Overactive Bladder (OAB)TROOPNCT04451382
PTNS vs Botox of Refractory OAB
An observational study of Overactive Bladder (OAB), run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection or percutaneous… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- OnabotulinumtoxinA (BoNTA) and Percutaneous tibial nerve stimulation (PTNS)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2015to Dec 2018
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with refractory OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (antimuscarinics or mirabegron), and have chosen either BTX or PTNS as their next treatment.
Who may be able to join
- Women with refractory OAB (dry or wet)
- OAB will be defined by a positive response and bother of "somewhat, quite a bit, a great deal, or a very great deal" to question #3 or #8 on the OAB-q (see appendix B) regarding urinary urgency and urgency incontinence.
- Refractory will be defined as failure of 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and OAB medication (anticholinergics or mirabegron). Trial of 2 medications that did not improve symptoms after 2 weeks or could not be tolerated due to side effects will constitute 2 treatment failures.
- Women with mixed urinary incontinence that is urge predominant will also be included.
- Age ≥ 18 years
- English speaking
- Available for 1 year follow-up
- Able to complete study questionnaires
Who cannot join
- Neurologic disease known to cause OAB including, but not limited to, Multiple sclerosis, Parkinson's disease, and Spinal Cord Injury.
- Pregnancy by self-report or pregnancy test
- Contraindication to PTNS and/or BTX
- PTNS: Pacemaker
- BTX: myasthenia gravis, allergy to BTX, urinary retention (post void residual >200cc)
- Planned surgery for pelvic floor disorder during the study period
- Prior treatment with BTX, PTNS, or sacral nerve stimulation (SNS) for refractory OAB/urinary urge incontinence (UUI)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University
New York, New York, 10032
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Treatment of Refractory Overactive Bladder (OAB) With OnabotulinumtoxinA vs. PTNS: TROOP Trial
This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their next treatment. OAB-dry refers to patients with OAB who do not have urge urinary incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible patients will be approached for study participation after they have decided to proceed with BTX or PTNS.
Read the detailed description
Prior to initiation of BTX or PTNS, patients will undergo a standardized evaluation including urodynamics study (UDS) if not previously done in the past year and pelvic organ prolapse quantification (POPq) exam if not previously done in past 6 months. Subjects will also complete quality of life questionnaires and 3-day voiding diary prior to initial treatment. Follow up questionnaires will be completed at 3 months either in office, if patient has a routine visit scheduled with provider and questionnaires can be completed at that visit or questionnaires will be mailed with return postage for participant to mail completed questionnaires back.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- OnabotulinumtoxinA (BoNTA), Percutaneous tibial nerve stimulation (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.
OnabotulinumtoxinA (BoNTA)Biological
Also called Botox
Percutaneous tibial nerve stimulation (PTNS)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA (BoNTA) | DRUG: OnabotulinumtoxinA (BoNTA) is an injection into the bladder which blocks the presynaptic release of acetylcholine. BoNTA was approved for the treatment of OAB by the FDA in 2013. Receives: Biological: OnabotulinumtoxinA (BoNTA) | |
| Percutaneous tibial nerve stimulation (PTNS) | DEVICE: PTNS involves needle stimulation of the posterior tibial nerve and is typically performed with weekly 30 minute sessions for a 12 week treatment course. Receives: Procedure: Percutaneous tibial nerve stimulation (PTNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in patient global impression of improvement score between PTNS and BTX groups
The Patient Global Impression of Improvement (PGI-I) is a single question that asks a patient to rate her urinary symptom response to treatment on a 7-point Likert scaleis a validated questionnaire for assessment of the impact of OAB on patient's lives.
Measured: 3 month
Change in quality of life between PTNS and BTX groups
The minimally important difference (MID) for change in SSS is 10 points. We compare the change in SS score between the PTNS and Botox groups at 3 months.
Measured: 3 month
Secondary outcomes (2)
Change in individual question scores on OAB-q questionnaire
The OAB-q consists of 33 items: an 8-item symptom bother scale (SS) and a 25-item health-related quality of life (HRQL) scale. Higher scores on HRQL scale represent better quality of life and lower scores on SSS is indicative of less bother.
