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Active sacral neuromodulator during pregnancy: a unique case report Q5 Q1 Apostolos
Mamopoulos, MD, PhD; Thomas Stavrakis, MD; Georgios Mavromatidis, MD, PhD; David Rousso, MD, PhD
U
rinary incontinence may become a serious problem by affecting the quality of life in a substantial number of people, especially women. A multicomponent approach is usually the ideal method, but even then the annual remission rate ranges from 0e13%.1 Detrusor and/or urethral sphincter hyperactivity may be a cause of incontinence and of chronic nonobstructive urinary retention as a result of chronic detrusor-sphincter dyssynergia. Sacral neuromodulation is a system approved by the US Food and Drug Administration for the treatment of urge incontinence and chronic urinary retention that are refractory to other treatments.2 The mechanism is based on the electric stimulation of the S3 and S4 nerves; however, its exact mechanism of action is not known. Both the bladder function and the function of the surrounding muscles may be influenced and lead to an improvement of the urinary function.3 This device consists of an implanted lead that lies along a sacral nerve root and is connected to an implanted pulse generator. A patient programmer is also available and allows the discontinuation of the device at any time. The alternative treatment options for those kinds of urinary dysfunctions are limited to bladder surgery, absorbent pads, and self-catheterization.
From the 3rd Department of Obstetrics & Gynecology, Aristotle University of Thessaloniki, Greece. Received Feb. 26, 2014; revised March 24, 2014; accepted April 9, 2014. The authors report no conflict of interest. Reprints: Thomas Stavrakis, MD, Resident in Obstetrics-Gynecology, 3rd Department of Obstetrics & Gynecology, Aristotle University of Thessaloniki Thessaloniki, Greece. tstavrakis@ gmail.com. 0002-9378/$36.00 ª 2014 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2014.04.015
Sacral neuromodulation with an implanted device is used in patients who experience urinary retention and malfunctioning overactive bladder where conservative treatment is not sufficient. The knowledge of its effect on pregnancy is not known. This article presents the case of a 34-year-old pregnant woman with an implanted device, the use of which was not discontinued during her pregnancy. Full-term pregnancy was achieved, and a healthy child was delivered by cesarean section. Sacral neuromodulation during pregnancy appears to be safe and may be preferable to intermittent bladder catheterizations that increase the chance of urinary infections. Key words: pregnancy, sacral neuromodulation, teratogenic, urinary dysfunction
C ASE R EPORT We present the case of a 34-year-old pregnant woman with chronic urinary retention. The urinary dysfunction was caused by an electrical spinal cord injury approximately 10 years before her pregnancy. Initially, intermittent bladder self-catheterization was used; however, because of frequent episodes of urinary tract infections, her urologist recommended sacral neuromodulation. When she became pregnant, the unknown effects of the device and the increased possibility of premature labor were explained to her; she decided not to deactivate the device fearing that intermittent selfcatheterization might lead, once more, to recurrent urinary infections. The risks of urinary tract infections from discontinuing sacral modulation balanced with the potential issues with neuromodulation were discussed with the patient. Her pregnancy was uneventful with no signs of threatened preterm labor. The anomaly ultrasound scan that was performed at 22 weeks’ gestation revealed no obvious anatomic abnormality of the fetus. Her urinary output remained within normal limits, and urinary infections were not detected. At 39 weeks gestation, a healthy male infant was delivered by cesarean section with peridural anesthesia because of breech presentation. There were no issues caused by the neuromodulator to the
anesthesiology procedure and no changes to the positioning of the patient during surgery. Sacral neuromodulation was active throughout the pregnancy and postpartum, and no issues were raised regarding malfunction or displacement of the device.
