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

Overactive Bladder Syndrome Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03535857
• Other study ID #: STUDY19100230
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: G. Sarah Napoe, MD
• Phone: 412-641-7850
• Email: napoegs[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder Syndrome
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Device:
• PTNS
Use of PTNS on the ankle for 30 minutes

Locations

Country	Name	City	State
United States	Gnankang Sarah Napoe	Pittsburgh	Pennsylvania
United States	WIHRI	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Gnankang Sarah Napoe

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in OAB symptom severity score	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.	12 weeks
Secondary	Change in daily number of voids	Number of voids at baseline will be compared to the number of voids after completion of PTNS at 12 weeks	12 weeks
Secondary	Change in number of incontinence episodes per 24 hours	The number of incontinence episodes will be calculated from the voiding diary	12 weeks
Secondary	Change in nocturia episodes	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	12 weeks
Secondary	Evaluate impact of treatment on quality of life	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.	12 weeks