The influence of oestrogen replacement on faecal incontinence in postmenopausal women

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1 British Journal of Obstetrics and Gynaecology March 1997,Vol. 104,~~ The influence of oestrogen replacement on faecal incontinence in postmenopausal women *Valerie Donnelly Research Fellow, tp. Ronan O Connell Colorectal Surgeon, *Colm O Herlihy Professor *Department of Obstetrics and Gynaecoloa8 University College DubIin, National Maternity Hospital; fdepartment of Surgery, Mater Misericordiae Hospital, Dublin, Ireland Objective To assess the value of hormone replacement therapy (HRT) in postmenopausal women with faecal incontinence. Design Prospective observational study using a bowel function questionnaire and anorectal physiological testing before and after six months of standard oestrogen hormone replacement therapy. Setting Menopause and colorectal clinics of two university teaching hospitals. Participants Twenty postmenopausal women (mean age 61 years) with demonstrable faecal incontinence (mean duration 6.1 years) previously untreated with HRT. Main outcome measures Improvement in symptoms and objective alteration in anorectal physiology tests. Results All women had significant symptoms of anorectal dysfunction before treatment, whereas 5/20 (25%) were asymptomatic after six months of HRT, and a further 13/20 (65%) were symptomatically improved in terms of flatus control, urgency, and faecal staining. There was no change in bowel fiequency or stool consistency following HRT, but social activity was considerably improved. Anal resting pressures and voluntary squeeze increments were significantly increased following oestrogen therapy, although no differences in anal canal vector symmetry index were observed. Insignificant changes occurred in threshold volume of rectal sensation and volume of defaecatory urge, but there was a significant change in maximum tolerated rectal volume after six months. Neither anal canal electrosensitivity nor pudendal nerve terminal motor latency was altered following HRT. Seven of the 20 women (35%) had an identifiable anal sphincter defect on anal endosonography. Statistical analysis, however, showed no significant difference in outcome in this group compared with those with an intact anal sphincter. A larger population sample may demonstrate this. Conclusion This observational study has shown a possible benefit of oestrogen replacement in postmenopausal women with symptoms of impaired faecal continence. A prospective randomised controlled trial is now advisable to test this hypothesis. INTRODUCTION Faecal incontinence is a very unpleasant and debilitating symptom which occurs predominantly in postmenopausal women. The sex ratio shows a female to male preponderance of 8: 1, and most affected women are parous l. While faecal incontinence may occur following obstetric in the majority of sufferers symptoms become manifest after the menopause, probably because of the effects of ageing and the hypo-oestrogenic status of the nerves, muscles and ligaments of the pelvis and of the anorectal supporting tissues. This clinical pattern suggests that cumulative obstetric injury4 is compensated by the Correspondence: Professor C. O Herlihy, Department of Obstetrics and Gynaecology, University College Dublin, National Maternity Hospital, Holles Street, Dublin 2, Republic of Ireland. integrity of pelvic floor connective tissues until trophic oestrogen support declines with the cessation of reproductive ovarian function. We designed this study to evaluate prospectively both the symptomatic and objective effects of a standard oestrogen/ progestogen hormone replacement regimen on anorectal function and continence in a cohort of postmenopausal, oestrogen-deficient women suffering from faecal incontinence. METHODS Twenty women with established faecal incontinence (mean duration 6.1 years) were recruited from gynaecological, menopause, and coloproctology clinics of the National Maternity and Mater Misericordiae Hospitals. The average age was 61 years (range 0 RCOG 1997 British Journal of Obstetrics and Gynaecology 311

2 ~ ~~ ~ 312 v. DONNELLY ET AL. Table 1. Continence grading score. Continence score (adapted from Pescatori et az23) with total score determined by adding points from the grid; a score of zero implies complete continence and 20 total incontinence. Type of incontinence Never Monthly Weekly Daily Always Solid Liquid Flatus Soiling Alters lifestyle ), and all were postmenopausal (average duration 8.3 years) and oestrogen-deficient (serum oestradiol < 50 pg/ml). Women with diabetes mellitus, neurological disorders or previous anorectal surgery were excluded. Four women who had undergone hysterectomy one to eight years before the study were given an oestrogen patch for six months while the remaining 16 women received a combination of oestrogen patch (50 kgm oestradiol per 24 h) and oral progestogen (norethisterone