C OMMENT Sacral neuromodulation therapy helps control urinary dysfunctions through an implanted device that sends mild electrical impulses through a lead to the sacral nerves that innervate the bladder, sphincter, and pelvic floor. It is indicated for the treatment of urinary retention, urge incontinence, overactive bladder, and significant symptoms of urgencyfrequency. Self-catheterization, absorbable pads, and bladder surgery are the alternative treatments for this kind of urinary dysfunctions. A peripheral nerve stimulation test is performed to the patients before implantation to measure the feedback of the sacral neuromodulation. Local anesthesia is provided through a needle that is used to recognize the appropriate sacral nerves. After the successful identification, a temporary wire lead is entered through the needle and connected to an external device, which is placed on the patient and left there for several days. The results provided by the test are measured to determine whether
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www.AJOG.org
the patient is suitable for this treatment. The implantation of a permanent device is performed under general anesthesia through 3 incisions. The pulse generator is programmed with the ideal settings for the patient who can turn on and off the pulse generator. The use of sacral neuromodulation during pregnancy is very uncommon, most likely because of the rarity of bladder dysfunction during the reproductive years of a woman. Consequently, the experience of the effects of this treatment on pregnancy is limited. There is a theoretic risk of teratogenic effect on the developing fetus and a not so theoretic risk of preterm labor because the uterus and the bladder may share the same nerve roots. Review of the relevant literature revealed only 1 article that concluded that a sacral neuromodulation device should be deactivated during pregnancy because the effect on the fetus is unpredictable.4 Therefore, the International Urogynecological Association has advised women to deactivate their pulse generator as soon as their pregQ2 nancy is diagnosed.4 The alternative methods to handle urinary dysfunction without sacral neuromodulation are self-urinary catheterization, lifetime absorbable pads, and bladder surgery. Self-urinary catheterization is performed widely by patients when there are contraindications for sacral neuromodulation, but urinary infections are a frequent complication of this method.5 Six cases of pregnant women with a pulse generator are reported in the
literature. In all these cases, the device was deactivated between fourth and ninth gestational weeks. There were no obvious teratogenic effects, but premature birth at 34 weeks gestation was noted in one case.6 Khunda et al7 studied 13 pregnancies of women with sacral neuromodulation and came to the conclusion that turning off the neuromodulation is associated with an increased risk of urinary tract infection recurrence and furthermore preterm delivery. This is the first case, to our knowledge, in which the sacral neuromodulator remained active throughout the pregnancy. The challenge for the obstetric team was to manage the pregnancy without turning off the device, according to her personal wish. Urinary tract infection is the most common complication in patients performing intermittent catheterization and, apart from the discomfort, can predispose to preterm labor.6,8 Nevertheless, the pregnancy was uneventful and a healthy term male infant was born. A cesarean section delivery was performed because of breech presentation. Even though the IGUA suggests that sacral neuromodulation is not an indication for elective cesarean delivery, there is uncertainty on that issue because normal labor theoretically can cause displacement of the device.8 The use of sacral neuromodulation also extends to the treatment of bowel dysfunction, which makes its use during pregnancy more crucial.9 The continuous use of sacral neuromodulation during pregnancy is not
necessarily harmful to the fetus, and the risk of preterm labor appears to be theoretic. However, the number of such cases is very limited and prevents investigators from reaching a safe conclusion or issuing guidelines.
REFERENCES 1. Thuroff JW, Abrams P, Andersson KE, et al. EAU guidelines on urinary incontinence. Eur Urol 2011;59:387-400. 2. Comiter CV. Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study. J Urol 2003;169: 1369-73. 3. Groen J, Blok BF, Bosch JL. Sacral neuromodulation as treatment for refractory idiopathic urge urinary incontinence: 5-year results of a longitudinal study in 60 women. J Urol 2011;186:954-9. 4. International Urogynecological Association. Sacral neuromodulation: a guide for women [press release]. Washington, DC: IUGA; 2013. Q3 5. Wyndaele JJ. Complications of intermittent catheterization: their prevention and treatment. Spinal Cord 2002;40:536-41. 6. Wiseman OJ, v d Hombergh U, Koldewijn EL, Spinelli M, Siegel SW, Fowler CJ. Sacral neuromodulation and pregnancy. J Urol 2002;167: 165-8. 7. Khunda A, Karmarkar R, Abtahi B, Gonzales G, Elneil S. Pregnancy in women with Fowler’s syndrome treated with sacral neuromodulation. Int Urogynecol J 2013;24: 1201-4. 8. Hackenhaar AA, Albernaz EP, Fonseca TM. Preterm premature rupture of the fetal membranes: association with sociodemographic factors and maternal genitourinary infections. J Pediatr (Rio J) 2014;90:197-202. 9. Noblett KL, Cadish LA. Sacral nerve stimulation for the treatment of refractory voiding and bowel dysfunction. Am J Obstet Gynecol 2014;210:99-106.
