Anal plugs for the management of fecal incontinence in children and adults: a randomized control trial. Anal plug for faecal incontinence. A new polyurethane anal plug in the treatment of incontinence after anal atresia repair. The urethral plug II: an alternative treatment in women with genuine urinary stress incontinence. Comparison of controlled-intermittent anal dilatation and lateral internal sphincterotomy in the treatment of chronic anal fissures: a prospective, randomized study. Elastomer implants in faecal incontinence: a blind, randomized placebo-controlled study. A randomized controlled trial of the NEAT expandable tip continence device. Randomized, controlled trial of anal electrical stimulation for fecal incontinence. Randomized clinical trial comparing conservative and surgical treatment of neurogenic faecal incontinence.
To evaluate the contribution of the anal plug to the management of fecal incontinence in children and adults.
                Effective management of fecal incontinence remains problematic. Previous studies of an anal plug have yielded conflicting results.
                A randomized controlled trial was conducted. The intervention was the Conveen anal plug (Coloplast Limited) used for 12 months. Outcomes measures included: generic measures of child health [Functional Status II-R, Child Health Questionnaire (CHQ-PF50) and Dartmouth Primary Care Cooperative Information Project Charts]; generic measures of adult health for patients and carers (the SF-36, and Patient Generated and Carer Generated indices); condition-specific measures for adults and children; qualitative interviews, bowel charts, and diaries. The main outcome measure was a condition-specific score on a 0 to 100 scale, where 0 was the most severe and 100 was the least severe incontinence.
                Thirty-one intervention and 17 control patients were recruited. Fecal incontinence was due to 1 of 3 reasons: congenital, acquired, and neurogenic. At baseline, patients managed their condition preemptively or protectively. Intervention patients used the plug as a complete management substitute or as an adjunct to existing management. The majority of intervention respondents retained the plug most of the time. There was greater improvement from baseline in mean condition-specific score in intervention group compared with control group but this difference was not statistically significant (t test P=0.053). Complete data analysis using analysis of covariance showed the mean difference between the treatment groups in condition-specific score of 9.9 (95% confidence interval-1.4, 21.1). Intention to treat analyses using imputation showed similar results. There was generally greater improvement in intervention groups subjects using other measures for children, adults, and carers.
                The anal plug is of benefit to the majority of patients. It does not suit all eligible patients with in situ plug retention being a problem for some. Despite the availability of pharmacological, behavioural and surgical treatments for faecal incontinence, many patients remain symptomatic. There are few devices designed specifically to cope with this, and perineal pads are inefficient and unacceptable for many patients. This study aimed to evaluate a new device in patients with intractable faecal incontinence.
                Two sizes of a purpose-designed anal plug were evaluated in 20 patients with intractable faecal incontinence for solid or liquid stool. Each plug size was tested for 2 weeks, with patients completing a structured questionnaire after each size.
                The majority [14/20] could not tolerate a plug due to discomfort. Four patients (20%) wished to continue to use a plug on a regular basis after the study, and two others on an occasional basis. However, for this minority who could tolerate a plug, it was highly successful at controlling faecal incontinence. There was no clear preference for the smaller or larger plug. There was no association between comfort in using the plug and anorectal sensitivity as measured by electrophysiological tests. It was not possible to predict which patients would benefit from plug use.
                The anal plug is effective in controlling faecal incontinence and is well tolerated in a minority of patients. Evaluation quickly reveals whether the patient will find it an effective and acceptable option. This device therefore offers a further management option for patients with faecal incontinence. 38 totally or partially incontinent patients following imperforate anus repair (age 6-15 years) tested a new polyurethane (PU) anal plug against another, widely used anal plug (PVA) in a randomized crossover trial. Plugs were tested 3 weeks each, data concerning bowel habits, handling and plug-related problems were collected by questionnaire before trial, at time of product change and after trial.
                15 of 38 patients did not complete the protocol, among them 6 with anal canal diameters too small for the smallest plug. During plug use, patients experienced enhanced awareness of repletion and urge. Stool consistence did not change in 82% of patients. There were no changes in children constipated prior to study (n = 8/23). 12,123 children were absolutely clean during use of either plug. 15 patients (68%) using the PU plug and 10 (45%) using the PVA plug felt secure from soiling during plug use. 74% of patients preferred the PU plug. Painful plug insertion, a feeling of pressure inside the anal canal and painful plug removal were reported with both plugs, but were less frequent with the PU plug.
                Anal plugs, regardless of their make, offer absolute cleanliness for periods of several hours to 66% of our incontinent patients. The PU plug (Conveen, Coloplast) is preferred by the patients and offers greater security than the PVA plug. An improved design of the recently developed urethral plug was evaluated for the treatment of women with genuine urinary stress incontinence. The plug consists of an oval meatal plate, a soft stalk and 1 or 2 spheres along the stalk with fixed distances between the meatal plate and the spheres. Inside the stalk is a removable semi-rigid guide pin to ease insertion. Forty women were randomly allocated to treatment with either the 2-sphere or the 1-sphere plug during period 1 (2 weeks). In period 2 (2 weeks) the patients used the other plug. They then continued with what they judged to be the better plug in period 3 (2 months). Eighteen patients (45%) completed period 3 with the "preference" plug and 17 were subjectively and objectively continent or improved. Fourteen of these women preferred the 2-sphere device. The plugs were equally effective in patients with mild or severe incontinence. To accommodate variations in urethral length and to avoid the loss of plugs, the devices are available in different lengths. Six women developed urinary tract infections and 2 of these had a plug in the bladder. The urethral plug is an effective treatment in a group of women with stress incontinence. Removal by hand is advisable in order to avoid retention of plugs in the bladder. The results of controlled-intermittent anal dilatation (CIAD) or lateral internal sphincterotomy (LIS) in the treatment of chronic anal fissures are presented.
                Forty patients who were randomized to two groups underwent CIAD or a LIS. The pre- and post-operative mean anal canal resting pressures (MACRPs) and symptoms were recorded and the results were compared.
                Two months post-operatively, 18 patients in the CIAD group and 17 patients in the LIS group had healed completely, and had no anal incontinence or other complications. The post-operative improvement in pain, bleeding, and constipation did not differ significantly between the two groups. In the CIAD and LIS groups, the pre-operative MACRPs were 89.7+/-16.5 and 87.6+/-12.3 mmHg, respectively; 2 months post-operatively, the MACRPs had significantly decreased to 76.9+/-13.7 and 78.1+/-11.3 mmHg in the CIAD and LIS groups, respectively. No statistical difference existed in the pre- or post-treatment MACRPs between the groups.
                CIAD applied with a standardized technique reduced anal canal resting pressure and provided symptomatic healing that was equivalent to a LIS. Since there were no findings of incontinence, or situations which resulted in sphincter damage, we conclude that CIAD is suitable for patients with chronic anal fissures because it is less invasive than LIS, with equivalent efficacy and safety. In addition, the CIAD method may be an alternative procedure in older and multiparous women who has a higher risk of incontinence. To test efficacy and safety of polydimethylsiloxane elastomer implants, a silicone biomaterial, in patients with severe faecal incontinence related to an impaired internal anal sphincter.
                Subjects were randomized to receive three injections of 2.5 mL of either physiological saline or polydimethylsiloxane elastomer. After local anaesthesia, an 18 gauge, 2.5-in needle was inserted through the perianal skin and laid down into the intersphincteric space. Treatment (saline or polydimethylsiloxane elastomer) was administered by means of a ratchet gun. Three injections of 2.5 mL each were performed in the area of the internal anal sphincter at 3, 7 and 11 o'clock positions. Main end point was the percentage of subjects in each treatment arm experiencing a successful treatment, defined as a Cleveland Clinic Florida-Faecal Incontinence score <8, 3 months after treatment. Secondary end points were quality of life scores, weekly number of faecal incontinence episodes, subject acceptance and adverse events rate. Both patients and end point assessments were blinded to treatment. Results: 44 women (64.3 +/- 9 years) with a baseline Cleveland Clinic Florida-Faecal Incontinence score > or =8 were enrolled prospectively; 22 received polydimethylsiloxane elastomer and 22 saline treatment. Treatment was well tolerated. At 3 months, the percentage of subjects experiencing a successful treatment was not different between polydimethylsiloxane elastomer and saline groups (23% vs. 27%, respectively, P = 0.73). Moreover, Cleveland Clinic Florida-Faecal Incontinence score was not significantly different between polydimethylsiloxane elastomer and saline groups (11.7 +/- 4.7 vs. 11.4 +/- 4.5, respectively, P = 0.79).
