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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Plymouth Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT02107820
First received: April 4, 2014
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Overactive Bladder
Behavioral: Bladder Training (BT)
Device: Percutaneous Tibial Nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Plymouth Hospitals NHS Trust:

Primary Outcome Measures:
  • Primary outcome will reduction in number of urgency episodes (bladder diary) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Bladder diary and International Consultation on Incontinence Questionnaire - OverActive Bladder (ICIQ-OAB) questionnaire

  • urgency incontinence episodes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    ICIQ-OAB questionnaire

  • increase in mean void volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Bladder diary

  • improvement in quality of life and urgency scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    ICIQ-OAB questionnaire


Other Outcome Measures:
  • Patient 4 point likert scale 0-3 (0 no effect, 1 better, 2 much better, 3 cured) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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

  • Patient global impression of improvement (PGII) (5 point likert scale) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: May 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107820

Contacts
Contact: Anupreet Dua, MBBS, MRCOG anudua@nhs.net
Contact: Robert M Freeman, MD robert.freeman@nhs.net

Locations
United Kingdom
Plymouth Hospitals NHS Trust (PHNT) Not yet recruiting
Plymouth, Devon, United Kingdom, PL6 8DH
Contact: Christopher M Rollinson, PhD    01752 431045    crollinson@nhs.net   
Sub-Investigator: Robert M Freeman, MD         
Principal Investigator: Anupreet Dua, MBBS, MRCOG         
Sub-Investigator: Luigi Bomberi, MD         
Sub-Investigator: Kirsty White         
Sub-Investigator: Carol George, DipHE         
Sponsors and Collaborators
Plymouth Hospitals NHS Trust
Investigators
Principal Investigator: Anupreet Dua, MBBS, MRCOG Plymouth Hospitals NHS Trust (PHNT)
  More Information

No publications provided

Responsible Party: Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02107820     History of Changes
Other Study ID Numbers: 14/P/036
Study First Received: April 4, 2014
Last Updated: April 24, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Plymouth Hospitals NHS Trust:
Bladder training
Percutaneous Tibial nerve stimulation
Overactive bladder
Randomised controlled study

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014