed SUI. The authors attributed this to the vagina being supported under increased tension in a posterior direction following vaginal sacrospinous fixation. In this study we showed that sacrocolpopexy for posthysterectomy vaginal vault prolapse was more likely to result in bothersome SUI needing incontinence surgery compared to
surgery performed in women with intact uterus. We postulate that post-hysterectomy sacrocolpopexy is a risk factor for new onset SUI compared to sacrocolpopexy with intact uterus due to the technique of the operation. Following hysterectomy, the surgery was performed with the use of mesh that extends to the rectovaginal reflection posteriorly and the junction of the vagina and the bladder at the level of the trigone anteriorly. This technique is not employed in women with intact uterus as the mesh is fixed to the back of the uterus. Hence, the technique in women following hysterectomy can result in straightening of the urethrovesical junction. This does not seem to happen in women with intact uterus. In this study we showed that the development of SUI did not affect the patient’s global impression of improvement following prolapse repair. To our knowledge this has not been reported before and needs further evaluation in prospective studies of prolapse surgery. The strengths of this study include its prospective nature and the longer follow-up of patients up to 12 months following surgery. Our study cohort was a pure group of patients having laparoscopic sacrocolpopexy for apical prolapse, compared to other studies where SUI was assessed in relation to all vaginal prolapse repairs [10, 15]. To our knowledge, the development of SUI following laparoscopic sacrocolpopexy in continent women was not reported before. In addition, the study reported the anatomical outcomes of prolapse using POP-Q and their relation to the development of SUI. The weaknesses of this study include the reporting of SUI following laparoscopic sacrocolpopexy. Hence, the findings cannot be generalized to other forms of apical prolapse surgery including robotic or open sacrocolpopexy and other forms of vaginal prolapse surgery. In addition, the study included women with intact uterus and those following hysterectomy who suffer from apical prolapse. Our study suggests that they may be two distinct groups in this regard and further studies of the two groups are needed. Our findings do not support routinely performing an incontinence procedure at the time of sacrocolpopexy, as such practice will result in large numbers of such procedures being performed unnecessarily, with significant risk and cost implications [1].
Conclusions The incidence of new onset moderate/severe SUI following sacrocolpopexy was 23.6 %. A subsequent continence procedure was performed in 5 % of patients. This was not related to postoperative anterior compartment or apical prolapse and did not affect patient satisfaction. The role of posterior vaginal wall support in developing postoperative SUI needs further evaluation.
Int Urogynecol J Conflicts of interest None.
References 1. Dwyer PL (2012) Women with occult stress incontinence should not routinely have a mid-urethral sling with prolapse surgery. Int Urogynecol J 23:827–829. doi:10.1007/s00192012-1690-6 2. Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM, Pelvic Floor Disorders Network (2006) Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 354(15):1557–1566 3. Costantini E, Lazzeri M, Bini V, Del Zingaro M, Zucchi A, Porena M (2011) Pelvic organ prolapse repair with and without prophylactic concomitant Burch colposuspension in continent women: a randomized, controlled trial with 8-year followup. J Urol 185(6):2236–2240 4. Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P et al (1996) The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 175:10–17 5. Kelleher CJ, Cardozo LD, Khullar V, Salvatore S (1997) A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 104(12):1374–1379 6. Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S (2005) P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct 16:176–181
7. Sirikrishna S, Robinson D, Cardozo D (2010) Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J 21:523–528 8. Ulmsten U, Falconer C, Johnson P et al (1998) A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 9(4):210– 213 9. Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, Schluter P (2004) Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol 190:20–26 10. Schierlitz L, Dwyer PL, Rosamilia A et al (2010) A prospective randomized controlled study comparing vaginal prolapse repair with and without Tension free Vaginal Tape (TVT) in women with severe genital prolapse and occult stress incontinence. 3 year follow up. Int Urogynecol J 21(Suppl 1):S2 11. Malak M (2012) The role of anti-incontinence surgery in management of occult urinary stress incontinence. Int Urogynecol J 23:823– 825 12. Barber MD, Kuchibhatla MN, Pieper CF, Bump RC (2001) Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol 185:1388–1395 13. Wiskind AK, Creighton SM, Stanton SL (1992) The incidence of genital prolapse after the Burch colposuspension. Am J Obstet Gynecol 167(2):399–404 14. Schraffordt Koops S, Bisseling TM, Heintz PM et al (2005) Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study. Am J Obstet Gynecol 193:45–52 15. Wei J (2011) A midurethral sling prevents incontinence among women undergoing vaginal prolapse repair-the OPUS trial. Neurourol Urodyn 30:809–811
