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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04451382
Other study ID # 2014-277
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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