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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bladder Training (BT)
Percutaneous Tibial Nerve stimulation
Sponsored by
University Hospital Plymouth NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Bladder training, Percutaneous Tibial nerve stimulation, Overactive bladder, Randomised controlled study

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Plymouth Hospitals NHS Trust (PHNT)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Percutaneous Tibial Nerve stimulation

'Bladder Training (BT) and PTNS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2014
Last Updated
September 3, 2019
Sponsor
University Hospital Plymouth NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02107820
Brief Title
Does Bladder Training Improve the Efficacy of Nerve Stimulation in Women With Refractory Overactive Bladders
Official Title
Does Bladder Training (BT) Improve the Efficacy of Percutaneous Tibial Nerve Stimulation (PTNS) in Women With Refractory Overactive Bladder (OAB) - A Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 24, 2014 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Plymouth NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Bladder training, Percutaneous Tibial nerve stimulation, Overactive bladder, Randomised controlled study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Tibial Nerve stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
'Bladder Training (BT) and PTNS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bladder Training (BT)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Percutaneous Tibial Nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary outcome will reduction in number of urgency episodes (bladder diary)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
reduction in frequency
Description
Bladder diary and International Consultation on Incontinence Questionnaire - OverActive Bladder (ICIQ-OAB) questionnaire
Time Frame
24 months
Title
urgency incontinence episodes
Description
ICIQ-OAB questionnaire
Time Frame
24 months
Title
increase in mean void volume
Description
Bladder diary
Time Frame
3 months
Title
improvement in quality of life and urgency scores
Description
ICIQ-OAB questionnaire
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Patient 4 point likert scale 0-3 (0 no effect, 1 better, 2 much better, 3 cured)
Description
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
Time Frame
24 months
Title
Patient global impression of improvement (PGII) (5 point likert scale)
Time Frame
24 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anupreet Dua, MBBS, MRCOG
Organizational Affiliation
Plymouth Hospitals NHS Trust (PHNT)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Plymouth Hospitals NHS Trust (PHNT)
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

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

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