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

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Behavioral: Bladder Training (BT); Device: Percutaneous Tibial Nerve stimulation

• Registration Number: NCT02107820
• Lead Sponsor: University Hospital Plymouth NHS Trust

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Study Start: 2014-07-24
• Primary Completion: 2019-03
• Study Completion: 2019-03-25
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'Bladder Training (BT) and PTNS	Percutaneous Tibial Nerve stimulation	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.
Percutaneous Tibial Nerve stimulation	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.
'Bladder Training (BT) and PTNS	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.

Primary Outcome Measures

Name	Time	Method
Primary outcome will reduction in number of urgency episodes (bladder diary)	3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Plymouth Hospitals NHS Trust (PHNT); 🇬🇧 Plymouth, Devon, United Kingdom