CLINICAL STUDY SUMMARIES
Radiofrequency Anal Sphincter Remodeling (Secca) versus Biofeedback for the treatment of Fecal Incontinence: Anorectal Motility & Clinical Results.
Herman, Roman M.; Nowakowski, Michal; Herman, Roma B. Jagiellonian University, Krakow, Poland. Presented at DDW 2011.
BACKGROUND & AIMS: Radiofrequency Anal Sphicter Remodeling (SECCA) has been proposed as noninvasive fecal incontinence (FI) treatment but has not been compared with behavioral treatment (biofeedback).The aim of this study was clinical & physiological evaluation of the anorectal function prior and 12 months after Secca procedure as compared to 6 months biofeedback training.
MATERIAL: Forty fecal incontinence (FI) patients (10 male and 30 female, mean age 59 year) have been enrolled into the study; 20 pts (BF group) received 6 months standard (pressure and home EMG) biofeedback training. RF group (20 pts) – age, sex & FISI related - underwent radiofrequency anal sphincter remodeling (RASR). Outcome measures (studied 3, 6 and 12 m after treatment) included: diary, symptom questionnaire, FI severity index (FISI), disease specific life quality (FIQoL), and anorectal physiology (anorectal manometry, 48 channels s-EMG, barostat).
RESULT: Secca procedure yielded greater benefit to biofeedback in terms of all studied parameters. FI-SI decreased from 36,9 to 34,6- 30,8 in RF group (compared to 38,4 - 36,9 - 37,6 in BF group) ; FIQoL improved in RF group in all 4 studied parameters while in BF group in 2 of 4 respectively. Resting anal pressure increased significantly in RF group from 30,6 - 39,3 – 43,2,(mmHg)(3, 6, 12 m after) and insignificantly in BF (from 28,4 - 29,2 -30,4). Squeeze anal pressure in RF pts increased from 63,15 - 86,07- 96,3 (p,= 0,002); and from 70,4-74,8,- 68,8 (ns) in BF group. Rectal compliance decreased from 5,6 - 4,0 - 4,2 in RF group while in BF group remains unchanged. All studied s-EMG parameters increased in RF group after treatment as compared to preop. and to BF group.
CONCLUSION: Radiofrequency anal sphincter remodeling appeared more effective and stable than biofeedback method of FI treatment. RFASR significantly reduces frequency and severity of FI symptoms, improves patient‘s life quality and anorectal physiology parameters.
Does the Radiofrequency Procedure for Fecal Incontinence Improve Quality of Life and Incontinence at 1-Year Follow-Up?
Dan Ruiz, M.D., Rodrigo A. Pinto, M.D., Tracy L. Hull, M.D., Jonathan E. Efron, M.D., Steven D. Wexner, M.D. Dis Colon Rectum, July 2010; 53: 1041-1046
PURPOSE: Fecal incontinence is a socially isolating disease that causes physical and psychologic distress. Radiofrequency delivered to the anal canal is a surgical modality for fecal incontinence that has been noted to be safe and potentially effective. The aim of this study was to evaluate improvement in fecal incontinence and quality of life after the radiofrequency procedure at 1-year follow-up.
METHODS: After institutional review board approval, patients with fecal incontinence for at least 3 months were prospectively recruited between March 2003 and June 2004. Patients enrolled in the study underwent the Secca procedure. The Cleveland Clinic Florida Fecal Incontinence Score and the Fecal Incontinence Quality of Life Questionnaire were completed at the first visit and then at 12-month follow-up. Wilcoxon signed rank test was used to analyze the difference between baseline and follow-up.
RESULTS: A total of 24 patients (23 females) were enrolled in the study, and 16 were available at the 12-month follow-up visit. The main causes of fecal incontinence were either idiopathic or included obstetric injury, aging, and trauma from previous anorectal surgeries. The mean operative time was 45.5 + 8.3 minutes, and the mean number of radiofrequency lesions in the anal canal was 65.5 + 13.8. There were 3 self-limited episodes of postoperative bleedign and 1 instance of constipation that was resolved with laxatives. There were no delayed complications. The mean Cleveland Clinic Florida Fecal Incontinence Score improved from a mean of 15.6 (+ 3.2) at baseline to 12.9 (+ 4.6) at 12 months (P=.035). The mean Fecal Incontinence Quality of Life Questionnaire score improved in all subsets except for the depression score.
