search
Back to results

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

Primary Purpose

Overactive Bladder, Urge Incontinence, Nocturia

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening
Pelvic floor muscles strengthening
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Lower urinary tract symptoms (LUTS), urge incontinence, overactive detrusor, neuromodulation therapy, nocturia, pelvic floor disease

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dow University Hospital
  • Dow University of Health Sciences
  • Sindh Institute of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transcutaneous Tibial Nerve Stimulation + Pelvic Floor Muscle Strengthening

Pelvic Floor Muscle Strengthening

Arm Description

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.

Pelvic floor muscle strengthening through Kegel exercises. Pelvic floor muscle exercises - Kegels; exercises 15 repetitions, 3 times a day For 6 weeks, daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2022
Last Updated
April 21, 2023
Sponsor
Dow University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05464589
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urge Incontinence, Nocturia
Keywords
Lower urinary tract symptoms (LUTS), urge incontinence, overactive detrusor, neuromodulation therapy, nocturia, pelvic floor disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Tibial Nerve Stimulation + Pelvic Floor Muscle Strengthening
Arm Type
Experimental
Arm Description
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.
Arm Title
Pelvic Floor Muscle Strengthening
Arm Type
Active Comparator
Arm Description
Pelvic floor muscle strengthening through Kegel exercises. Pelvic floor muscle exercises - Kegels; exercises 15 repetitions, 3 times a day For 6 weeks, daily.
Intervention Type
Other
Intervention Name(s)
Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening
Intervention Description
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
Intervention Name(s)
Pelvic floor muscles strengthening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Overactive Bladder Symptom Score from baseline at sixth week
Description
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.
Time Frame
At baseline and after 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sana Subhan, DPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Syed Imran Ahmed, MBBS, FCPS
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr. Muhammad Hammad Mithani, MBBS, FCPS
Organizational Affiliation
Dow University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, DPT, MSAPT
Organizational Affiliation
Sinsh Institute of Physical Medicine and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Dow University Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Sindh Institute of Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20458465
Citation
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.
Results Reference
background
PubMed Identifier
31039103
Citation
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.
Results Reference
background
PubMed Identifier
31853597
Citation
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.
Results Reference
background
PubMed Identifier
31939564
Citation
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.
Results Reference
background
PubMed Identifier
28731583
Citation
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.
Results Reference
background
PubMed Identifier
30311692
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.
Results Reference
background
PubMed Identifier
12493342
Citation
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.
Results Reference
background
PubMed Identifier
14973214
Citation
Ouslander JG. Management of overactive bladder. N Engl J Med. 2004 Feb 19;350(8):786-99. doi: 10.1056/NEJMra032662. No abstract available.
Results Reference
background
PubMed Identifier
27350947
Citation
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.
Results Reference
background
PubMed Identifier
16904444
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs