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Completed

NCT Number: NCT02107820

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

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).

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Plymouth Hospitals NHS Trust (PHNT)

Plymouth, Devon, PL6 8DH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bladder Training (BT)

Behavioral

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

Device

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 outcomes

  1. Primary outcome will reduction in number of urgency episodes (bladder diary)

    Time frame: 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 outcomes

  1. reduction in frequency

    Time frame: 24 months

    Bladder diary and International Consultation on Incontinence Questionnaire - OverActive Bladder (ICIQ-OAB) questionnaire

  2. urgency incontinence episodes

    Time frame: 24 months

    ICIQ-OAB questionnaire

  3. increase in mean void volume

    Time frame: 3 months

    Bladder diary

  4. improvement in quality of life and urgency scores

    Time frame: 24 months

    ICIQ-OAB questionnaire

Other outcomes

  1. Patient 4 point likert scale 0-3 (0 no effect, 1 better, 2 much better, 3 cured)

    Time frame: 24 months

    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

  2. Patient global impression of improvement (PGII) (5 point likert scale)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2014
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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