Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments

Overactive Bladder Clinical Trial

Official title:

Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01940367
• Other study ID #: 385408-2
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 13, 2013
• Last updated: April 27, 2016
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether transcutaneous sacral nerve stimulation (TENS SNS) versus percutaneous tibial nerve stimulation (PTNS) is a more effective therapeutic option for subjects with idiopathic overactive bladder (OAB) who have failed conventional therapy. Our primary hypothesis is that TENS therapy is a more effective treatment option due to ease of use and improved subject compliance with this form of therapy.

Description:

To compare the long-term efficacy, subject compliance, and subject satisfaction of percutaneous tibial nerve stimulation (PTNS) therapy versus transcutaneous electrical sacral nerve stimulation (TENS) for the treatment of subjects with idiopathic overactive bladder. Previous short-term studies suggest that these therapies have equal efficacy in improving OAB symptoms, but we hypothesize that long-term efficacy and success is actually higher in the TENS group due to ease of use, since subjects can self-administer this therapy. Secondary goals are to evaluate subject quality of life improvement scores, bladder diary scores (change in the frequency of urination), and changes in urodynamic studies while undergoing these therapies.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 114
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• Age >18 years

• Predominant complaint urge urinary incontinence (3 or more episodes per week) OR overactive bladder (8 or more voids per day, and/or 2 or more voids per night)

• Failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training)

• Failed trial of anticholinergic either due to inability to take the medication, adverse reaction to medication, or no improvement on medication

• Willing and mentally competent to participate in study

• Willing to complete study questionnaires

• No contraindications to undergoing PTNS or TENS therapy

Exclusion Criteria:

• Age < 18 years

• Presence of urinary fistula

• Male. (Males will be excluded because of the different etiology of overactive bladder for males which is primarily caused by prostate problems for men versus the primarily idiopathic cause in women).

• Recurrent or current urinary tract infection (5 or more infections in the last 12 months)

• Bladder stones

• Bladder cancer or suspected bladder cancer

• Hematuria

• Pregnancy or planning to become pregnant during the study (urine pregnancy test will be administered to those who are premenopausal and who have not had a hysterectomy)

• Central or peripheral neurologic disorders such as Multiple Sclerosis, Parkinson's disease, spina bifida, or other spinal cord lesion

• Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (sacrum or ankle/leg).

• Uncontrolled diabetes

• Diabetes with peripheral nerve involvement

• On anticoagulants

• Current use of anticholinergics or use within the last 4 weeks

• Current use of botox bladder injections or bladder botox injection within the last year

• Current use of interstim therapy or currently implanted interstim device or leads

• Bladder outlet obstruction

• Urinary retention or gastric retention

• Painful Bladder Syndrome/Interstitial Cystitis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urge Urinary Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Device:
• PTNS (Percutaneous Tibial Nerve Stimulation
PTNS therapy is performed as follows; the subject sits in a frog leg position in a chair. The area where the needle will be placed is cleaned with an alcohol swab. A 34 gauge needle (equivalent to an acupuncture needle) is inserted percutaneously approximately 5 cm cephalad to the medial malleolus of the right or left ankle (subject choice) at a 60 degree angle. A surface electrode is placed on the medial aspect of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage (9 V) electrical stimulator (Urgent PC). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot. The current is then set to the highest level tolerable to the subject (0-10 mA) and the subject undergoes therapy for 30 minutes.
• TENS (Transcutaneous Electrical Nerve Stimulation)
TENS therapy will be administered as follows: Surface electrodes, 2" x 2" in diameter, will be placed over sacral foramen S2-4, bilaterally, using 2 channels (4 electrodes total) - Approximate locations are over posterior superior iliac spine and inferior lateral angle of sacrum. Sticker electrodes for the duration of the study will be issued to subjects. They are adhesive and can be re-used for up to 3-4 weeks with proper skin care and electrode care. The electrodes will be connected to the TENS (Transcutaneous Electrical Nerve Stimulation) device and the following settings will be pre-set: Mode: Burst Cycle: 10 seconds Frequency: 10 Hz Pulse Width: 250 µs Intensity: to subject comfort level

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Fort Belvoir Community Hospital	Fort Belvoir	Virginia
United States	Portsmouth Naval Hospital	Portsmouth	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	International Urogynecological Association (Grant), Section on Women's Health (Grant)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial	The primary response variable is 'success' at 1 year, defined as a 50% or more reduction in the total number of incontinence episodes, or a 25% or more reduction in number of daily or nightly voids AND that the patient continues to use the therapy at one year. Therefore primary response is: 50% reduction in incontinence, OR 25% reduction in nightly voids AND continued use of therapy at one year.	2 years	No
Secondary	Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial	Participant compliance defined as 75% adherence to the recommended use for each device.	2 years	No
Secondary	Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial	Changes in the OAB-q (Overactive Bladder Questionnaire), the PFDI (Pelvic Floor Distress Inventory), and the FSFI (Female Sexual Function Index)	2 Years	No
Secondary	Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial	Changes in urodynamic studies (i.e. bladder capacity, uroflow rate, post-void residual).	2 Years	No