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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05464589
Enrollment
60
Registered
2022-07-19
Start date
2021-08-10
Completion date
2022-07-25
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia, Overactive Bladder, Urge Incontinence

Keywords

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

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.

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.

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome accessor involved in the clinical trial will be prevented from having knowledge of the interventions to the individual participants of each group.

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.

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Overactive Bladder Symptom Score from baseline at sixth weekAt baseline and after 6 weeksOABSS 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026