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

NCT01780636 | Terminated Phase 2 Results DMC

• 1 other identifier: ALLERGAN-72570 HS# 2012-8750
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-relaxing Puborectalis Syndrome

Keywords

Non relaxing puborectalis syndrome; Botulinum toxin A; Botox; Constipation

Outcome Measures

Primary Outcomes (2)

• Change in Symptoms Based on Scores Using the PAC-SYM and Wexner Constipation Questionnaires.

  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.

  Baseline to 6 months post-injection

• PAC-SYM and Wexner Scores

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

  Baseline to 6 months

Secondary Outcomes (1)

• Change in Pressures on Anal Manometry

  Baseline to 6 months post-injection

Study Arms (1)

Botulinum toxin (Botox) injection

EXPERIMENTAL

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.

Drug: botulinum toxin

Interventions

botulinum toxin DRUG

Also known as: Botox (Allergan, Irvine, CA)

Botulinum toxin (Botox) injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years of age or older
• Diagnosis of non-relaxing puborectalis syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Karen Noblett: lead
• American Urogynecologic Society: collaborator
• Allergan: collaborator

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (15)

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

  PMID: 20011350 BACKGROUND

• 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.

  PMID: 14128302 BACKGROUND

• 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.

  PMID: 4053909 BACKGROUND

• 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.

  PMID: 9336109 BACKGROUND

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

  PMID: 447047 BACKGROUND

• 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.

  PMID: 2070237 BACKGROUND

• 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.

  PMID: 7956583 BACKGROUND

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

  PMID: 8003569 BACKGROUND

• 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.

  PMID: 11517060 BACKGROUND

• 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.

  PMID: 9244917 BACKGROUND

• 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.

  PMID: 18068787 BACKGROUND

• 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.

  PMID: 10733120 BACKGROUND

• 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.

  PMID: 17029615 BACKGROUND

• 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.

  PMID: 11742168 BACKGROUND

• 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.

  PMID: 9845612 BACKGROUND

Related Links

• American Urogynecologic Society

MeSH Terms

Conditions

Constipation

Interventions

Botulinum Toxins; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Karen Noblett
• Organization: UC Irvine

knoblett@uci.edu

714-456-6807

Study Officials

• Karen Noblett, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Obstetrics & Gynecology

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 31, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2021-10

Locations

US (1)