Idiopathic Overactive BladderPESTOBNCT01783392
Peripheral Electrical Stimulation for the Treatment of Overactive Bladder
A study testing Transcutaneous Electrical Nerve Stimulation in people with Idiopathic Overactive Bladder, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Overactive Bladder
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Mar 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females, at least 18 years of age
- Documented symptoms of idiopathic overactive bladder for at least 3 months
- Failure on primary OAB treatment, such as behavior modification or fluid/diet management
- Patients can remain on stable medication
- Willing and capable of understanding and complying with all requirements of the protocol
- Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits
Who cannot join
- Urinary retention or post voiding residual greater than 100 ml
- Clinically significant bladder outlet obstruction
- Stress predominant mixed urinary incontinence
- Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury.
- Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
- Denovo OAB following pelvic surgery sub-urethral sling Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 6 months
Show all 19Show fewer
- Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months
- Any form of electric stimulation to the pelvis or lower limbs within 4 weeks
- Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ ProlapseQuantification (POPQ) criteria.
- Prior periurethral or transurethral bulking agent injections for bladder problems within the past 12 months.
- History of pelvic radiation therapy
- Any skin conditions affecting treatment sites
- Lacking dexterity to properly utilize the components of the stimulator system.
- Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.),
- Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
- Recurrent Urinary Tract Infections UTI (>3 UTI's in the past year)
- History of, or current, lower tract genitourinary malignancies
- Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study
- Any other clinical trial within 6 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).
- Conditions
- Idiopathic Overactive Bladder
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Keywords
- overactive bladder, transcutaneous posterior tibial nerve stimulation, placebo PTNS
- 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.
Transcutaneous Electrical Nerve StimulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Posterior Tibial Nerve Stimulation | Active comparator | Transcutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve and sets the stimulation intensity to a comfortable level. Receives: Procedure: Transcutaneous Electrical Nerve Stimulation |
| Bilateral Posterior Tibial Nerve Stimulation | Active comparator | Transcutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve on both legs and sets the stimulation intensity to a comfortable level. Receives: Procedure: Transcutaneous Electrical Nerve Stimulation |
| Shoulder stimulation | Active comparator | Stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode and the anode electrodes on the lateral side of the left shoulder. Receives: Procedure: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of voiding
The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary.
Measured: baseline, 4 weeks
Change in Patient Perception of Bladder Condition (PPBC)
Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment.
Measured: baseline, 4 weeks
Secondary outcomes (3)
Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire
Change in symptom severity score and HRQL score from baseline to after 4weeks of the treatment.
Measured: baseline, 4 weeks
Changes in the mental/physical scores of RAND36
Measured: baseline, 4 weeks
Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire
Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire from baseline to after 4 weeks of the treatment
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Chapple, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783392
- Sponsor's protocol ID
- STH16245
- Acronym
- PESTOB
- Status last verified
- May 2015
- First submitted
- 23 Jan 2013
- Last updated
- 22 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Electrical Stimulation for the Treatment of Overactive Bladder
- ClinicalTrials.gov ID
- NCT01783392
- Acronym / sponsor ID
- PESTOB / STH16245
- Conditions
- Idiopathic Overactive Bladder
- Keywords
- overactive bladder, transcutaneous posterior tibial nerve stimulation, placebo PTNS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Feb 2013 (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.
This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral Posterior Tibial Nerve Stimulation | Active comparator | Procedure: Transcutaneous Electrical Nerve StimulationTranscutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve and sets the stimulation intensity to a comfortable level. |
| Bilateral Posterior Tibial Nerve Stimulation | Active comparator | Procedure: Transcutaneous Electrical Nerve StimulationTranscutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve on both legs and sets the stimulation intensity to a comfortable level. |
| Shoulder stimulation | Active comparator | Procedure: Transcutaneous Electrical Nerve StimulationStimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode and the anode electrodes on the lateral side of the left shoulder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and Females, at least 18 years of age
- Documented symptoms of idiopathic overactive bladder for at least 3 months
- Failure on primary OAB treatment, such as behavior modification or fluid/diet management
- Patients can remain on stable medication
- Willing and capable of understanding and complying with all requirements of the protocol
Key exclusion criteria (19 listed)
- Urinary retention or post voiding residual greater than 100 ml
- Clinically significant bladder outlet obstruction
- Stress predominant mixed urinary incontinence
- Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury.
- Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation | Procedure or surgery | Bilateral Posterior Tibial Nerve Stimulation, Shoulder stimulation, Unilateral Posterior Tibial Nerve Stimulation |
Primary outcome
Change in frequency of voiding
Time frame: baseline, 4 weeks
The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary.
Change in Patient Perception of Bladder Condition (PPBC)
Time frame: baseline, 4 weeks
Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment.
3 secondary outcomes
Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire
Time frame: baseline, 4 weeks
Changes in the mental/physical scores of RAND36
Time frame: baseline, 4 weeks
Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire
Time frame: baseline, 4 weeks
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 22 May 2015.
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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.
Christopher Chapple principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Idiopathic Overactive Bladder, run by Sheffield Teaching Hospitals NHS Foundation 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 6 inclusion and 19 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 22 May 2015. 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?
Change in frequency of voiding (time frame: baseline, 4 weeks). The study lists 2 primary outcomes in all. 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 22 May 2015.