Clinical trial NCT04451382: PTNS vs Botox of Refractory OAB
Official title: Treatment of Refractory Overactive Bladder (OAB) With OnabotulinumtoxinA vs. PTNS: TROOP Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Overactive Bladder (OAB)
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Methodist Urology Associates, Houston, Texas
name: Columbia University
name: University of New Mexico
First posted: 2020-06-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Women with refractory OAB (dry or wet)
2. 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.
3. 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.
4. Women with mixed urinary incontinence that is urge predominant will also be included.
5. Age ≥ 18 years
6. English speaking
7. Available for 1 year follow-up
8. Able to complete study questionnaires

Exclusion Criteria:

1. Neurologic disease known to cause OAB including, but not limited to, Multiple sclerosis, Parkinson's disease, and Spinal Cord Injury.
2. Pregnancy by self-report or pregnancy test
3. Contraindication to PTNS and/or BTX

   * PTNS: Pacemaker
   * BTX: myasthenia gravis, allergy to BTX, urinary retention (post void residual \>200cc)
4. Planned surgery for pelvic floor disorder during the study period
5. Prior treatment with BTX, PTNS, or sacral nerve stimulation (SNS) for refractory OAB/urinary urge incontinence (UUI)

Primary outcomes:
measure: Difference in patient global impression of improvement score between PTNS and BTX groups
timeFrame: 3 month
measure: Change in quality of life between PTNS and BTX groups
timeFrame: 3 month
Secondary outcomes:
measure: Change in individual question scores on OAB-q questionnaire
timeFrame: 3
measure: Change in urinary symptom severity
timeFrame: 3
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
References: