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

NCT05464589 | Completed

• 1 other identifier: SSubhan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Overactive Bladder; Urge Incontinence; Nocturia

Keywords

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

Outcome Measures

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.

  At baseline and after 6 weeks

Study Arms (2)

Transcutaneous Tibial Nerve Stimulation + Pelvic Floor Muscle Strengthening

EXPERIMENTAL

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

Pelvic Floor Muscle Strengthening

ACTIVE COMPARATOR

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

Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening OTHER

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.

Transcutaneous Tibial Nerve Stimulation + Pelvic Floor Muscle Strengthening

Pelvic floor muscles strengthening OTHER

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.

Pelvic Floor Muscle Strengthening

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (3)

Dow University Hospital

Karachi, Sindh, Pakistan

Location

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

Sindh Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, Pakistan

Location

Related Publications (10)

• 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.

  PMID: 20458465 BACKGROUND

• 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.

  PMID: 31039103 BACKGROUND

• 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.

  PMID: 31853597 BACKGROUND

• 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.

  PMID: 31939564 BACKGROUND

• 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.

  PMID: 28731583 BACKGROUND

• 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.

  PMID: 30311692 BACKGROUND

• 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.

  PMID: 12493342 BACKGROUND

• Ouslander JG. Management of overactive bladder. N Engl J Med. 2004 Feb 19;350(8):786-99. doi: 10.1056/NEJMra032662. No abstract available.

  PMID: 14973214 BACKGROUND

• 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.

  PMID: 27350947 BACKGROUND

• 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.

  PMID: 16904444 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Nocturia; Lower Urinary Tract Symptoms; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Pregnancy Complications

Study Officials

• Sana Subhan, DPT

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Dr. Syed Imran Ahmed, MBBS, FCPS

  Sindh Institute of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

• Dr. Muhammad Hammad Mithani, MBBS, FCPS

  Dow University Hospital

  STUDY DIRECTOR

• Aftab Ahmed Mirza Baig, DPT, MSAPT

  Sinsh Institute of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome accessor involved in the clinical trial will be prevented from having knowledge of the interventions to the individual participants of each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: July 19, 2022
• Study Start: August 10, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

PA (3)