acetate 1 mg daily for 12 days per cycle) (Estrapak, Ciba Geigy, Basel, Switzerland). Each woman completed a detailed bowel function questionnaire and both obstetric and menopausal histories were recorded. The bowel hction questionnaire recorded details of difficulty with defaecation; incontinence of flatus; liquid stool or solid stool; faecal staining of underwear; defaecatory urgency of less than five minutes; discomfort with defaecation; digital manipulation to complete defaecation; bowel frequency; normal stool consistency; and urinary incontinence. A continence grading score was used to score incontinence (Table 1). Visual analogue scoring (VAS) was used to assess the influence of incontinence on daily and social activities. A sexual finction questionnaire was abandoned because only 20% women were sexually active at the time of study. Anorectal physiology was tested unblinded before and after six months HRT, consisting of anal manometry, anal endosonography and measurement of rectal sensation, anal electrosensitivity, and pudendal nerve terminal motor latency. Anal manometry was performed using a single channel, micro transducer (Gaeltec, Isle of Skye) and a station pull-through technique radially in eight planes to assess radial symmetry. Average and maximum resting pressures and voluntary squeeze increment pressures were measured and an index of the symmetry of the pressures within the canal, the vector symmetry index (VSI), calculateds. Rectal sensation to distension was studied by inflating a latex balloon with 20 ml increments of Table 2. Details of symptoms of incontinence before and after hormone replacement therapy. NS = not significant. Values are given as numbers of women. Symptoms of incontinence Before HRT After HRT P* Difficulty with defaecation 5 Incontinence To flatus 15 To liquid stool 12 To solid stool 6 Faecal staining of underwear 10 Urgency of defaecation 13 Digital manipulation 5 *Comparison using Yates corrected x2 test. 2 NS NS 3 NS NS air in the rectum at one-minute intervals. The volumes producing first sensation (sensory threshold), sensation of faecal urgency, and maximum tolerated volumes were recorded6. Anal electrical mucosal sensory threshold was measured using a bipolar ring electrode (Dantec 21 L10 Skovlunde, Denmark) mounted on a 10-gauge Foley catheter2. Sensitivity of the upper and lower anal canal mucosa to electrical stimulation was recorded by placing the catheter in the anal canal 1 cm distal to the rectal verge, and a second measurement was taken 1 cm proximal to the anal verge. A small pulsed electric current from a square wave generator (Medelec MS92, Woking, UK) was passed across the electrodes. The current was increased at five-second intervals and 0.1 ma increments. The minimum current in milliamps (ma) required to produce awareness of a tingling feeling was recorded on three occasions and the lowest value was deemed to constitute the threshold of anal sensation. Pudendal nerve terminal motor latency (PNTML) was measured using a disposable, finger mounted St Mark's pudendal electrode (Dantec, Skovlude, Denmark)7. A stimulus of 50 V for 0.1 ms was delivered at one pulse per second and the shortest reproducible latency recorded on a MS91 EMG machine (Medelec, Old Woking, Surrey, UK)*. Anal endosonography was performed using a Toshiba 120" sector probe with a 5 MHz transducer (Toshiba PVL516 S, Tokyo, Japan). Images of the upper, middle, and lower canal were recorded in four overlapping quadrants. The results were interpreted by two radiologists unaware of the woman's history or clinical findings9. Statistical analysis was performed comparing results before and after HRT using a Wilcoxon matched pairs sign rank test and the paired Student's t test, with significance assessed at the 5% level. The change in anorectal physiology following six months 0 RCOG 1997 Br J Obstet Gynaecol 104,

3 VALUE OF HRT FOR FAECAL INCONTINENCE 313 Table 3. The results of visual analogue scores (VAS) for social and daily activity and continence score in women before and after six months hormone replacement therapy. Values are given as median (interquartile range). Before HRT After HRT P* VAS social activity 6 ( ) 2 ( ) VAS daily activity 6 ( ) 2 ( ) Continence score 15 (13-17) 8 (3 3-11) *Comparison by Wilcoxon matched-pairs test. Table 4. The comparative results of anal physiology testing before and after 6 months hormone replacement therapy (n = 20). BD = balloon distension. MTV = maximum tolerated volume. ES = electrosensitivity. NTL = nerve terminal latency. Before HRT After HRT (t) P* Anal manometry (mmhg) Resting pressure 33.4 (3.0) 40.0 (2.3) (5.4) Squeeze pressure 39.0 (9.4) 43.0 (8.7) (2.3) 0.03 Rectal sensation to BD (ml) Threshold 106(10.0) 99(8.0) (1.8) 0.9 Urge 149 (10.0) 138 (8.0) (0.8) 0.4 MTV 187 (12.8) 170 (12.2) (3.3) 0,004 Anal canal ES (ma) Upper 5.3 (0.4) 5.2 (0.5) (0.2) 0.9 Lower 4.4 (0.3) 4.1 (0.2) (1.0) 0.3 Pudendal