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

NCT ID: NCT01780636

Last Updated: 2021-11-03

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-relaxing Puborectalis Syndrome

Keywords

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Non relaxing puborectalis syndrome Botulinum toxin A Botox Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Botulinum toxin (Botox) injection

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.

Group Type EXPERIMENTAL

botulinum toxin

Intervention Type DRUG

Interventions

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botulinum toxin

Intervention Type DRUG

Other Intervention Names

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Botox (Allergan, Irvine, CA)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karen Noblett

OTHER

Sponsor Role lead

American Urogynecologic Society

OTHER

Sponsor Role collaborator

Allergan

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Karen Noblett

Professor of Obstetrics & Gynecology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karen Noblett, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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University of California, Irvine Medical Center

Orange, California, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 20011350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14128302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4053909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9336109 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 447047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2070237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7956583 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8003569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11517060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9244917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18068787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10733120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17029615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11742168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9845612 (View on PubMed)

Related Links

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http://www.augs.org/

American Urogynecologic Society

Other Identifiers

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ALLERGAN-72570 HS# 2012-8750

Identifier Type: -

Identifier Source: org_study_id