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www.AJOG .org
Active sacral neuromodulator during pregnancy: a unique case report Q5 Q1 Apostolos
Mamopoulos, MD, PhD; Thomas Stavrakis, MD; Georgios Mavromatidis, MD, PhD; David Rousso, MD, PhD
U
rinary incontinence may become a serious problem by affecting the quality of life in a substantial number of people, especially women. A multicomponent approach is usually the ideal method, but even then the annual remission rate ranges from 0e13%.1 Detrusor and/or urethral sphincter hyperactivity may be a cause of incontinence and of chronic nonobstructive urinary retention as a result of chronic detrusor-sphincter dyssynergia. Sacral neuromodulation is a system approved by the US Food and Drug Administration for the treatment of urge incontinence and chronic urinary retention that are refractory to other treatments.2 The mechanism is based on the electric stimulation of the S3 and S4 nerves; however, its exact mechanism of action is not known. Both the bladder function and the function of the surrounding muscles may be influenced and lead to an improvement of the urinary function.3 This device consists of an implanted lead that lies along a sacral nerve root and is connected to an implanted pulse generator. A patient programmer is also available and allows the discontinuation of the device at any time. The alternative treatment options for those kinds of urinary dysfunctions are limited to bladder surgery, absorbent pads, and self-catheterization.
From the 3rd Department of Obstetrics & Gynecology, Aristotle University of Thessaloniki, Greece. Received Feb. 26, 2014; revised March 24, 2014; accepted April 9, 2014. The authors report no conflict of interest. Reprints: Thomas Stavrakis, MD, Resident in Obstetrics-Gynecology, 3rd Department of Obstetrics & Gynecology, Aristotle University of Thessaloniki Thessaloniki, Greece. tstavrakis@ gmail.com. 0002-9378/$36.00 ª 2014 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2014.04.015
Sacral neuromodulation with an implanted device is used in patients who experience urinary retention and malfunctioning overactive bladder where conservative treatment is not sufficient. The knowledge of its effect on pregnancy is not known. This article presents the case of a 34-year-old pregnant woman with an implanted device, the use of which was not discontinued during her pregnancy. Full-term pregnancy was achieved, and a healthy child was delivered by cesarean section. Sacral neuromodulation during pregnancy appears to be safe and may be preferable to intermittent bladder catheterizations that increase the chance of urinary infections. Key words: pregnancy, sacral neuromodulation, teratogenic, urinary dysfunction
C ASE R EPORT We present the case of a 34-year-old pregnant woman with chronic urinary retention. The urinary dysfunction was caused by an electrical spinal cord injury approximately 10 years before her pregnancy. Initially, intermittent bladder self-catheterization was used; however, because of frequent episodes of urinary tract infections, her urologist recommended sacral neuromodulation. When she became pregnant, the unknown effects of the device and the increased possibility of premature labor were explained to her; she decided not to deactivate the device fearing that intermittent selfcatheterization might lead, once more, to recurrent urinary infections. The risks of urinary tract infections from discontinuing sacral modulation balanced with the potential issues with neuromodulation were discussed with the patient. Her pregnancy was uneventful with no signs of threatened preterm labor. The anomaly ultrasound scan that was performed at 22 weeks’ gestation revealed no obvious anatomic abnormality of the fetus. Her urinary output remained within normal limits, and urinary infections were not detected. At 39 weeks gestation, a healthy male infant was delivered by cesarean section with peridural anesthesia because of breech presentation. There were no issues caused by the neuromodulator to the
anesthesiology procedure and no changes to the positioning of the patient during surgery. Sacral neuromodulation was active throughout the pregnancy and postpartum, and no issues were raised regarding malfunction or displacement of the device.