NTL (ms) Right 2.45 (0.08) 2.5 (0.07) (0.7) 0.5 Left 2.46 (0.08) 244 (0.07) (0.2) 0.8 *Values are expressed as mean (SEM). Paired Student s t test. of HRT in those women with and without anal sphincter defects was assessed using an unpaired Student s t test. The study was approved by the Ethics Committees of the National Maternity and Mater Misericordiae Hospitals, and all women provided written informed consent. RESULTS All 20 women completed the study. A majority of the women (12/20) reported that their incontinence had worsened following the menopause, while two related the onset to hysterectomy, and only one to childbirth. The remaining five women could not identify any specific event which corresponded with the appearance of symptoms. All 20 women were parous, with a mean parity of 4.5 (range 3 to 8), but only five recalled experiencing difficulty with obstetric deliveries, such as prolonged labour, forceps deliveries, or severe perineal tears. The results of the symptom questionnaire are detailed in Table 5. Analysis of change in anorectal function following 6 months of hormone replacement therapy, comparing women with (n = 7) and without (n = 13) a defect on anal endosonography. SD = sphincter defect. NSD = no sphincter defect. BD = balloon distenstion. MTV = maximum tolerated volume. SD NSD Mean (SEM) Mean(SEM) P* Change in anorectal function following 6 months of HRT Incontinence score 5.0 (1.2) 8.6 (1.0) 0.06 Visual assessment scores (VAS) Social activity 4.0 (1.0) 3.6 (0.3) 0.10 Daily activity 3.0 (0.95) 3.8 (0.4) 0.20 Anal manometry (mmhg) Resting 8.5 (1.3) 6.2 (1.7) 0.50 Squeeze 5.0 (2.1) 3.2 (2.1) 0.60 Rectal sensation to BD (ml) MTV 18.5 (4.5) 17.0 (8.0) 0.3 Urgency 7.0 (5.0) 12.7 (8.0) 0.2 Threshold 3.5 (5.0) 9.2 (6.0) 0.20 *Values are expressed as mean (SEM).*Unpaired Student s t test. Table 2; 18 (90%) experienced some improvement in their symptoms following six months of HRT and five (25%) became symptom-free. No change was reported in evacuation frequency or consistency of stool. HRT nevertheless was associated with a significant improvement in continence score and with benefits in both social and daily activity (Table 3). Significant increases were found in mean resting anal canal pressure, maximum resting pressure and in mean maximum voluntary squeeze increment following oestrogen therapy. There was no alteration in vector symmetry index. There was a significant increase in the maximum tolerated rectal volume, but no change in the threshold volume of rectal sensation and the volume of defaecatory urge (Table 4). There was no difference in anal canal electrosensitivity or in PNTML following six months of HRT. Anal endosonography revealed that seven women (30%) had a previously unsuspected anal sphincter defect. Improvement in anorectal physiology was not significantly different in this subgroup compared with those with an intact anal sphincter (Table 5), although there was an overall improvement in manometric results in both subgroups. DISCUSSION These results demonstrate in a preliminary observational study, a previously unreported beneficial effect of HRT in postmenopausal women with faecal incontinence. Symptoms of defaecatory urgency, faecal staining, and flatus control were most 0 RCOG 1997 Br J Obstet Gynaecol 104,

4 314 v. DONNELLY ET AL. improved. These are the so-called minor symptoms of incontinence, but are greatly debilitating. Part of this apparent beneficial effect might be the result of an improved sensation of wellbeing associated with increased circulating oestrogens. However, in this study we have also demonstrated an objective improvement in anorectal manometry confirming a coincident functional physiological change. Faecal incontinence is most prevalent in elderly women, many of whom live in institutional care. With an increasing population of elderly women in our society the problem of faecal incontinence is likely to increase. Women are reluctant to volunteer symptoms of faecal incontinencelo and those attending for consultation about the menopause do not volunteer bowel symptoms unless directly questioned. We have found that 4% of women attending at the National Maternity Hospital menopause clinic experience faecal incontinence of some degree and in the majority their symptoms have deteriorated since the cessation of menses. Several studies have shown a decrease in resting anal canal pressures with Resting pressure is chiefly the result of internal sphincter tone15, and it has therefore been postulated that this is due to the effects of age on the autonomic nervous system, or to an alteration in the viscoelastic properties of the anal sphincteri6. We have demonstrated an increase in anal canal pressure following HRT and suggest that this is due to an increase in the collagen and elastic content of the pelvic floor. Skin and subcutaneous collagen increase in women taking oestrogen replacement. Anal squeeze pressures are also