CONCLUSION: Radiofrequency is a safe, minimally invasive tool for treating patients with fecal incontinence. Improvement in fecal incontinence and quality of life was maintained at 12 months without delayed morbidity. The actual significance of this improvement is yet to be determined.
Radiofrequency waves in the treatment of faecal incontinence.
Piotr Walega, Katarzyna jasko, jakub Kenig, Roman Maria Herman, Wojciech Nowak. Proktologia 2009, 10 (2), p. 134-143
PURPOSE: In the therapeutic strategy of faecal incontinence (FI), the first-line recommended treatment is conservative, eventually combined with instrumental biofeedback and electrostimulation. Certainly, this does not concern postpaerperal injuries, where sphincter repair should be performed within the next 48 hours. If conservative measures prove ineffective, second-line surgical methods are implemented as "last resort" measures. The Secca procedure, or remodeling of muscle mass using radiofrequency waves is a technique, which might fill the gap between the two extremes of behavioural treatment and invasive surgery. The aim of this paper was to present the method and own preliminary results obtained therewith.
MATERIAL AND METHOD: Clinical material consisted of 20 patients with clinical and manometric signs of FI, where loss of sphincter muscle mass did not exceed 1/3 of anal circumference. Based on subjective FI symptoms assessed using the Jorge-Wexner and the FISI scales, severity of FI was evaluated. Quality of life was assessed using the FIQL questionnaire. All patients underwent a manometric study, including basal anal pressure (BAP), maximal squeeze anal pressure (SAP) and high pressure zone length (HPZL). The presence of rectoanal inhibitory reflex (RAIR) and rectal sphincter contraction on cough (RSCC) were ascertained. Surgical procedure was performed according to the procedure described by Takahashi et al. In this study we assessed duration of the procedure and intra- and postoperative complications. Follow-up visits took place 3 and 6 months after surgery.
RESULTS: Mean duration of procedure was 34 minutes, mean number of levels of successful application – 16, and total number of applications – 64. Mean hospital stay was 1.5 days. No intra- and direct postoperative complications were noticed during postoperative follow-up, 3 patients developed complications, which did not require surgical intervention. Degree of defecation control assessed by the Jorge-Wexner scale improved significantly. Except for 1 patient whose condition did not change, overall FISI score improved in a visible but not statistically significant way. Six months after surgery, a clear improvement of quality of life as compared to the preoperative status in all FIQL components (Lifestyle, Coping, Depression, Embarrassment). A significant increase of BAP and SAP was noticed after 6 months. Length of high pressure zone increased significantly throughout the entire follow-up. Prior to surgery, none of the patients presented normal rectoanal reflexes. After surgery, a gradual return and normalization of RAIR was observed 6 months after Secca procedure. RAIR was still absent in 6 patients and a paradoxical RAIR in the remaining.
CONCLUSION: Secca procedure significantly improves degree of defecation control and quality of life in patients with FI. It may be safely performed by an adequately experienced team. Encountered complications did not compromise subsequent treatment of patients.
Temperature-controlled radio frequency energy delivery (Secca® procedure) for the treatment of fecal incontinence: results of a prospective study
B. Lefebure & J. J. Tuech & V. Bridoux & S. Gallas & A. M. Leroi & P. Denis & F. Michot. Int J Colorectal Dis (2008) 23:993–997
PURPOSE: Fecal incontinence (FI) is a debilitating condition that can be socially and personally incapacitating. A broad range of treatment options, often stepwise, are available, depending on severity. This prospective study reports a large single-centered series of patients who have benefited of temperature-controlled radio frequency (Secca) energy delivered to the anal canal.
MATERIAL AND METHODS: This investigation was a singlecenter, nonrandomized, prospective, clinical study of a single patient group with each serving as the control. All patients had experienced FI for at least 3 months and had attempted, but were not satisfied, with the results of medical and/or surgical therapies. The study aims to evaluate changes in FI symptom scores and quality of life between the baseline and follow-up intervals.