C OMMENT Sacral neuromodulation therapy helps control urinary dysfunctions through an implanted device that sends mild electrical impulses through a lead to the sacral nerves that innervate the bladder, sphincter, and pelvic floor. It is indicated for the treatment of urinary retention, urge incontinence, overactive bladder, and significant symptoms of urgencyfrequency. Self-catheterization, absorbable pads, and bladder surgery are the alternative treatments for this kind of urinary dysfunctions. A peripheral nerve stimulation test is performed to the patients before implantation to measure the feedback of the sacral neuromodulation. Local anesthesia is provided through a needle that is used to recognize the appropriate sacral nerves. After the successful identification, a temporary wire lead is entered through the needle and connected to an external device, which is placed on the patient and left there for several days. The results provided by the test are measured to determine whether
MONTH 2014 American Journal of Obstetrics & Gynecology CRP 5.2.0 DTD YMOB9784_proof 16 May 2014 3:26 pm ce
e1
56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110
Case Report 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166
www.AJOG.org
the patient is suitable for this treatment. The implantation of a permanent device is performed under general anesthesia through 3 incisions. The pulse generator is programmed with the ideal settings for the patient who can turn on and off the pulse generator. The use of sacral neuromodulation during pregnancy is very uncommon, most likely because of the rarity of bladder dysfunction during the reproductive years of a woman. Consequently, the experience of the effects of this treatment on pregnancy is limited. There is a theoretic risk of teratogenic effect on the developing fetus and a not so theoretic risk of preterm labor because the uterus and the bladder may share the same nerve roots. Review of the relevant literature revealed only 1 article that concluded that a sacral neuromodulation device should be deactivated during pregnancy because the effect on the fetus is unpredictable.4 Therefore, the International Urogynecological Association has advised women to deactivate their pulse generator as soon as their pregQ2 nancy is diagnosed.4 The alternative methods to handle urinary dysfunction without sacral neuromodulation are self-urinary catheterization, lifetime absorbable pads, and bladder surgery. Self-urinary catheterization is performed widely by patients when there are contraindications for sacral neuromodulation, but urinary infections are a frequent complication of this method.5 Six cases of pregnant women with a pulse generator are reported in the
literature. In all these cases, the device was deactivated between fourth and ninth gestational weeks. There were no obvious teratogenic effects, but premature birth at 34 weeks gestation was noted in one case.6 Khunda et al7 studied 13 pregnancies of women with sacral neuromodulation and came to the conclusion that turning off the neuromodulation is associated with an increased risk of urinary tract infection recurrence and furthermore preterm delivery. This is the first case, to our knowledge, in which the sacral neuromodulator remained active throughout the pregnancy. The challenge for the obstetric team was to manage the pregnancy without turning off the device, according to her personal wish. Urinary tract infection is the most common complication in patients performing intermittent catheterization and, apart from the discomfort, can predispose to preterm labor.6,8 Nevertheless, the pregnancy was uneventful and a healthy term male infant was born. A cesarean section delivery was performed because of breech presentation. Even though the IGUA suggests that sacral neuromodulation is not an indication for elective cesarean delivery, there is uncertainty on that issue because normal labor theoretically can cause displacement of the device.8 The use of sacral neuromodulation also extends to the treatment of bowel dysfunction, which makes its use during pregnancy more crucial.9 The continuous use of sacral neuromodulation during pregnancy is not
necessarily harmful to the fetus, and the risk of preterm labor appears to be theoretic. However, the number of such cases is very limited and prevents investigators from reaching a safe conclusion or issuing guidelines.
REFERENCES 1. Thuroff JW, Abrams P, Andersson KE, et al. EAU guidelines on urinary incontinence. Eur Urol 2011;59:387-400. 2. Comiter CV. Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study. J Urol 2003;169: 1369-73. 3. Groen J, Blok BF, Bosch JL. Sacral neuromodulation as treatment for refractory idiopathic urge urinary incontinence: 5-year results of a longitudinal study in 60 women. J Urol 2011;186:954-9. 4. International Urogynecological Association. Sacral neuromodulation: a guide for women [press release]. Washington, DC: IUGA; 2013. Q3 5. Wyndaele JJ. Complications of intermittent catheterization: their prevention and treatment. Spinal Cord 2002;40:536-41. 6. Wiseman OJ, v d Hombergh U, Koldewijn EL, Spinelli M, Siegel SW, Fowler CJ. Sacral neuromodulation and pregnancy. J Urol 2002;167: 165-8. 7. Khunda A, Karmarkar R, Abtahi B, Gonzales G, Elneil S. Pregnancy in women with Fowler’s syndrome treated with sacral neuromodulation. Int Urogynecol J 2013;24: 1201-4. 8. Hackenhaar AA, Albernaz EP, Fonseca TM. Preterm premature rupture of the fetal membranes: association with sociodemographic factors and maternal genitourinary infections. J Pediatr (Rio J) 2014;90:197-202. 9. Noblett KL, Cadish LA. Sacral nerve stimulation for the treatment of refractory voiding and bowel dysfunction. Am J Obstet Gynecol 2014;210:99-106.
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