known to decline with age, mostly in the fifth and sixth decades *, and to a greater degree in women than in menlg. Poor anal squeeze pressures are associated with faecal incontinence, and we have demonstrated a modest rise in anal squeeze pressures following six months of hormone replacement therapy. Laurberg and SwashIg suggest that the menopause may play a role in differences in the ageing phenomenon as seen in pelvic floor physiology between men and women. There is supportive evidence for a hormone dependent factor in the pelvic floor muscle from histometric studies20. There is evidence to suggest that the proximal urethra is influenced by oestrogen, and that oestrogen replacement is beneficial to patients with sensory urge incontinence of urine21. In our view, a similar benefit may apply to the rectum and anus, a benefit which is not unexpected, since oestrogen receptors are preferentially present in external anal sphincter tissue in women22. A prospective randomised placebo-controlled trial is now advisable to test the hypothesis that HRT will benefit women with faecal incontinence. This observational study suggests that in older women with faecal incontinence, anal endosonography is advisable prior to HRT to determine the presence of anal sphincter defects, as these patients may benefit less from oestrogen replacement and should be considered for anal sphincter repair. Acknowledgements V. Donnelly was funded by the Research Colleges of the National Maternity, and Mater Hospitals, and also by Ciba-Geigy. We are grateful to the Master and consultants and colleagues for permission to study their patients and to Dr M. Fynes for her assistance in analysis of these data. References Thomas TM, Ruff C, Kanan 0, Mellows S, Meade TW. Study of the prevalence and management of patients with faecal incontinence in old people s homes. CommunivMed 1987; 9: Comes H, Bartolo Dc, Stirrat GM. Changes in anal canal sensation after childbirth. BrJSurg 1991; 78: Sultan AH, Kamm MA, Hudson CN, Thomas JM, Bartram CI. Analsphincter disruption during vaginal delivery. NEngl JMed 1993; 329: Snooks JJ, Swash M, Mathers SE, Henry MM. Effect of vaginal delivery in the pelvic floor, a five year follow-up. Br JSurg 1990; 77: Perry RE, Blatchford GJ, Christensen MA, Thorson AG, Attwood SE. Manometric diagnosis of anal sphincter injuries. Am J Surg 1990; 159: Sorensen M, Rasmussen 00, Tetzschner T, Christiansen J. Physiological variation in rectal compliance. Br J Surg 1992; 79: Rogers J, Hemy MM, Misiewicz JJ. Disposable pudendal nerve stimulation: evaluation of the standard instrument and new device. Gut 1988; 29: Snooks JJ, Swash M. Nerve stimulation techniques In: Henry MM, Swash M, editors. Coloproctology and the Pelvic Floor. London: Buttenvorths, 1985: Campbell DM, Behan M, Donnelly VS, O Herlihy C, O Connell PR. Endosonographic assessment of postpartum anal sphincter injury using a 120 degree sector scanner. Clin Radio1 1996; 51: Leigh RJ, Tumberg LA. Faecal incontinence: the unvoiced symptom. Lancet 1982; 1: I1 Matheson DM, Keighley MR, Manometric evaluation of rectal prolapse and faecal incontinence. Gut 1981; 22: Barrett JA, Brocklehurst JC, Kiff ES, Ferguson G, Faragher EB. Anal function in geriatric patients with faecal incontinence. Gut 1989; 30: Enck P, Kyhlbusch R, Lubke H, Frieling T, Erkenbrecht JF. Age and sex and anorectal manometry in incontinence. Dis Colon Rectum 1989; 32: Ackervall S, Nordgiven S, Farth S, Ovesland T, Pettersson K, Huh L. The effects of age, gender, and parity on rectoanal functions in adults, Scand JGastroenierol1990; Frenckner B, Erler CV. Influence of pudendal block on the function of the anal sphincter. Gut 1975; 16: Jameson JS, Kamm MA, Speakman CT, Chye YH, Henry MM. Effects of age, sex, and parity on anorectal function. Br JSurg 1994; 81: Brincat M, Monk CF, Studd JWW, Darby AJ, Magos A, Cooper D. Sex hormones and skin collagen content in postmenopausal women. BMJ 1983; 287: Laurberg S, Swash M. Effects of aging on the anorectal sphincters and their innervation. Dis Colon Rectum 1989; 32: RCOG 1997 Br J Obstet Gynaecol 104,

5 VALUE OF HRT FOR FAECAL INCONTINENCE Henry MM, Simson JNL. Results of postanal repair: a retrospective study.brjsurg 1985; 72: S17-Sl9. 20 Beersiek KF, Parks AG, Swash M. Pathogenesis of anorectal incontinence; a histometric study of the anal sphincter musculature. JNeurol Sci 1979; 42: Versi E. Incontinence in the climacteric. CIin Obsrer Gynaecol 1990; 33: Haadem K, Ling L, Femo M, Grafier H. Oestrogen receptors in the external anal sphincter Am JObsrer Gynecoll991; 164: Pescatori M, Anastasio G, Bottini C, Mentasti A. New grading and scoring for anal incontinence. Evaluation of 335 patients. Dis Colon Rectum 1992; 35: Received I1 December 1995 Returned for revision 9 February 1996 Revised version received 22 July I996 Accepted 5 September RCOG 1997 Br J Obstet Gynaecol 104,

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