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Overactive BladderNCT05464589

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

A study testing Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening and Pelvic floor muscles strengthening in people with Overactive Bladder and Urge Incontinence, run by Dow University of Health Sciences at 3 sites in Pakistan.

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

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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Overactive Bladder, Urge Incontinence, Nocturia
What is being tested?
Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening and Pelvic floor muscles strengthening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesPakistan
Study dates
10 Aug 2021to 25 Jul 2022
Phase
Interventional
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 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Pakistan3 sites

  • Dow University Hospital

    Karachi, Sindh

  • Dow University of Health Sciences

    Karachi, Sindh

  • Sindh Institute of Physical Medicine and Rehabilitation

    Karachi, Sindh

Other trials in Pakistan

About this study

Official title: Effects of Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Adults: A Randomized Control Trial

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.

Being tested
Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening, Pelvic floor muscles strengthening
Keywords
Lower urinary tract symptoms (LUTS), urge incontinence, overactive detrusor, neuromodulation therapy, nocturia, pelvic floor disease
Medical subject headings
Urinary Bladder, Overactive, Urinary Incontinence, Urge, Nocturia, Lower Urinary Tract Symptoms, Pelvic Floor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengtheningOther

    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.

  • Pelvic floor muscles strengtheningOther

    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.

Study groups in NCT05464589
Study groupRoleWhat they receive
Transcutaneous Tibial Nerve Stimulation + Pelvic Floor Muscle StrengtheningExperimentalPelvic 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.
Receives: Other: Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening
Pelvic Floor Muscle StrengtheningActive comparatorPelvic floor muscle strengthening through Kegel exercises. Pelvic floor muscle exercises - Kegels; exercises 15 repetitions, 3 times a day For 6 weeks, daily.
Receives: Other: Pelvic floor muscles strengthening

What is being measured

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

  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.

    Measured: At baseline and after 6 weeks

Timeline

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

  1. First posted19 Jul 2022
  2. Study start10 Aug 2021
  3. Primary completion25 Jul 2022
  4. Study completion25 Jul 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
It is a randomized control trial. Total 60 patients will be recruited, 30 in each group. Treatment will be allocated using a random number sheet generated by SPSS software version 21. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05464589
Sponsor's protocol ID
SSubhan
Status last verified
Apr 2023
First submitted
9 Apr 2022
Last updated
24 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening and Pelvic floor muscles strengthening in people with Overactive Bladder and Urge Incontinence, run by Dow University of Health Sciences at 3 sites in Pakistan.

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 3 inclusion and 11 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Pakistan. 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 Overactive Bladder Symptom Score from baseline at sixth week (time frame: At baseline and after 6 weeks). 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 NCT05464589, which also lists 10 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 24 Apr 2023.

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