Optimising Treatments for Faecal Incontinence

NCT04273009 | Completed

• 1 other identifier: 16/LO/1821
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to directly compare two medical treatments for faecal incontinence: Renew™ Anal Insert and Percutaneous Tibial Nerve Stimulation (PTNS) for a period of 12 weeks. Both are routinely used in our practice.

Conditions

Faecal Incontinence; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• Renew vs PTNS treatment

  A consecutive two weeks bowel diaries at 3 months follow up Use of PTNS or RENEW Frequency of episodes of faecal incontinence

  3 months

Secondary Outcomes (2)

• Pain

  3 months

• Severity of incontinence

  3 months

Study Arms (2)

Renew Anal Insert

ACTIVE COMPARATOR

The device is intended for self-insertion through the anal canal aided by a fingertip applicator.

Device: Renew VS PTNS

Percutaneous tibial nerve stimulation

ACTIVE COMPARATOR

A fine needle is inserted next to the tibial nerve above the ankle, a ground pad is attached to the heel and electric current just strong enough to cause minor tingling is passed between these two points.

Device: Renew VS PTNS

Interventions

Renew VS PTNS DEVICE

These will be prescribed and applied as described above.

Percutaneous tibial nerve stimulation; Renew Anal Insert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Passive or mixed faecal incontinence.
• Minimum two or more episodes of faecal incontinence per week as assessed by prospectively collected bowel diaries.
• Failed biofeedback, pelvic floor physiotherapy or other medical management.
• Able to self- administer the Renew™ Anal Insert.
• Competent and willing to fill in questionnaires and attend clinics throughout the study.
• Patient must be able to comprehend and informed consent prior to enrolment in the study.

You may not qualify if:

• Pregnancy.
• Inability to given informed consent.
• Perianal sepsis.
• Rectal bleeding.
• Inflammatory bowel disease/ Proctitis.
• Rectal prolapse.
• Third or fourth-degree hemorrhoids.
• Anal stricture.
• Anal or Recto-vaginal fistula.
• Rectal surgery in the past 3 months.
• Known allergy to Silicone.
• Patients who are mentally or physically unable to comply with the protocol of the study.
• The presence of any other medical condition which, in the opinion of the Chief Investigator, deems the patient unsuitable for participation in the study.

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Related Publications (5)

• Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.

  PMID: 8416784 BACKGROUND

• Norton C, Kamm MA. Anal plug for faecal incontinence. Colorectal Dis. 2001 Sep;3(5):323-7. doi: 10.1046/j.1463-1318.2001.00257.x.

  PMID: 12790954 BACKGROUND

• Horrocks EJ, Chadi SA, Stevens NJ, Wexner SD, Knowles CH. Factors Associated With Efficacy of Percutaneous Tibial Nerve Stimulation for Fecal Incontinence, Based on Post-Hoc Analysis of Data From a Randomized Trial. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1915-1921.e2. doi: 10.1016/j.cgh.2017.06.032. Epub 2017 Jun 21.

  PMID: 28647458 BACKGROUND

• Segal JP, Leo CA, Hodgkinson JD, Cavazzoni E, Bradshaw E, Lung PFC, Ilangovan R, Vaizey CJ, Faiz OD, Hart AL, Clark SK. Acceptability, effectiveness and safety of a Renew(R) anal insert in patients who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis. Colorectal Dis. 2019 Jan;21(1):73-78. doi: 10.1111/codi.14422. Epub 2018 Oct 8.

  PMID: 30218632 BACKGROUND

• Leo CA, Thomas GP, Hodgkinson JD, Leeuwenburgh M, Bradshaw E, Warusavitarne J, Murphy J, Vaizey CJ. Randomized Pilot Study: Anal Inserts Versus Percutaneous Tibial Nerve Stimulation in Patients With Fecal Incontinence. Dis Colon Rectum. 2021 Apr 1;64(4):466-474. doi: 10.1097/DCR.0000000000001913.

  PMID: 33399411 DERIVED

MeSH Terms

Conditions

Encopresis; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and first investigator will be masked from the actual treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who have completed the treatment can switch to the other treatment offered.

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 17, 2020
• Study Start: December 15, 2016
• Primary Completion: August 11, 2018
• Study Completion: September 11, 2018
• Last Updated: February 17, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share