BUTTON: Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence

Sponsor

Gnankang Sarah Napoe (Other)

Overall Status

Recruiting

CT.gov ID

NCT03535857

Collaborator

(none)

Enrollment

Locations

Arms

68.5

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Syndrome Urinary Incontinence, Urge	Device: PTNS	N/A

Detailed Description

Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence

Actual Study Start Date :

Apr 17, 2018

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Unilateral PTNS 34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period	Device: PTNS Use of PTNS on the ankle for 30 minutes
Experimental: Bilateral PTNS 34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period	Device: PTNS Use of PTNS on the ankle for 30 minutes

Arm

Intervention/Treatment

Active Comparator: Unilateral PTNS

34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period

Device: PTNS

Use of PTNS on the ankle for 30 minutes

Experimental: Bilateral PTNS

34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period

Device: PTNS

Use of PTNS on the ankle for 30 minutes

Outcome Measures

Primary Outcome Measures

Change in OAB symptom severity score [12 weeks]
Overactive Bladder questionnaire short form symptom severity will be administered at baseline, 4 weeks, 8 weeks then 12 weeks. The questionnaire score ranges from 0 to 100. Those with more bothersome symptoms will have higher scores. The investigators expect more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation.

Secondary Outcome Measures

Change in daily number of voids [12 weeks]
Number of voids at baseline will be compared to the number of voids after completion of PTNS at 12 weeks
Change in number of incontinence episodes per 24 hours [12 weeks]
The number of incontinence episodes will be calculated from the voiding diary
Change in nocturia episodes [12 weeks]
A bladder diary will be used to determine how many episodes of voiding occurs at night (nocturia). Baseline nocturia will be compared to nocturia at 12 weeks
Evaluate impact of treatment on quality of life [12 weeks]
The incontinence impact questionnaire will be used to measure impact on qualify of life. The questionnaire score range from 0 to 100 with higher scores indicating worse quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy
Patients who consent to participate in the study
Patients on pharmacologic therapy at the time of recruitment can continue their treatment

Exclusion Criteria:

Pregnant patients
Patients with pacemakers of implantable defibrillators
Patients with neurogenic bladder
Patients who have received Botox or have an implant for sacral nerve stimulation
Patients with uncontrolled bleeding disorder
Patients with unhealed ulcers or with leg edema surrounding medial malleolus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gnankang Sarah Napoe	Pittsburgh	Pennsylvania	United States	15203
2	WIHRI	Providence	Rhode Island	United States	02905

Sponsors and Collaborators

Gnankang Sarah Napoe

Investigators

Principal Investigator: G. Sarah Napoe, MD, University of Pittsburgh
Principal Investigator: Kyle Wohlrab, MD, Women and Infants Hospital of Rhode Island