Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

NCT ID: NCT02369068

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-09-24

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).

Detailed Description

Chronic pelvic pain (CPP) is a common and often debilitating problem among women. The musculoskeletal system is an important factor in chronic pelvic pain. Studies have demonstrated that women with CPP had more frequent musculoskeletal findings. On physical examination, myofascial trigger points have been found. Trigger points are hyperirritable bands of muscle that can be felt from the vaginal wall. They are often knot-like or taut and are painful when pressure is placed on them. Intravaginal injections of these trigger points using steroids including Kenalog (triamcinolone) have been done and produced decreases in pelvic pain. Trigger point injections of Onabotulinumtoxin A has also been shown to decrease pain in subjects with CPP. This study will compare these two drugs and assess pain (using subject questionnaires) at one, three and six months post injection.

Conditions

Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Onabotulinumtoxin A

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).

Group Type: EXPERIMENTAL

Onabotulinumtoxin A

Intervention Type: DRUG

Intravaginal pelvic floor injection one series

Kenalog

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).

Group Type: ACTIVE_COMPARATOR

Kenalog

Intervention Type: DRUG

Intravaginal pelvic floor injection one series

Interventions

Onabotulinumtoxin A

Intravaginal pelvic floor injection one series

Intervention Type: DRUG

Kenalog

Intravaginal pelvic floor injection one series

Intervention Type: DRUG

Other Intervention Names

Botox; triamcinolone

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jamie Bartley, DO

OTHER

Sponsor Role: lead

Responsible Party

Jamie Bartley, DO

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jamie Bartley, DO

Role: PRINCIPAL_INVESTIGATOR

Beaumont

Locations

Beaumont Hospitals

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-008

Identifier Type: -

Identifier Source: org_study_id