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Faecal IncontinencePTNSLONGNCT05016453

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

An observational study of Faecal Incontinence, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Faecal Incontinence
How many people
139 participants
Where
1 siteSpain
Study dates
8 Jan 2010to 24 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

Other trials in Spain

About this study

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

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.

Read the 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.

Keywords
percutaneous tibial nerve stimulation, anal physiology, faecal incontinence, partial response, long-term efficacy
Medical subject headings
Encopresis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline compared to 3, 6, 12 and 36 months after start of PTNS

Secondary outcomes (2)

  1. 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

    Measured: At 3, 6 and 12 months after start of PTNS

  2. 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

    Measured: At 3, 6 and12 months after start of PTNS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2021
  2. Study start8 Jan 2010
  3. Primary completion15 Jun 2017
  4. Study completion24 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05016453
Sponsor's protocol ID
PTNSLONGTERMEFFICACY
Acronym
PTNSLONG
Status last verified
Aug 2021
First submitted
6 Jul 2021
Last updated
23 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15484348

  • 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.

    PubMed 20416902

  • 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.

    PubMed 11192101

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

    PubMed 8561140

  • 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.

    PubMed 14978638

  • 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.

    PubMed 15455360

  • 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.

    PubMed 24037562

  • 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.

    PubMed 25630918

  • 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.

    PubMed 30565161

  • 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.

    PubMed 26876707

  • 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.

    PubMed 24617790

  • 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.

    PubMed 23979291

  • 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.

    PubMed 28602392

  • 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.

    PubMed 10813117

  • 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.

    PubMed 22274577

Questions about this trial

What is this clinical trial studying?

An observational study of Faecal Incontinence, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in faecal incontinence assessed by Wexner Score (time frame: Baseline compared to 3, 6, 12 and 36 months after start of PTNS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05016453, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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