Measured: 3
Change in urinary symptom severity
Tools used: Urogenital Distress Inventory short form (UDI-6) is a validated questionnaires used to assess urinary symptoms. We will compare change in scores between the 2 groups
Measured: 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study startMar 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Methodist Urology Associates, Houston, Texas, Columbia University, University of New Mexico
- Responsible party
- Principal investigator, Robert Gutman, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451382
- Sponsor's protocol ID
- 2014-277
- Acronym
- TROOP
- Status last verified
- Jun 2020
- First submitted
- 31 Oct 2015
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Refractory Overactive Bladder (OAB) With OnabotulinumtoxinA vs. PTNS: TROOP Trial
- ClinicalTrials.gov ID
- NCT04451382
- Acronym / sponsor ID
- TROOP / 2014-277
- Conditions
- Overactive Bladder (OAB)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- University of Michigan, Methodist Urology Associates, Houston, Texas, Columbia University, University of New Mexico
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Jun 2020 (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 is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their next treatment. OAB-dry refers to patients with OAB who do not have urge urinary incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible patients will be approached for study participation after they have decided to proceed with BTX or PTNS.
Detailed description
Prior to initiation of BTX or PTNS, patients will undergo a standardized evaluation including urodynamics study (UDS) if not previously done in the past year and pelvic organ prolapse quantification (POPq) exam if not previously done in past 6 months. Subjects will also complete quality of life questionnaires and 3-day voiding diary prior to initial treatment. Follow up questionnaires will be completed at 3 months either in office, if patient has a routine visit scheduled with provider and questionnaires can be completed at that visit or questionnaires will be mailed with return postage for participant to mail completed questionnaires back.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA (BoNTA) | – | Biological: OnabotulinumtoxinA (BoNTA)DRUG: OnabotulinumtoxinA (BoNTA) is an injection into the bladder which blocks the presynaptic release of acetylcholine. BoNTA was approved for the treatment of OAB by the FDA in 2013. |
| Percutaneous tibial nerve stimulation (PTNS) | – | Procedure: Percutaneous tibial nerve stimulation (PTNS)DEVICE: PTNS involves needle stimulation of the posterior tibial nerve and is typically performed with weekly 30 minute sessions for a 12 week treatment course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with refractory OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (antimuscarinics or mirabegron), and have chosen either BTX or PTNS as their next treatment.
Key inclusion criteria (8 listed)
- Women with refractory OAB (dry or wet)
- OAB will be defined by a positive response and bother of "somewhat, quite a bit, a great deal, or a very great deal" to question #3 or #8 on the OAB-q (see appendix B) regarding urinary urgency and urgency incontinence.
- Refractory will be defined as failure of 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and OAB medication (anticholinergics or mirabegron). Trial of 2 medications that did not improve symptoms after 2 weeks or could not be tolerated due to side effects will constitute 2 treatment failures.
- Women with mixed urinary incontinence that is urge predominant will also be included.
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- Neurologic disease known to cause OAB including, but not limited to, Multiple sclerosis, Parkinson's disease, and Spinal Cord Injury.
- Pregnancy by self-report or pregnancy test
- Contraindication to PTNS and/or BTX
- Planned surgery for pelvic floor disorder during the study period
- Prior treatment with BTX, PTNS, or sacral nerve stimulation (SNS) for refractory OAB/urinary urge incontinence (UUI)
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 |
|---|---|---|
| OnabotulinumtoxinA (BoNTA)Also: Botox | Biological | OnabotulinumtoxinA (BoNTA) |
| Percutaneous tibial nerve stimulation (PTNS) | Procedure or surgery | Percutaneous tibial nerve stimulation (PTNS) |
Primary outcome
Difference in patient global impression of improvement score between PTNS and BTX groups
Time frame: 3 month
The Patient Global Impression of Improvement (PGI-I) is a single question that asks a patient to rate her urinary symptom response to treatment on a 7-point Likert scaleis a validated questionnaire for assessment of the impact of OAB on patient's lives.
Change in quality of life between PTNS and BTX groups
Time frame: 3 month
The minimally important difference (MID) for change in SSS is 10 points. We compare the change in SS score between the PTNS and Botox groups at 3 months.
2 secondary outcomes
Change in individual question scores on OAB-q questionnaire
Time frame: 3
Change in urinary symptom severity
Time frame: 3
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder (OAB), run by Medstar Health Research Institute at 2 sites in United States.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Difference in patient global impression of improvement score between PTNS and BTX groups (time frame: 3 month). 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 30 Jun 2020.