Does Bladder Training Improve the Efficacy of Nerve Stimulation in Women With Refractory Overactive Bladders

Does Bladder Training (BT) Improve the Efficacy of Percutaneous Tibial Nerve Stimulation (PTNS) in Women With Refractory Overactive Bladder (OAB) - A Randomised Controlled Study

Overactive Bladder (OAB) is a chronic condition defined as urgency with or without incontinence usually associated with frequency and nocturia. It is a common condition affecting 15-45% of adults and constitutes a significant proportion of patients attending urogynaecology clinics. OAB is known to have a significant impact on the physical, social and emotional quality of life and sexual function in women. The treatment of OAB is initially conservative with bladder training followed by pharmacotherapy.

Evidence from a recent Cochrane review on treatment of OAB suggests that the efficacy of anticholinergics in treatment of OAB is enhanced when combined with BT. Women who fail to improve with these initial measures are offered Intravesical Botox or neuromodulation in the form of Percutaneous Tibial Nerve Stimulation (PTNS) or Sacral Nerve Stimulation (SNS).

PTNS has also been shown to more effective than pharmacotherapy with anticholinergics. In 2010 National Institute of Clinical Excellences (NICE) issued guidance stating '"PTNS for OAB demonstrates effectiveness without major safety concerns"

We hypothesise that the outcome of PTNS will improve if the PTNS sessions are combined with bladder training (BT).

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Percutaneous Tibial Nerve stimulation; Behavioral: Bladder Training (BT)

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Plymouth Hospitals NHS Trust (PHNT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All women with refractory OAB who are offered PTNS as a treatment option

Exclusion Criteria:

• Who cannot give informed consent.
• Women in whom PTNS is contraindicated. This includes women who have:

Gross leg oedema A pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous Tibial Nerve stimulation; A needle electrode insertion site is located on the inner aspect of either leg approximately three fingerbreadths (5 cm or 2") cephalad to the medial malleolus and approximately one fingerbreadth (2 cm or ¾") posterior to the tibia. The needle electrode head is gently tapped to pierce the skin, maintaining a 60° angle, and insert to a depth of approximately 2cm. The electrode is then connected to the stimulator and the current setting needed is determined by the test mode on the stimulator. Once the current setting is known, the stimulator is started on the therapy mode which delivers the current for 30 minutes and shuts off automatically after 30 minutes. The needle is then removed and stimulator disconnected. The treatment involves twelve weekly sessions of 30 minutes each.	Device: Percutaneous Tibial Nerve stimulation; A needle electrode insertion site is located on the inner aspect of either leg approximately three fingerbreadths (5 cm or 2") cephalad to the medial malleolus and approximately one fingerbreadth (2 cm or ¾") posterior to the tibia. The needle electrode head is gently tapped to pierce the skin, maintaining a 60° angle, and insert to a depth of approximately 2cm. The electrode is then connected to the stimulator and the current setting needed is determined by the test mode on the stimulator. Once the current setting is known, the stimulator is started on the therapy mode which delivers the current for 30 minutes and shuts off automatically after 30 minutes. The needle is then removed and stimulator disconnected. The treatment involves twelve weekly sessions of 30 minutes each.
Experimental: 'Bladder Training (BT) and PTNS; All patients randomised to PTNS + BT group will have BT with the nurse for 20 minutes during PTNS sessions (which last 30 minutes). Since BT is recommended by NICE for a duration of 6 weeks. BT will be discussed for the first 6 sessions of the 12 week PTNS treatment cycle.	Device: Percutaneous Tibial Nerve stimulation; A needle electrode insertion site is located on the inner aspect of either leg approximately three fingerbreadths (5 cm or 2") cephalad to the medial malleolus and approximately one fingerbreadth (2 cm or ¾") posterior to the tibia. The needle electrode head is gently tapped to pierce the skin, maintaining a 60° angle, and insert to a depth of approximately 2cm. The electrode is then connected to the stimulator and the current setting needed is determined by the test mode on the stimulator. Once the current setting is known, the stimulator is started on the therapy mode which delivers the current for 30 minutes and shuts off automatically after 30 minutes. The needle is then removed and stimulator disconnected. The treatment involves twelve weekly sessions of 30 minutes each.; Behavioral: Bladder Training (BT); All patients randomised to PTNS + BT group will have BT with the nurse for 20 minutes during PTNS sessions (which last 30 minutes). Since BT is recommended by NICE for a duration of 6 weeks. BT will be discussed for the first 6 sessions of the 12 week PTNS treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome will reduction in number of urgency episodes (bladder diary)	All patients complete a bladder diary (A record of fluid intake, voided volumes, urgency and incontinence episodes for 3 days) prior to commencement and at 3 months.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction in frequency	Bladder diary and International Consultation on Incontinence Questionnaire - OverActive Bladder (ICIQ-OAB) questionnaire	24 months
urgency incontinence episodes	ICIQ-OAB questionnaire	24 months
increase in mean void volume	Bladder diary	3 months
improvement in quality of life and urgency scores	ICIQ-OAB questionnaire	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient 4 point likert scale 0-3 (0 no effect, 1 better, 2 much better, 3 cured)	Patients are asked about the subjective effect of the treatment on a 4 point likert scale 0-3 (0 no effect, 1 better, 2 much better, 3 cured) during the treatment cycle	24 months
Patient global impression of improvement (PGII) (5 point likert scale)		24 months

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust
• Investigators: Principal Investigator: Anupreet Dua, MBBS, MRCOG, Plymouth Hospitals NHS Trust (PHNT)

Study record dates

Study Major Dates

• Study Start: July 24, 2014
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 25, 2019

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Overactive bladder; Bladder training; Percutaneous Tibial nerve stimulation; Randomised controlled study
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 14/P/036