PTNS vs Botox of Refractory OAB

Overactive Bladder (OAB) Clinical Trial

— TROOP  

Official title:

Treatment of Refractory Overactive Bladder (OAB) With OnabotulinumtoxinA vs. PTNS: TROOP Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04451382
• Other study ID #: 2014-277
• Status: Terminated
• Start date: March 2015
• Est. completion date: December 2018

Study information

• Verified date: June 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Biological:
• OnabotulinumtoxinA (BoNTA)

Procedure:
• Percutaneous tibial nerve stimulation (PTNS)

Locations

Country	Name	City	State
United States	Columbia University	New York	New York
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Columbia University, Methodist Urology Associates, Houston, Texas, University of Michigan, University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 month
Primary	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.	3 month
Secondary	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.	3
Secondary	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	3