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

Not Applicable

Completed

• Conditions: Overactive Bladder

• 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

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