RESULTS: Between March 2005 and March 2006, 15 Secca procedures were performed. All 15 patients were alive and in contact with the investigational site at time of 12 months. There were no long term complications. The mean Wexner score improved from 14.07 (±4.5) at baseline to 12.33 (±4.6) at 1 year (p=0.02). The mean fecal incontinence quality of life of life score was only improved in the depression subscore. There were no changes in endoanal ultrasound and anorectal manometry.
CONCLUSION: This prospective trial confirmed the safety of the Secca procedure. Although we demonstrated a significant improvement in the Wexner Score, these clinical results have to be mitigated because most patients remained in the moderate incontinences category as defined by the scoring system and did not improved their quality of life excepted in the depression subscore.
SECCA Procedure for the Treatment of Fecal Incontinence: Results of a Five-Year Follow-Up.
Takahashi-Monroy T, Morales M, Garcia-Osogobio S, Valdovinos MA, Belmonte C, Barreto C, Zarate X, Bada O, Velasco L. Service of Colon and Rectal Surgery, Department of Surgery, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico, DF, Mexico. Dis Colon Rectum. 2008 Mar;51(3):355-9. Epub 2008 Jan 19.
PURPOSE: This study evaluated the long-term (5-year) durability of radiofrequency energy delivery for fecal incontinence.
METHODS: This was an extension of the follow-up from our original prospective study in which patients who suffered from fecal incontinence were treated with the SECCA system for radiofrequency energy delivery to the anal canal muscle. The Cleveland Clinic Florida Fecal Incontinence Scale (0-20), fecal incontinence-related quality of life score, and Medical Outcomes Study Short-Form 36 were administered to five years. Differences between baseline and follow-up were analyzed by using paired t-test. RESULTS: A total of 19 patients were treated and followed for five years, including 18 females (aged 57.1 (range, 44-77) years). The mean duration for fecal incontinence was 7.1 (range, 1-21) years. At five-year follow-up, the mean fecal incontinence score had improved from 14.37 to 8.26 (P<0.00025) with 16 patients (84.2 percent) demonstrating >50 percent improvement. All fecal incontinence-related quality of life scores improved, including lifestyle (2.43 to 3.15; P<0.00075), coping (1.73 to 2.6; P<0.00083), depression (2.24 to 3.15; P<0.0002), and embarrassment (1.56 to 2.51; P<0.0003). The social function component of the Short-Form 36 improved from 38.3 to 60 (P<0.05). There was a trend toward improvement in the mental component summary of the Short-Form 36 from 38.1 to 48.14. There were no long-term complications.
CONCLUSIONS: Significant and sustained improvements in fecal incontinence symptoms and quality of life are seen at five years after treatment with the SECCA system. This treatment should be considered for patients suffering from fecal incontinence not amenable to surgery and who have failed conservative management.
Radiofrequency energy delivery, using the Secca device, into the anal canal muscle is a new modality that, in this study has safely provided five-year improvement in Wexner, FIQL scores and patient quality of life on an outpatient basis. Although not all patients improve, the majority can expect significant clinical response with minimal risk. Furthermore, there are no "bridges burned" by providing the Secca early in the treatment spectrum for patients suffering from fecal incontinence.
Temperature controlled radiofrequency energy (Secca®) to the anal canal for the treatment of fecal incontinence: pilot seems promising.
R. F. Felt-bersma; C. J. Mulder; Gastroenterology, VU University Medical centre, Amsterdam, Netherlands. Presented at DDW 2006
INTRODUCTION: Fecal incontinence is a devastating complaint. Even after conservative measures like diet adaptation, fibers and physiotherapy amajority of patients still has complaints. Few patients have a sphincter defect suitable for repair. Other emerging therapies like dynamic gracilis plasty or neuromodulation carry side effects and are not generally available partly due to financial restrictions. Temperature controlled radio frequency energy (RF), (Secca®) (equivalent to Stretta® of the esophagus) has shown promising results in the USA. The mode of action is not totally clear, local fibrosis seems the mode of action with possibly increased rectal sensitivity.
