Clinical trial NCT02107820: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Bladder training
Percutaneous Tibial nerve stimulation
Overactive bladder
Randomised controlled study
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 84
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Primary outcome will reduction in number of urgency episodes (bladder diary)
timeFrame: 3 months
Secondary outcomes:
measure: reduction in frequency
timeFrame: 24 months
measure: urgency incontinence episodes
timeFrame: 24 months
measure: increase in mean void volume
timeFrame: 3 months
measure: improvement in quality of life and urgency scores
timeFrame: 24 months
Other outcomes:
measure: Patient 4 point likert scale 0-3 (0 no effect, 1 better, 2 much better, 3 cured)
timeFrame: 24 months
measure: Patient global impression of improvement (PGII) (5 point likert scale)
timeFrame: 24 months
Locations:
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust (PHNT)
state: Devon
Study officials:
affiliation: Plymouth Hospitals NHS Trust (PHNT)
name: Anupreet Dua, MBBS, MRCOG
role: PRINCIPAL_INVESTIGATOR
References: