Overactive BladderNCT02107820
Does Bladder Training Improve the Efficacy of Nerve Stimulation in Women With Refractory Overactive Bladders
A study testing Bladder Training (BT) and Percutaneous Tibial Nerve stimulation in people with Overactive Bladder, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Bladder Training (BT) and Percutaneous Tibial Nerve stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2014to 25 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All women with refractory OAB who are offered PTNS as a treatment option
Who cannot join
- Who cannot give informed consent.
- Women in whom PTNS is contraindicated. This includes women who have:
- Gross leg oedema A pacemaker
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust (PHNT)
Plymouth, Devon, PL6 8DH
About this study
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
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).
Read more
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
- Being tested
- Bladder Training (BT), Percutaneous Tibial Nerve stimulation
- Keywords
- Bladder training, Percutaneous Tibial nerve stimulation, Overactive bladder, Randomised controlled study
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder Training (BT)Behavioural
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Bladder Training (BT); Device: Percutaneous Tibial Nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
reduction in frequency
Bladder diary and International Consultation on Incontinence Questionnaire - OverActive Bladder (ICIQ-OAB) questionnaire
Measured: 24 months
urgency incontinence episodes
ICIQ-OAB questionnaire
Measured: 24 months
increase in mean void volume
Bladder diary
Measured: 3 months
improvement in quality of life and urgency scores
ICIQ-OAB questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start24 Jul 2014
- Primary completionMar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anupreet Dua, MBBS, MRCOG, Principal investigator, Plymouth Hospitals NHS Trust (PHNT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107820
- Sponsor's protocol ID
- 14/P/036
- Status last verified
- Sep 2019
- First submitted
- 4 Apr 2014
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02107820
- Acronym / sponsor ID
- 14/P/036
- Conditions
- Overactive Bladder
- Keywords
- Bladder training, Percutaneous Tibial nerve stimulation, Overactive bladder, Randomised controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 24 Jul 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Tibial Nerve stimulation | Active comparator | Device: Percutaneous Tibial Nerve stimulationA 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 | Experimental | Behavioral: Bladder Training (BT), Device: Percutaneous Tibial Nerve stimulationAll 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All women with refractory OAB who are offered PTNS as a treatment option
Key exclusion criteria (3 listed)
- Who cannot give informed consent.
- Women in whom PTNS is contraindicated. This includes women who have:
- Gross leg oedema A pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 'Bladder Training (BT) and PTNS |
| Percutaneous Tibial Nerve stimulationA 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 | 'Bladder Training (BT) and PTNS, Percutaneous Tibial Nerve stimulation |
Primary outcome
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.
4 secondary outcomes
reduction in frequency
Time frame: 24 months
urgency incontinence episodes
Time frame: 24 months
increase in mean void volume
Time frame: 3 months
improvement in quality of life and urgency scores
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anupreet Dua, MBBS, MRCOG principal investigator
Plymouth Hospitals NHS Trust (PHNT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder Training (BT) and Percutaneous Tibial Nerve stimulation in people with Overactive Bladder, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome will reduction in number of urgency episodes (bladder diary) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.