PATIENTS ANS METHODS: We treated 11 females, mean age 61 years (49-73) with the Secca® procedure. Patients with diarrhea (defecation more than 3 x day), sphincter defects and relative anal stenosis were excluded. The procedure was performed under conscious sedation and local anesthesia. Oral antibiotics were given 8 hours before, at the procedure and 8 hours later. In 4 quadrants on 4 or 5 levels (depending upon length of the anus) RF was delivered with multiple needle electrodes. Laxatives were prescribed in case of hard stools first days after treatment. Patients were evaluated at 0, 6 weeks, 3 and 6 months. Anal endosonography was performed at 0 (before and after the procedure), after 6 weeks and 3 months. Anal manometry and rectal compliance measurement were performed at 0 and 3 months.
RESULTS: At 3 months, 6 of 11 patients had an improvement (5 good, one slightly) and 5 none. The improvement persisted during follow up (6-9 months). At 3 months, the Vaizey score changed from 19 to 15 (p=0.056) and in the improved patients from 18,3 to 11,5 (p<0.001). The tests showed no change, there was a tendency of increased rectal sensitivity. Side effects were local hematoma (2), bleeding 3 days (1), pain persisting 2-3 weeks (4) and laxatives related diarrhea during 1-3 weeks (4). In conclusion, the Secca® procedure seems promising for patients with fecal incontinence with a persisting effect (so far follow up 6-9 months). Mild side effects are dominating the first 3 weeks, effect should be judged after 12 weeks. Financial reimbursing needs to be solved.
The Secca Procedure for the Treatment of Fecal Incontinence: Definitive Therapy or Short-Term Solution*
Christine J. Parisien, M.D. and Marvin L. Corman, M.D. Clinics in Colon and Rectal Surgery, volume 18, number 1, 2005.
The treatment of fecal incontinence by means of radiofrequency energy is based on the concept that collagen deposition and subsequent scarring may increase one’s ability to recognize and retain stool and permit improved continence. The procedure is undertaken on an outpatient basis. Individuals may be considered candidates even if they have a potentially reparable defect since the technique does not limit one to the application of a subsequent procedure. Clearly, those for whom other treatment methods have failed and those who have no other reasonable option in the management of their fecal incontinence should be considered for this procedure. Preliminary results are quite encouraging, and the results of a prospective, sham-controlled, randomized clinical trial are awaited.
A five-center study, in which the senior author participated, involved 50 patients (43 women) with fecal incontinence, all of whom were failures of medical or surgical management.7 Inclusion criteria included incontinence for stool as least once per week for 3 months. At baseline and at 6 months, the patients completed CCF-FI and the FIQL questionnaires as well as a social function questionnaire (SF-36). All subjects underwent anorectal manometry, pudendal nerve terminal motor latency, and anorectal ultrasound testing at baseline and 6 months. At 6 months, the mean CCF-FI score had improved from 14.5 to 11.1 (p<0.0001). All parameters in the FIQL were improved (p<0.001). There was an overall statistically significant improvement in the days with fecal incontinence, the days with gas incontinence, the incidence of pad soiling, the days with urgency, and the days with fear of fecal incontinence. With the exception of one center’s data, no objective changes were noted in physiologic studies with the exception that resting anal sphincter length increased by 25% (p1/40.019). Complications included mucosal ulceration (one superficial, one with underlying muscle injury) and delayed bleeding (one).
COMMENT: There is certainly a gap between nonoperative treatment of fecal incontinence and that of surgery. The Secca procedure is intended to offer a less-invasive option for the management of anal incontinence as compared with surgical alternatives. The Secca System received clearance from the US Food and Drug Administration in early 2002 for the treatment of fecal incontinence. While it is no longer considered an investigational approach there is a unique study currently being undertaken—that of a prospective, randomized, sham-controlled United States trial, in which the Secca procedure is compared with a placebo, anoscopic treatment. This is the only clinical trial of its kind that will meaningfully assess the outcome of any of the interventional options for the treatment of fecal incontinence. Regarding the Seccaprocedure and the currently available results, there is a favorable risk/benefit ratio when compared with alternative treatments. The Secca procedure is a minimally invasive, ambulatory procedure, and patients may return to normal activities within 48 hours. With respect to individuals who are potential candidates, it could be considered as first-line therapy for those with fecal incontinence, since "no bridges are burned." That is not to say that someone with a reparable sphincter defect would be better served by RF treatment, simply that it is believed that this approach would not preclude a subsequent operation. It should also be considered following a procedure or a treatment that has had less than satisfactory results or in someone who cannot tolerate an operation. Finally, it may certainly be offered as a ‘‘last resort’’ to a patient for whom there is no alternative except fecal diversion. While progress has been made in the areas of requisite training and case of use, a clearer treatment algorithm for the management of fecal incontinence is still required.
