Clinical trial NCT03535857: Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence
Official title: Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overactive Bladder Syndrome
Urinary Incontinence, Urge
Keywords: overactive bladder
OAB
urge urinary incontinence
PTNS
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement
timeFrame: 12 weeks or last measurement
Secondary outcomes:
measure: Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement
timeFrame: 12 weeks or last measurement
measure: Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement
timeFrame: 12 weeks or last measurement
measure: Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement
timeFrame: 12 weeks or last measurement
measure: Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement
timeFrame: 12 weeks or last measurement
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Gnankang Sarah Napoe
state: Pennsylvania
city: Providence
country: United States
facility: WIHRI
state: Rhode Island
Study officials:
affiliation: University of Pittsburgh
name: G. Sarah Napoe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women and Infants Hospital of Rhode Island
name: Kyle Wohlrab, MD
role: PRINCIPAL_INVESTIGATOR
References: