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

NCT02107820 | Completed

• 1 other identifier: 14/P/036
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Overactive Bladder

Keywords

Bladder training; Percutaneous Tibial nerve stimulation; Overactive bladder; Randomised controlled study

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (4)

• reduction in frequency

  24 months

• urgency incontinence episodes

  24 months

• increase in mean void volume

  3 months

• improvement in quality of life and urgency scores

  24 months

Other Outcomes (2)

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

  24 months

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

  24 months

Study Arms (2)

Percutaneous Tibial Nerve stimulation

ACTIVE COMPARATOR

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

'Bladder Training (BT) and PTNS

EXPERIMENTAL

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); Device: Percutaneous Tibial Nerve stimulation

Interventions

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.

'Bladder Training (BT) and PTNS

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.

'Bladder Training (BT) and PTNS; Percutaneous Tibial Nerve stimulation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All women with refractory OAB who are offered PTNS as a treatment option

You may not qualify if:

• Who cannot give informed consent.
• Women in whom PTNS is contraindicated. This includes women who have:
• Gross leg oedema A pacemaker

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Plymouth Hospitals NHS Trust (PHNT)

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

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

Study Officials

• Anupreet Dua, MBBS, MRCOG

  Plymouth Hospitals NHS Trust (PHNT)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: July 24, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 25, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

GB (1)