The SECCA Procedure: A New Therapy for Treatment of Fecal Incontinence.
Efron JE, M.D., F.A.C.S., F.A.S.C.R.S. The SECCA Procedure: A New Therapy for Treatment of Fecal Incontinence. Surg Tech Intl XIII December 2004;107-110.
CONCLUSION: The Secca device has been approved by the Federal Drug Administration (FDA) for the use in the United States (US). Many centers in the U.S. have started performing the procedure off protocol. Currently, a randomized, multi-center, single-blinded study is being completed in the U.S. to rule out the placebo effect as a cause for the improvement seen in prior trials. The available data, however, suggests the Secca procedure is effective in improving continence in many patients with minimal risk.
The Secca procedure may offer a bridging technique for patients who do not respond to medical therapy or biofeedback, are not candidates for sphincter repair, and who do not want to undergo the more invasive surgical procedures such as implantation of an artificial bowel sphincter. Performing the procedure does not preclude the patient from undergoing other more invasive procedures to help improve their continence if they do not respond well to the Secca procedure.
Safety and Effectiveness of Temperature-Controlled Radiofrequency Energy Delivery to the Anal Canal (Secca Procedure) for the Treatment of Fecal Incontinence.
Efron JE, Corman ML, Fleshman J, Barnett J, Nagle D, Birnbaum E, Weiss EG, Nogueras JJ, Sligh S, Rabine J, Wexner SD. Dis Colon Rectum. 2003 Dec;46(12):1606-16; discussion 1616-8.
PURPOSE: This multicenter study evaluated the safety and efficacy of radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence.
METHODS: Fifty patients at five centers were enrolled. All reported fecal incontinence at least once per week for three months, and medical and/or surgical management failed to help their symptoms. At baseline and six months, patients completed questionnaires (Cleveland Clinic Florida Fecal Incontinence score [0-20], fecal incontinence-related quality of life, Short Form-36, and visual analog scale) and underwent anorectal manometry, endoanal untrasound, and pudendal nerve terminal motor latency testing. On an outpatient basis using local anesthesia, radio-frequency energy was delivered via an anoscopic device with multiple needle electrodes (Secca® system) to create thermal lesions deep to the mucosa of the anal canal.
RESULTS: Forty-three females and seven males (aged 61.1 + 13.4 (mean + standard deviation); range 30-80 years) were treated. Mean duration of fecal incontinence was 14.9 years. Treatment time was 37 + 9 minutes. At six months, the mean Cleveland Clinic Florida Fecal Incontinence score improved from 14.5 to 11.1 (P<0.0001). All parameters in the Fecal Incontinence Quality of Life scales were improved (lifestyle (from 2.5-3.1; P<0.0001); coping (from 1.9-2.4; P<0.0001), depression (from 2.8-3.3; P=0.0004); embarrassment (from 1.9-2.5; P<0.0001)). Responders, as assessed by a systematic referenced analog scale, reported a median 70 percent resolution of symptoms. The mean Short Form-36 social function improved from 64.3 to 76 (P+0.003). There were no changes in endoanal ultrasound or pudendal nerve terminal motor latency assessment, or in anal manometry. Complications included mucosal ulceration (one superficial, on with underlying muscle injury) and delayed bleeding (n=1).
CONCLUSION: This multicenter trial demonstrates that radio-frequency energy can be safely delivered to the lower rectum and anal canal. The Secca® procedure significantly improved the Cleveland Clinic Florida Fecal Incontinence score and the overall quality of life for most patients having undergone the procedure.
Extended Two-Year Results of Radio-Frequency Energy Delivery for the Treatment of Fecal Incontinence (the Secca Procedure)
Takahashi T., Garcia-Osogobio S, Valdovinos M, Belmonte C, Barreto C, Velasco A. Extended Two-Year Results of Radio-Frequency Energy Delivery for the Treatment of Fecal Incontinence (the Secca Procedure). Dis Colon Rectum 2003;46:711-715.
