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CompletedNCT05464589Updated Apr 24, 2023

Effects of Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Adults

An interventional study of Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening and Pelvic floor muscles strengthening in Overactive Bladder, Urge Incontinence and Nocturia, sponsored by Dow University of Health Sciences. Completed at 3 sites in Pakistan. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-24.

Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Aug 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study summary

For overactive bladder symptoms, there are numerous physiotherapy techniques have been found to be beneficial. Transcutaneous electrical stimulation of the tibial nerve is one of those treatment options, that is entirely a non-invasive, easy to apply, and cost-effective technique.

Transcutaneous stimulation of the tibial nerve targets the sacral nerve plexus that contracts the pelvic floor muscles and controls the bladder function.

This research aims to study the effectiveness of transcutaneous tibial nerve stimulation in adults with overactive bladder symptoms along with the conventional physiotherapy for overactive bladder (pelvic floor muscle training through Kegel's exercises) among 60 patients with overactive bladder symptoms on the basis of non-probability purposive sampling technique with screening for study criteria through a consultant urologist. After taking informed consent, all participants will be randomly allocated into two groups. Group A will receive pelvic floor muscles training through Kegels exercises along with transcutaneous electrical stimulation of the tibial nerve and Group B will receive pelvic floor muscles training through Kegels exercises. The treatment duration will of six weeks. Outcomes will be assessed before the start of the treatment and after the end of the treatment sessions.

02

Conditions studied

  • Overactive Bladder
  • Urge Incontinence
  • Nocturia

Keywords

  • Lower urinary tract symptoms (LUTS)
  • urge incontinence
  • overactive detrusor
  • neuromodulation therapy
  • nocturia
  • pelvic floor disease
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In context

Urinary Bladder, Overactive

858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 179 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinically diagnosed overactive bladder
  • A total OABSS score of 3 or more and an urgency score of 2 or more
  • 30-65 years old

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Acute urinary tract infection (within 15 days)
  • Any surgical procedure for urinary incontinence
  • Genito-urinary cancer history
  • Stage II pelvic organ prolapse according to pelvic organ prolapse-quantification system
  • Lesion on the site of stimulation or around it
  • Pelvic pacemakers
  • Lower limbs prostheses
  • Patients who will not be able to perform Kegel's exercises
  • An impaired sensation at the site of stimulation.
  • Patients receiving any treatment other than the prescribed medications by the referring physician (that will be the same for all patients of both groups) will be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Transcutaneous Tibial Nerve Stimulation + Pelvic Floor Muscle Strengthening

    Pelvic floor muscle strengthening through Kegel exercises along with the transcutaneous tibial nerve stimulation. Pelvic Floor Muscle-strengthening exercises - Kegels' exercises 15 repetitions, 3 times a day For 6 weeks, daily. Transcutaneous Tibial Nerve Stimulation for 30 minutes on the right lower limb 6 sessions, one per week.

    Other: Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening

  • Active comparator
    Pelvic Floor Muscle Strengthening

    Pelvic floor muscle strengthening through Kegel exercises. Pelvic floor muscle exercises - Kegels; exercises 15 repetitions, 3 times a day For 6 weeks, daily.

    Other: Pelvic floor muscles strengthening

Interventions

  • OtherTranscutaneous tibial nerve stimulation along with pelvic floor muscle srengthening

    Pelvic floor muscles strengthening: Pelvic floor muscles training involves Kegel's exercises. Kegel exercises improve the function and tone of the pelvic floor. Kegel exercises represent the voluntary contraction and relaxation of the levator ani muscle (principally the pubococcygeus and puborectalis portions), which supports the vagina, bladder, and urethra. The slow contractions help with muscle strengthening. Transcutaneous electrical stimulation of Tibial Nerve: Transcutaneous Tibial nerve stimulation is a form of treatment technique that involves the use of electrical impulses to address urinary symptoms and target the lower urinary tract.

  • OtherPelvic floor muscles strengthening

    Pelvic floor muscles strengthening: Pelvic floor muscles training involves Kegel's exercises. Kegel exercises improve the function and tone of the pelvic floor. Kegel exercises represent the voluntary contraction and relaxation of the levator ani muscle (principally the pubococcygeus and puborectalis portions), which supports the vagina, bladder, and urethra. The slow contractions help with muscle strengthening.

