Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

NCT02369068 | Completed Results

• 1 other identifier: 2015-008
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare the effectiveness of two different medications used in intravaginal trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent).

Conditions

Pelvic Pain

Outcome Measures

Primary Outcomes (4)

• Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS).

  The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 1 month and the visual analog scale at baseline was calculated. Positive numbers indicate the pain increased from baseline to 1 month and negative numbers indicates that pain decreased.

  Baseline and One Month

• Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.

  Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores together and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 1 month and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased.

  Baseline and One Month

• Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.

  The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding scores from questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 1 month and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased.

  Baseline and One Month

• Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.

  The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Question 2 asks the subject to rate their pain symptoms since having TPI. Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).

  Baseline and One Month

Secondary Outcomes (8)

• Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.

  Baseline and Three Months

• Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.

  Baseline and Three Months

• Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.

  Baseline and Three months

• Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.

  Baseline and Three Months

• Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.

  Baseline and Six Months

Study Arms (2)

Onabotulinumtoxin A

EXPERIMENTAL

Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations. An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site).

Drug: Onabotulinumtoxin A

Kenalog

ACTIVE COMPARATOR

Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations. A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).

Drug: Kenalog

Interventions

Onabotulinumtoxin A DRUG

Intravaginal pelvic floor injection one series

Also known as: Botox

Onabotulinumtoxin A

Kenalog DRUG

Intravaginal pelvic floor injection one series

Also known as: triamcinolone

Kenalog

Eligibility Criteria

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

You may qualify if:

• Provide informed consent
• Healthy women \> age 18 regardless of menopausal status
• Willing and able to fill out study questionnaires. In patients that are unable to read, the research nurse will be available to assist.
• High-tone pelvic floor dysfunction on vaginal exam
• A pelvic pain score of \> 4 on screening Visual Analog Scale (VAS)
• Pain perceived to be in the pelvis that has been present for at least 3 months.

You may not qualify if:

• Patients that have had Botox to the bladder within the last 8 months
• Patients that have had Botox outside the bladder of \> 160 u within the last 12 weeks.
• Patients that have had transvaginal trigger point injections of any form (Botox or steroid) in the last 3 months
• Pregnancy
• Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the study period that could be deemed unsafe in combination with study medication as judged by the investigators.
• Any evidence of vaginitis on wet mount slide at initial visit that is untreated.
• Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
• Any indication/condition/medication that the investigators identify as contraindicated in conjunction with study medication.
• Systolic blood pressure \> 160 mm Hg on screening blood pressure
• Heart rate \> 110 beats/minute on screening heart rate

Sponsors & Collaborators

• Jamie Bartley, DO: lead

Study Sites (1)

Beaumont Hospitals

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Pelvic Pain

Interventions

Botulinum Toxins, Type A; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Pain; Neurologic 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; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Deborah Hasenau RN, Director, Urology Research
• Organization: Beaumont Hospital, Royal Oak

Deborah.Hasenau@Beaumont.org

248-551-0804

Study Officials

• Jamie Bartley, DO

  Beaumont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 23, 2015
• Study Start: August 1, 2015
• Primary Completion: March 26, 2018
• Study Completion: September 24, 2018
• Last Updated: July 24, 2019
• Results First Posted: February 6, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)