Long-term Efficacy of Percutaneous Tibial Nerve Stimulation Applied to Patients With Faecal Incontinence.

NCT ID: NCT05016453

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 139 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-08
• Study Completion Date: 2021-04-24

Brief Summary

Percutaneous tibial nerve stimulation (PTNS) is an ambulatory therapy validated for patients with Faecal Incontinence (FI) refractory to conservative treatment with proved short and mid-term efficacy.

The investigators therefore aimed to evaluate the long-term efficacy of PTNS, considered 3 years of follow-up. The investigators also aimed to identify predictors of responses and suggest a new approach for partial responders.

Detailed Description

Prospective single-centre cohort of patients with FI treated with PTNS was analysed.

PTNS sessions were performed in three phases: weekly for three months in the first phase, biweekly for three months in the second phase, and monthly for six months in the third and final phase.

Clinical control at the end of each phase and an additional follow-up was performed at 36 months. Wexner score, faecal urgency, bowel habits and quality of life for FI were assessed.

Patients were categorized in three groups: optimal responders when there was an improvement in Wexner score > 50%; partial responders if the improvement in Wexner score was 25-50%; and non-responders, when the improvement of Wexner score was < 25%.

Optimal responders and partial responders progressed into successive phases, whereas non-responders abandoned PTNS and other treatment options were offered.

Conditions

Faecal Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of faecal incontinence for more than 6 months, refractory to conservative treatment.

Exclusion Criteria

• Anatomic injuries that require surgery.
• External anal sphincter lesion of > 180º.
• Unavailability to attend regularly outpatient clinic.
• Major psychologic or psychiatric comorbidities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

OTHER

Sponsor Role: lead

Responsible Party

Luis Sánchez Guillen

Clinical Professor Luis Sánchez-Guillén

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital General Universitario de Elche

Elche, Alicante, Spain

Countries

Spain

References

Macmillan AK, Merrie AE, Marshall RJ, Parry BR. The prevalence of fecal incontinence in community-dwelling adults: a systematic review of the literature. Dis Colon Rectum. 2004 Aug;47(8):1341-9. doi: 10.1007/s10350-004-0593-0.

Reference Type: BACKGROUND

PMID: 15484348 (View on PubMed)

Maestre Y, Pares D, Vial M, Bohle B, Sala M, Grande L. [Prevalence of fecal incontinence and its relationship with bowel habit in patients attended in primary care]. Med Clin (Barc). 2010 Jun 12;135(2):59-62. doi: 10.1016/j.medcli.2010.01.031. Epub 2010 Apr 22. Spanish.

Reference Type: BACKGROUND

PMID: 20416902 (View on PubMed)

MacLennan AH, Taylor AW, Wilson DH, Wilson D. The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery. BJOG. 2000 Dec;107(12):1460-70. doi: 10.1111/j.1471-0528.2000.tb11669.x.

Reference Type: BACKGROUND

PMID: 11192101 (View on PubMed)

Johanson JF, Lafferty J. Epidemiology of fecal incontinence: the silent affliction. Am J Gastroenterol. 1996 Jan;91(1):33-6.

Reference Type: BACKGROUND

PMID: 8561140 (View on PubMed)

Madoff RD. Surgical treatment options for fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S48-54. doi: 10.1053/j.gastro.2003.10.015.

Reference Type: BACKGROUND

PMID: 14978638 (View on PubMed)

Jarrett ME, Mowatt G, Glazener CM, Fraser C, Nicholls RJ, Grant AM, Kamm MA. Systematic review of sacral nerve stimulation for faecal incontinence and constipation. Br J Surg. 2004 Dec;91(12):1559-69. doi: 10.1002/bjs.4796.

Reference Type: BACKGROUND

PMID: 15455360 (View on PubMed)

Thin NN, Horrocks EJ, Hotouras A, Palit S, Thaha MA, Chan CL, Matzel KE, Knowles CH. Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence. Br J Surg. 2013 Oct;100(11):1430-47. doi: 10.1002/bjs.9226.

Reference Type: BACKGROUND

PMID: 24037562 (View on PubMed)

Gupta P, Ehlert MJ, Sirls LT, Peters KM. Percutaneous tibial nerve stimulation and sacral neuromodulation: an update. Curr Urol Rep. 2015 Feb;16(2):4. doi: 10.1007/s11934-014-0479-1.

Reference Type: BACKGROUND

PMID: 25630918 (View on PubMed)

Hidalgo-Pujol M, Andriola V, Jimenez-Gomez LM, Ostiz F, Espin E. Medium-term outcome of percutaneous tibial nerve stimulation in the treatment of fecal incontinence. Tech Coloproctol. 2018 Nov;22(11):875-879. doi: 10.1007/s10151-018-1892-0. Epub 2018 Dec 18.

Reference Type: BACKGROUND

PMID: 30565161 (View on PubMed)

Hotouras A, Ribas Y, Allison M, Murphy J. The CONFIDeNT trial. Lancet. 2016 Feb 13;387(10019):643-644. doi: 10.1016/S0140-6736(16)00281-6. No abstract available.

Reference Type: BACKGROUND

PMID: 26876707 (View on PubMed)

de la Portilla F, Laporte M, Maestre MV, Diaz-Pavon JM, Gollonet JL, Palacios C, Vazquez-Monchul JM, Garcia-Cabrera AM, Jimenez-Rodriguez RM, Sanchez Gil JM. Percutaneous neuromodulation of the posterior tibial nerve for the treatment of faecal incontinence - mid-term results: is retreatment required? Colorectal Dis. 2014 Apr;16(4):304-10. doi: 10.1111/codi.12539.

