Clinical trial NCT05016453: Long-term Efficacy of Percutaneous Tibial Nerve Stimulation Applied to Patients With Faecal Incontinence.
Official title: Long-term Efficacy of Percutaneous Tibial Nerve Stimulation for Faecal Incontinence and New Approach for Partial Responders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Faecal Incontinence
Keywords: percutaneous tibial nerve stimulation
anal physiology
faecal incontinence
partial response
long-term efficacy
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years old, diagnosed with faecal incontinence (at least one or more episodes of faecal incontinence for more than 6 months) refractory to conservative treatment.

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.

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

Primary outcomes:
measure: Change in faecal incontinence assessed by Wexner Score
timeFrame: Baseline compared to 3, 6, 12 and 36 months after start of PTNS
Secondary outcomes:
measure: Predictors of good long-term improvement in Wexner score
timeFrame: At 3, 6 and 12 months after start of PTNS
measure: Partial Responders
timeFrame: At 3, 6 and12 months after start of PTNS
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Johanson JF, Lafferty J. Epidemiology of fecal incontinence: the silent affliction. Am J Gastroenterol. 1996 Jan;91(1):33-6.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.