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

Faecal Incontinence Clinical Trial

— PTNSLONG  

Official title:

Long-term Efficacy of Percutaneous Tibial Nerve Stimulation for Faecal Incontinence and New Approach for Partial Responders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016453
• Other study ID #: PTNSLONGTERMEFFICACY
• Status: Completed
• Start date: January 8, 2010
• Est. completion date: April 24, 2021

Study information

• Verified date: August 2021
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: April 24, 2021
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Elche	Elche	Alicante

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (24)

Arroyo Fernández R, Avendaño Coy J, Ando Lafuente S, Martín Correa MªT, 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. — View Citation

de la Portilla F, Laporte M, Maestre MV, Díaz-Pavón JM, Gollonet JL, Palacios C, Vázquez-Monchul JM, García-Cabrera AM, Jiménez-Rodríguez RM, Sánchez 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Hotouras A, Ribas Y, Allison M, Murphy J. The CONFIDeNT trial. Lancet. 2016 Feb 13;387(10019):643-4. doi: 10.1016/S0140-6736(16)00281-6. — View 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. — View 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. Review. — View Citation

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

Leroi AM, Siproudhis L, Etienney I, Damon H, Zerbib F, Amarenco G, Vitton V, Faucheron JL, Thomas C, Mion F, Roumeguère 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. — View Citation

López-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. — View 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. — View 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. Review. — View Citation

Madoff RD. Surgical treatment options for fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S48-54. Review. — View Citation

Maestre Y, Parés 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. — View Citation

Muñoz-Duyos A, Lagares-Tena L, Vargas-Pierolas H, Rodón 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. — View Citation

Peña Ros E, Parra Baños PA, Benavides Buleje JA, Muñoz Camarena JM, Escamilla Segade C, Candel Arenas MF, Gonzalez Valverde FM, Albarracín Marín-Blázquez 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. — View 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. Epub 2005 Dec 6. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in faecal incontinence assessed by Wexner Score	Rate of patients with improvement in faecal incontinence assessed by Wexner score (Maximum punctuation: 20 being severe incontinence. Minimum punctuation: 0, no incontinence).	Baseline compared to 3, 6, 12 and 36 months after start of PTNS
Secondary	Predictors of good long-term improvement in Wexner score	Influence of previous obstetric or surgery history and duration of symptoms in the variation of Wexner score	At 3, 6 and 12 months after start of PTNS
Secondary	Partial Responders	Incidence of patients with a decrease in Wexner score between 25 and 50% compared to initial value, and their performance in the long term	At 3, 6 and12 months after start of PTNS