PURPOSE: This study evaluated the durability and long-term safety of radio-frequency energy delivery for fecal incontinence (Secca procedure). METHODS: This was an extended follow-up of a prospective study in which patients with fecal incontinence of various causes underwent radio-frequency energy delivery to the anal canal muscle. The Cleveland Clinic Florida Fecal Incontinence Scale (0–20), fecal incontinence–related quality-of-life score, and Medical Outcomes Study Short Form 36 were administered at baseline and at 1, 2, 3, 6, 12, and 24 months after the procedure. Differences between baseline and follow-up were analyzed with the Wilcoxon signed-rank test.
RESULTS: Ten females (aged 55.9 + 9.2 (range, 44–74) years) were treated. At two-year follow-up, the mean Cleveland Clinic Florida Fecal Incontinence Scale score was improved from 13.8 to 7.3 (P < 0.002), with eight patients having scores of <10. All fecal incontinence–related quality-of-life score parameters were improved, including lifestyle (from 2.3 to 3.3; P < 0.002), coping (from 1.7 to 2.7; P < 0.002), depression (from 2.4 to 3.4; P < 0.004), and embarrassment (from 1.5 to 2.4; P < 0.008). There was no decrement in effect noted in any parameter between 12 and 24 months (P < 0.2). The social function component of the Short Form 36 improved from 50 to 82.5 (P < 0.04), whereas there was an improvement trend for the mental component summary of the Short Form 36 from 38.3 to 48.1 (P < 0.11). Protective pad use was eliminated in four of the seven baseline users. There were no long-term complications, such as stricture, pain, or constipation.
CONCLUSIONS: A significant improvement in symptoms of fecal incontinence and quality of life persists two years after radio-frequency delivery to the anal canal, which demonstrates durability of this intervention.
Radiofrequency Energy Delivery to the Anal Canal for the Treatment of Fecal Incontinence.
Takahashi T, Garcia-Osogobio S, Valdovinos MA, Mass W, Jimenez R, Jauregui AL, Bobadilla J, Belmonte C, Edelstein PS, Utley DS. Radiofrequency Energy Delivery to the Anal Canal for the Treatment of Fecal Incontinence. Dis Colon Rectum 2002;45:915-922.
PURPOSE: In this prospective study we investigated the feasibility, safety, and efficacy of radio-frequency energy delivery deep to the mucosa of the anal canal for the treatment of fecal incontinence. METHODS: We studied ten patients with fecal incontinence of varying causes. All patients underwent anoscopy, anorectal manometry, endorectal ultrasound, and pudendal nerve terminal motor latency testing at baseline and six months. The Cleveland Clinic Florida scale for fecal incontinence (Wexner, 0–20), fecal incontinence-related quality of life score, and Short Form 36 were administered at baseline, 1, 2, 3, 6, and 12 months. Using conscious sedation and local anesthesia, we delivered temperature-controlled radio-frequency energy via an anoscopic device with multiple needle electrodes to create thermal lesions deep to the mucosa of the anal canal.
RESULTS: Ten females (age, 55.9 + 9.2 years; range, 44–74) were enrolled and treated. Median discomfort by visual analog scale (0–10) was 3.8 during and 0.9 two hours after the procedure. Bleeding occurred in four patients (14–21 days after procedure), spontaneous resolution (n = 3) and anoscopic suture ligation (n = 1). At 12 months, the median Wexner score improved from 13.5 to 5 (P < 0.001), with 80 percent of patients considered responders. All parameters in the fecal incontinence-related quality of life were improved (lifestyle (from 2.3 to 3.4), coping (from 1.4 to 2.7), depression (from 2.2 to 3.5), and embarrassment (from 1.3 to 2.8); P < 0.05 for all parameters). Protective pad use was eliminated in five of the seven baseline users. At six months, there was a significant reduction in both initial and maximum tolerable rectal distention volumes. Anoscopy was normal at six months.
CONCLUSION: Radio-frequency energy delivery to the anal canal for treatment of fecal incontinence is a new modality that, in this study group, safely improved Wexner and fecal incontinence-related quality of life scores, eliminated protective pad use in most patients, and improved patient quality of life.