Overactive BladderNCT03104101
Transcutaneous Posterior Tibial Nerve Electrostimulation With Low Dose Trospium Chloride in OAB in Females
A study testing TPTNS+Drug and TPTNS in people with Overactive Bladder, run by Alexandria University.
Trial summary
This study was done to verify whether the combination of transcutaneous posterior tibial nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- TPTNS+Drug and TPTNS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 5 Mar 2016
- 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 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Thirty adult female patients having OAB symptoms (wet type) and proved to have detrusor overactivity by urodynamics
Who cannot join
- Patients having urinary tract infection or bladder outlet obstruction.
- Patients having neurological diseases.
- Patients having gynecological problems as genital infection, pelvic organ prolapse or genital tumors.
- Patients with electronic implants such as heart pacemakers.
- During pregnancy
- Patients subject to seizures
About this study
Official title: Evaluation of Transcutaneous Posterior Tibial Nerve Electro Stimulation With or Without Low Dose Trospium Chloride in the Management of Overactive Bladder in Females
This study was done to verify whether the combination of transcutaneous posterior tibial nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy.
Read the detailed description
The investigators randomized 30 women with OAB, in two groups: G I (15 patients) received 30 minutes TPTNS, three times a week; GII (15 patients) received TPTNS plus Low dose trospium chloride (20 mg once daily); all for 8 weeks. Patients were evaluated using Overactive Bladder Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7 (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.
- Conditions
- Overactive Bladder
- Being tested
- TPTNS+Drug, TPTNS
- Keywords
- PTNS, Neuromodulation, TPTNS, Trospium chloride
- 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.
TPTNS+DrugCombination product
one tablet Trospium Chloride 20 mg once daily Plus TPTNS
TPTNSDevice
Surface adhesive electrodes placed on the skin above medial malleolus
| Study group | Role | What they receive |
|---|---|---|
| TPTNS | Active comparator | Those who received Transcutaneous posterior tibial nerve stimulation sessions only Receives: Device: TPTNS |
| TPTNS+Drug | Active comparator | Those who received Transcutaneous posterior tibial nerve stimulation sessions plus 20 mg Trospium chloride Receives: Combination Product: TPTNS+Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Improvement in the questionnaire scores and associated willingness of the patient to continue treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Nov 2014
- Primary completion30 Nov 2015
- Study completion5 Mar 2016
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.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gaber Abdulfattah Ali Abulseoud, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104101
- Sponsor's protocol ID
- Alexandria University
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transcutaneous Posterior Tibial Nerve Electro Stimulation With or Without Low Dose Trospium Chloride in the Management of Overactive Bladder in Females
- ClinicalTrials.gov ID
- NCT03104101
- Acronym / sponsor ID
- Alexandria University
- Conditions
- Overactive Bladder
- Keywords
- PTNS, Neuromodulation, TPTNS, Trospium chloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 5 Mar 2016 (actual)
- First posted
- 7 Apr 2017 (actual)
- 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 study was done to verify whether the combination of transcutaneous posterior tibial nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy.
Detailed description
The investigators randomized 30 women with OAB, in two groups: G I (15 patients) received 30 minutes TPTNS, three times a week; GII (15 patients) received TPTNS plus Low dose trospium chloride (20 mg once daily); all for 8 weeks. Patients were evaluated using Overactive Bladder Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7 (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPTNS | Active comparator | Device: TPTNSThose who received Transcutaneous posterior tibial nerve stimulation sessions only |
| TPTNS+Drug | Active comparator | Combination Product: TPTNS+DrugThose who received Transcutaneous posterior tibial nerve stimulation sessions plus 20 mg Trospium chloride |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Thirty adult female patients having OAB symptoms (wet type) and proved to have detrusor overactivity by urodynamics
Key exclusion criteria (6 listed)
- Patients having urinary tract infection or bladder outlet obstruction.
- Patients having neurological diseases.
- Patients having gynecological problems as genital infection, pelvic organ prolapse or genital tumors.
- Patients with electronic implants such as heart pacemakers.
- During pregnancy
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 |
|---|---|---|
| TPTNS+Drugone tablet Trospium Chloride 20 mg once daily Plus TPTNS | Combination product | TPTNS+Drug |
| TPTNSSurface adhesive electrodes placed on the skin above medial malleolus | Device | TPTNS |
Primary outcome
Patient satisfaction
Time frame: 1 year
Improvement in the questionnaire scores and associated willingness of the patient to continue treatment
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 7 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TPTNS+Drug and TPTNS in people with Overactive Bladder, run by Alexandria University.
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 6 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient satisfaction (time frame: 1 year). 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 7 Apr 2017.