Reference Type: BACKGROUND

PMID: 24617790 (View on PubMed)

Hotouras A, Murphy J, Walsh U, Allison M, Curry A, Williams NS, Knowles C, Chan CL. Outcome of percutaneous tibial nerve stimulation (PTNS) for fecal incontinence: a prospective cohort study. Ann Surg. 2014 May;259(5):939-43. doi: 10.1097/SLA.0b013e3182a6266c.

Reference Type: BACKGROUND

PMID: 23979291 (View on PubMed)

Munoz-Duyos A, Lagares-Tena L, Vargas-Pierolas H, Rodon A, Navarro-Luna A. High-resolution circuit for the diagnosis of faecal incontinence. Patient satisfaction. Cir Esp. 2017 May;95(5):276-282. doi: 10.1016/j.ciresp.2017.04.012. Epub 2017 Jun 8. English, Spanish.

Reference Type: BACKGROUND

PMID: 28602392 (View on PubMed)

Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.

Reference Type: BACKGROUND

PMID: 10813117 (View on PubMed)

Hotouras A, Thaha MA, Allison ME, Currie A, Scott SM, Chan CL. Percutaneous tibial nerve stimulation (PTNS) in females with faecal incontinence: the impact of sphincter morphology and rectal sensation on the clinical outcome. Int J Colorectal Dis. 2012 Jul;27(7):927-30. doi: 10.1007/s00384-011-1405-3. Epub 2012 Jan 25.

Reference Type: BACKGROUND

PMID: 22274577 (View on PubMed)

Lemon SC, Roy J, Clark MA, Friedmann PD, Rakowski W. Classification and regression tree analysis in public health: methodological review and comparison with logistic regression. Ann Behav Med. 2003 Dec;26(3):172-81. doi: 10.1207/S15324796ABM2603_02.

Reference Type: BACKGROUND

PMID: 14644693 (View on PubMed)

Shafik A, Ahmed I, El-Sibai O, Mostafa RM. Percutaneous peripheral neuromodulation in the treatment of fecal incontinence. Eur Surg Res. 2003 Mar-Apr;35(2):103-7. doi: 10.1159/000069399.

Reference Type: BACKGROUND

PMID: 12679620 (View on PubMed)

Queralto M, Portier G, Cabarrot PH, Bonnaud G, Chotard JP, Nadrigny M, Lazorthes F. Preliminary results of peripheral transcutaneous neuromodulation in the treatment of idiopathic fecal incontinence. Int J Colorectal Dis. 2006 Oct;21(7):670-2. doi: 10.1007/s00384-005-0068-3. Epub 2005 Dec 6.

Reference Type: BACKGROUND

PMID: 16331464 (View on PubMed)

Govaert B, Pares D, Delgado-Aros S, La Torre F, Van Gemert WG, Baeten CG. A prospective multicentre study to investigate percutaneous tibial nerve stimulation for the treatment of faecal incontinence. Colorectal Dis. 2010 Dec;12(12):1236-41. doi: 10.1111/j.1463-1318.2009.02020.x.

Reference Type: BACKGROUND

PMID: 19674028 (View on PubMed)

Thomas GP, Dudding TC, Bradshaw E, Nicholls RJ, Vaizey CJ. A pilot study to compare daily with twice weekly transcutaneous posterior tibial nerve stimulation for faecal incontinence. Colorectal Dis. 2013 Dec;15(12):1504-9. doi: 10.1111/codi.12428.

Reference Type: BACKGROUND

PMID: 24118972 (View on PubMed)

Arroyo Fernandez R, Avendano Coy J, Ando Lafuente S, Martin Correa M feminineT, Ferri Morales A. Posterior tibial nerve stimulation in the treatment of fecal incontinence: a systematic review. Rev Esp Enferm Dig. 2018 Sep;110(9):577-588. doi: 10.17235/reed.2018.5007/2017.

Reference Type: BACKGROUND

PMID: 30168339 (View on PubMed)

Pena Ros E, Parra Banos PA, Benavides Buleje JA, Munoz Camarena JM, Escamilla Segade C, Candel Arenas MF, Gonzalez Valverde FM, Albarracin Marin-Blazquez A. Short-term outcome of percutaneous posterior tibial nerve stimulation (PTNS) for the treatment of faecal incontinence. Tech Coloproctol. 2016 Jan;20(1):19-24. doi: 10.1007/s10151-015-1380-8.

Reference Type: BACKGROUND

PMID: 26499791 (View on PubMed)

Lopez-Delgado A, Arroyo A, Ruiz-Tovar J, Alcaide MJ, Diez M, Moya P, Santos J, Calpena R. Effect on anal pressure of percutaneous posterior tibial nerve stimulation for faecal incontinence. Colorectal Dis. 2014 Jul;16(7):533-7. doi: 10.1111/codi.12628.

Reference Type: BACKGROUND

PMID: 24674305 (View on PubMed)

Leroi AM, Siproudhis L, Etienney I, Damon H, Zerbib F, Amarenco G, Vitton V, Faucheron JL, Thomas C, Mion F, Roumeguere P, Gourcerol G, Bouvier M, Lallouche K, Menard JF, Queralto M. Transcutaneous electrical tibial nerve stimulation in the treatment of fecal incontinence: a randomized trial (CONSORT 1a). Am J Gastroenterol. 2012 Dec;107(12):1888-96. doi: 10.1038/ajg.2012.330. Epub 2012 Oct 2.

Reference Type: BACKGROUND

PMID: 23032981 (View on PubMed)

Other Identifiers

PTNSLONGTERMEFFICACY

Identifier Type: -

Identifier Source: org_study_id