                Polydimethylsiloxane elastomer implants cannot be recommended for treatment of severe faecal incontinence related to impaired internal anal sphincter. Urethral devices are one conservative management option for stress and mixed urinary incontinence, but there is little published data about their use. The aims of this study were to assess the safety and efficacy of a new urethral device (NEAT) and compare it with the Reliance Insert. The ease of use of both devices was then evaluated. Twenty-four women with mixed or stress urinary incontinence, patients at our tertiary care urogynecology unit and who met the inclusion and exclusion criteria, were enrolled in the study. Study subjects were blinded and randomly assigned to a device group. Device efficacy was assessed by pad weighing at 0 and 4 months. Success was defined as a 50% or greater reduction in urine loss using the formula 100[(pad weight without device -pad weight with device)/pad weight with device]. Safety was evaluated using urinalysis and urine cultures. Ease of use assessment scales were also completed. Eleven patients were randomized to the Reliance Insert and 13 to the NEAT device. There were no significant differences between the two groups in age, height, weight, duration of incontinence, pad weight, leakage score, parity or quality of life score. Based on the pad weight success formula, there was no significant difference in device success between the two groups at 4 months. Women who were postmenopausal had a trend towards a higher level of success in reduction of their pad weight. Previous treatment, diagnosis and hormone replacement therapy all had no relationship to device success. Leakage score data showed that subjects had a significant decrease in urine leakage when using either device. There was no statistically significant difference in ease of use between the two devices. Adverse symptoms most commonly noted were awareness of the device (62.5%), urgency (29.2%), and urethral discomfort or pain (20.8%). One urinary tract infection (UTI) was observed. The most common finding on urinalysis was trace hematuria (15.8%). Our conclusions are that the NEAT device appears to be at least as effective and safe as the Reliance Insert. Both devices are effective at decreasing urine leakage in patients with stress or mixed urinary incontinence. The risk of UTI is low, but these devices may cause trace hematuria. Anal electric stimulation has been described as effective for fecal incontinence in several case series, but no study has addressed possible mechanism of benefit. We wished to examine whether anal electric stimulation, using an anal probe electrode, used on a daily basis at home for eight weeks, in the absence of any adjunctive exercises or advice, would improve symptoms of fecal incontinence and anal sphincter pressures when compared with "sham" electric stimulation.
                Ninety patients (9 males, 81 females), with median age of 55 (range, 30-77) years were randomized, 47 to active anal stimulation at 35 Hz and 43 to "sham" stimulation at 1 Hz. Outcome measures included a one-week bowel diary, symptom questionnaire, manometry, and patients' evaluation of outcome.
                Seventy patients completed the study. On an intention-to-treat analysis, there was no difference between the two groups on any of the outcome measures after eight weeks. Of those who completed stimulation, 44 (63 percent) felt the stimulation had improved their continence. Those with intact anal sphincters were not likely to rate their change more positively than those with sphincter disruption (P=0.71). Median patient rating of bowel control increased from 3 of 10 before stimulation to 5 of 10 after stimulation (P=0.001).
                Eight weeks of anal electric stimulation was rated by patients as having improved their bowel control to a modest extent. There was no statistically significant difference detected between the groups, suggesting that 1 Hz was as effective as 35 Hz. This raises the possibility that the main effect is not sphincter contraction but sensitization of the patient to the anal area, or simply the effect of intervening per se. Home electric stimulation is a relatively cheap and generally well-tolerated therapy in the conservative treatment of fecal incontinence. The treatment of choice in idiopathic (neurogenic) faecal incontinence is controversial. In a randomized study levatorplasty was compared with anal plug electrostimulation of the pelvic floor with respect to functional outcome and physiological variables.
                Thirty-one patients underwent levatorplasty and 28 anal plug electrostimulation of the pelvic floor over 3 years. The results were evaluated at 3, 12 and 24 months after completion of treatment by means of a validated questionnaire and anorectal manometry and manovolumetry.
                Incontinence scores were significantly reduced during the entire observation period in both groups (P < 0.001) as was the use of pads (P = 0.003 to P < 0.001). The proportion of patients reporting improvement in physical and social handicap was greater in the levatorplasty group after 3, 12 and 24 months (P = 0.036 to P < 0.001). No significant changes in physiological variables were observed in either group.
                Better results were obtained with levatorplasty than with anal plug electrostimulation of the pelvic floor in patients with idiopathic (neurogenic) faecal incontinence. Levatorplasty should be therefore be considered the treatment of choice for this condition.
                Copyright 2004 British Journal of Surgery Society Ltd.
The available data were limited and incomplete, and not all pre-specified outcomes could be evaluated. Consequently, only tentative conclusions are possible. The available data suggest that anal plugs can be difficult to tolerate. However, if they are tolerated they can be helpful in preventing incontinence. Plugs could then be useful in a selected group of people either as a substitute for other forms of management or as an adjuvant treatment option. Plugs come in different designs and sizes; the review showed that the selection of the type of plug can impact on its performance.