06

What researchers measure

Primary outcomes

  1. Change in Overactive Bladder Symptom Score from baseline at sixth week

    OABSS is a validated instrument which evaluates the four cardinal symptoms (day and nighttime frequency, urgency, and urge incontinence) of OAB in a one score. A total OABSS score of 3 or more and an urgency score of 2 or more is the recommended cut-off for diagnosing OAB, and the severity is further divided into mild (total score of 3-5 points), moderate (6-11 points) and severe (12 or more points). Patients will be evaluated at baseline and 6 weeks after the intervention through OABSS.

    Time frame: At baseline and after 6 weeks

07

Study locations

3 sites
  • Dow University Hospital
    Karachi, Sindh, Pakistan
  • Dow University of Health Sciences
    Karachi, Sindh, Pakistan
  • Sindh Institute of Physical Medicine and Rehabilitation
    Karachi, Sindh, Pakistan
08

References and documents

Publications

  • Schreiner L, dos Santos TG, Knorst MR, da Silva Filho IG. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J. 2010 Sep;21(9):1065-70. doi: 10.1007/s00192-010-1165-6. Epub 2010 May 11. PubMed 20458465 ↗
  • Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8. PubMed 31039103 ↗
  • Bhide AA, Tailor V, Fernando R, Khullar V, Digesu GA. Posterior tibial nerve stimulation for overactive bladder-techniques and efficacy. Int Urogynecol J. 2020 May;31(5):865-870. doi: 10.1007/s00192-019-04186-3. Epub 2019 Dec 18. PubMed 31853597 ↗
  • Jacomo RH, Alves AT, Lucio A, Garcia PA, Lorena DCR, de Sousa JB. Transcutaneous tibial nerve stimulation versus parasacral stimulation in the treatment of overactive bladder in elderly people: a triple-blinded randomized controlled trial. Clinics (Sao Paulo). 2020 Jan 10;75:e1477. doi: 10.6061/clinics/2020/e1477. eCollection 2020. PubMed 31939564 ↗
  • Booth J, Connelly L, Dickson S, Duncan F, Lawrence M. The effectiveness of transcutaneous tibial nerve stimulation (TTNS) for adults with overactive bladder syndrome: A systematic review. Neurourol Urodyn. 2018 Feb;37(2):528-541. doi: 10.1002/nau.23351. Epub 2017 Jul 21. PubMed 28731583 ↗
  • Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12. PubMed 30311692 ↗
  • Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002 Nov;60(5 Suppl 1):7-12; discussion 12. doi: 10.1016/s0090-4295(02)01784-3. PubMed 12493342 ↗
  • Ouslander JG. Management of overactive bladder. N Engl J Med. 2004 Feb 19;350(8):786-99. doi: 10.1056/NEJMra032662. No abstract available. PubMed 14973214 ↗
  • Eapen RS, Radomski SB. Review of the epidemiology of overactive bladder. Res Rep Urol. 2016 Jun 6;8:71-6. doi: 10.2147/RRU.S102441. eCollection 2016. PubMed 27350947 ↗
  • Homma Y, Yoshida M, Seki N, Yokoyama O, Kakizaki H, Gotoh M, Yamanishi T, Yamaguchi O, Takeda M, Nishizawa O. Symptom assessment tool for overactive bladder syndrome--overactive bladder symptom score. Urology. 2006 Aug;68(2):318-23. doi: 10.1016/j.urology.2006.02.042. PubMed 16904444 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05464589
Responsible party
Sana Subhan (Principal Investigator, Dow University of Health Sciences) — Principal investigator
First posted
Jul 19, 2022
Start date
Aug 10, 2021
Primary completion
Jul 25, 2022
Completion
Jul 25, 2022
Last update
Apr 24, 2023

Study contacts

Sana Subhan, DPT
principal investigator · Dow University of Health Sciences
Dr. Syed Imran Ahmed, MBBS, FCPS
study director · Sindh Institute of Physical Medicine and Rehabilitation
Dr. Muhammad Hammad Mithani, MBBS, FCPS
study director · Dow University Hospital
Aftab Ahmed Mirza Baig, DPT, MSAPT
study director · Sinsh Institute of Physical Medicine and Rehabilitation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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