PTNS vs Botox of Refractory OAB

NCT04451382 | Terminated

• 1 other identifier: 2014-277
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Overactive Bladder (OAB)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in individual question scores on OAB-q questionnaire

  3

• Change in urinary symptom severity

  3

Study Arms (2)

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.

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.

Procedure: Percutaneous tibial nerve stimulation (PTNS)

Interventions

OnabotulinumtoxinA (BoNTA) BIOLOGICAL

Also known as: Botox

OnabotulinumtoxinA (BoNTA)

Percutaneous tibial nerve stimulation (PTNS) PROCEDURE

Percutaneous tibial nerve stimulation (PTNS)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• University of Michigan: collaborator
• Methodist Urology Associates, Houston, Texas: collaborator
• Columbia University: collaborator
• University of New Mexico: collaborator

Study Sites (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2015
• First Posted: June 30, 2020
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

US (2)