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

NCT ID: NCT05464589

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2022-07-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscles strengthening

Intervention Type: 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.

Interventions

Transcutaneous 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.

Intervention Type: OTHER

Pelvic 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Sana Subhan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sana Subhan, DPT

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Dr. Syed Imran Ahmed, MBBS, FCPS

Role: STUDY_DIRECTOR

Sindh Institute of Physical Medicine and Rehabilitation

Dr. Muhammad Hammad Mithani, MBBS, FCPS

Role: STUDY_DIRECTOR

Dow University Hospital

Aftab Ahmed Mirza Baig, DPT, MSAPT

Role: STUDY_DIRECTOR

Sinsh Institute of Physical Medicine and Rehabilitation

Locations

Dow University Hospital

Karachi, Sindh, Pakistan

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Sindh Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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Other Identifiers

SSubhan

Identifier Type: -

Identifier Source: org_study_id