Clinical trial NCT05464589: Effects of Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Adults
Official title: Effects of Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Adults: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urge Incontinence
Nocturia
Keywords: Lower urinary tract symptoms (LUTS)
urge incontinence
overactive detrusor
neuromodulation therapy
nocturia
pelvic floor disease
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Change in Overactive Bladder Symptom Score from baseline at sixth week
timeFrame: At baseline and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
city: Karachi
country: Pakistan
facility: Sindh Institute of Physical Medicine and Rehabilitation
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Sana Subhan, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Sindh Institute of Physical Medicine and Rehabilitation
name: Dr. Syed Imran Ahmed, MBBS, FCPS
role: STUDY_DIRECTOR
affiliation: Dow University Hospital
name: Dr. Muhammad Hammad Mithani, MBBS, FCPS
role: STUDY_DIRECTOR
affiliation: Sinsh Institute of Physical Medicine and Rehabilitation
name: Aftab Ahmed Mirza Baig, DPT, MSAPT
role: STUDY_DIRECTOR
References:
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citation: 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.
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