Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome

Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with non-relaxing puborectalis syndrome. With use of this technique, we believe we will find that Botox injections decrease symptom severity and improve quality of life (QOL) in patients with NRPS. All enrolled patients will receive ultrasound and EMG guided Botox injections at three points along the puborectalis muscle. Post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals.

Non-relaxing puborectalis syndrome (NRPS) is an obstructive defecatory disorder that presents with chronic constipation, anismus, or a sensation of incomplete rectal emptying. The specific etiology of this syndrome is unknown. The true incidence of NRPS is unknown, but it is estimated that 4% of patients with defecatory disorders have NRPS. Previous therapies for non-relaxing PRS have included biofeedback, pelvic floor physical therapy, dietary changes, laxatives, enemas, and surgical division of the puborectalis muscle. Unfortunately, responses to these treatments have been variable at best. Direct injection of botulinum toxin (Botox) into the puborectalis muscle is an alternative approach for treating NRPS and has recently been reported in a limited number of studies. Botox blocks cholinergic nerve endings in the autonomic nervous system and has been used to weaken the puborectalis muscle in constipated patients. Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with NRPS. With use of this technique, we believe we will find that Botox injections decrease symptom severity and improve quality of life (QOL) in patients with NRPS. We plan to compare patient reported symptoms, symptom severity, and QOL prior to Botox injections with symptoms and QOL at 2-week, 3-month, and 6-month intervals after Botox injection into the puborectalis muscle in patients with NRPS. All enrolled patients will receive ultrasound and EMG guided Botox injections at three points along the puborectalis muscle. Post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals. Additional injections will be offered to patients who fail the initial treatment.

All patients will be given the active Botox injection and thus this study will remain open-label and non-randomized as this is a pilot study to determine initial efficacy.

To assess whether Botox injections into the puborectalis muscle will improve patient's symptoms based on scores using the PAC-SYM and Wexner Constipation validated questionnaires from baseline to 6 months post-Botox injection to determine severity of symptoms. The PAC-SYM questionnaire unabbreviated title is Patient Assessment of Constipation-Symptoms and the total score is summed ranging from 0 to 44. The Wexner Constipation questionnaire total score is summed ranging from 0 to 30. Both questionnaires have higher values representing a worse outcome.

Scores on a scale The baseline scores were compared to scores at 6 months to evaluate the degree of improvement

To assess the change in pressures on anal manometry before and after Botox injections into the puborectalis muscle from baseline to 6 months post-Botox injection. Anal manometry is a test done in clinic to assess bowel function. Average resting pressure is recorded using the advanced diagnostic equipment. Above 40 mmHg is normal for resting pressure. Also, average squeeze pressure will be recorded. Greater than 100 mmHg is normal for average squeeze pressure.

Inclusion Criteria: Female 18 years of age or older Diagnosis of non-relaxing puborectalis syndrome Exclusion Criteria: Allergy or sensitivity to botulinum toxin Pregnancy or plan to become pregnant in the subsequent 6 months after injection Undiagnosed ano-rectal mass, lesion, or infection Stage II or greater rectocele

Times ML, Reickert CA. Functional anorectal disorders. Clin Colon Rectal Surg. 2005 May;18(2):109-15. doi: 10.1055/s-2005-870892.

WASSERMAN IF. PUBORECTALIS SYNDROME (RECTAL STENOSIS DUE TO ANORECTAL SPASM). Dis Colon Rectum. 1964 Mar-Apr;7:87-98. doi: 10.1007/BF02616902. No abstract available.

Kuijpers HC, Bleijenberg G. The spastic pelvic floor syndrome. A cause of constipation. Dis Colon Rectum. 1985 Sep;28(9):669-72. doi: 10.1007/BF02553449.

Karlbom U, Hallden M, Eeg-Olofsson KE, Pahlman L, Graf W. Results of biofeedback in constipated patients: a prospective study. Dis Colon Rectum. 1997 Oct;40(10):1149-55. doi: 10.1007/BF02055160.

Meunier P, Marechal JM, de Beaujeu MJ. Rectoanal pressures and rectal sensitivity studies in chronic childhood constipation. Gastroenterology. 1979 Aug;77(2):330-6.

MacDonald A, Shearer M, Paterson PJ, Finlay IG. Relationship between outlet obstruction constipation and obstructed urinary flow. Br J Surg. 1991 Jun;78(6):693-5. doi: 10.1002/bjs.1800780620.

Mellgren A, Bremmer S, Johansson C, Dolk A, Uden R, Ahlback SO, Holmstrom B. Defecography. Results of investigations in 2,816 patients. Dis Colon Rectum. 1994 Nov;37(11):1133-41. doi: 10.1007/BF02049817.

Wexner SD, Jorge JM. Colorectal physiological tests: use or abuse of technology? Eur J Surg. 1994 Mar;160(3):167-74.

Halligan S, Malouf A, Bartram CI, Marshall M, Hollings N, Kamm MA. Predictive value of impaired evacuation at proctography in diagnosing anismus. AJR Am J Roentgenol. 2001 Sep;177(3):633-6. doi: 10.2214/ajr.177.3.1770633.

Salzano A, Cavallo G, De Rosa A, De Luca LE, Serpe A, Losco M. [Diagnosis with defecography of puborectal muscle syndrome]. Radiol Med. 1997 Apr;93(4):396-400. Italian.

Ganeshan A, Anderson EM, Upponi S, Planner AC, Slater A, Moore N, D'Costa H, Bungay H. Imaging of obstructed defecation. Clin Radiol. 2008 Jan;63(1):18-26. doi: 10.1016/j.crad.2007.05.015. Epub 2007 Sep 14.

Maria G, Brisinda G, Bentivoglio AR, Cassetta E, Albanese A. Botulinum toxin in the treatment of outlet obstruction constipation caused by puborectalis syndrome. Dis Colon Rectum. 2000 Mar;43(3):376-80. doi: 10.1007/BF02258305.

Maria G, Cadeddu F, Brandara F, Marniga G, Brisinda G. Experience with type A botulinum toxin for treatment of outlet-type constipation. Am J Gastroenterol. 2006 Nov;101(11):2570-5. doi: 10.1111/j.1572-0241.2006.00791.x. Epub 2006 Oct 4.

Ron Y, Avni Y, Lukovetski A, Wardi J, Geva D, Birkenfeld S, Halpern Z. Botulinum toxin type-A in therapy of patients with anismus. Dis Colon Rectum. 2001 Dec;44(12):1821-6. doi: 10.1007/BF02234461.

Shafik A, El-Sibai O. Botulin toxin in the treatment of nonrelaxing puborectalis syndrome. Dig Surg. 1998;15(4):347-51. doi: 10.1159/000018630.