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Reduction of Bladder Injection Pain With Belladonna Opiate Suppository (ROBIN)

Primary Purpose

Overactive Bladder, Urinary Urge Incontinence, Urinary Bladder, Neurogenic

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Onabotulinumtoxin A (BoNT)

belladonna

Morphine

Placebo

Active B&O suppository of belladonna

About this trial

This is an interventional prevention trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Met clinical criteria under outside care or during the Principal Investigator's routine standard of care for BoNT injection therapy
No contraindication to BoNT therapy as outlined by drug manufacturer guidelines
Participants have elected to have the BoNT injection therapy prior to being offered enrollment into the study for either overactive bladder (OAB), neurogenic detrusor overactivity (NDO), or refractory interstitial cystitis (IC)

Exclusion Criteria:

Currently pregnant
Currently nursing a baby
Anticipated geographic relocation within the first 3 months following treatment
Allergy to morphine, belladonna, or opiates
Patients will be excluded if participating in another research study
Individuals unable to provide informed consent or to complete two-week follow-up bladder testing (post-void residual) or data collection will also be excluded

Sites / Locations

Wichita Women's Pelvic Surgery Center at Associates in Women's Health
University of Kansas School of Medicine - Wichita

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active B&O suppository of belladonna

Placebo suppository

Arm Description

Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.

Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.

Outcomes

Primary Outcome Measures

Change in Bladder Injection Pain

The primary outcome will be calculated difference in numeric rating scale (NRS) pain score prior to procedure and midway through procedure. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain). Measure will be reported as the intraoperative pain score minus the preoperative pain score.

Secondary Outcome Measures

Pre-analgesia Pain Score

Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).

Post-operative Pain Score

Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).

Number of Participants Declining to Complete Procedure Due to Pain Intolerance

Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.

Postoperative Voiding Trial Results

Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.

Post Void Residual (PVR)

Distribution of patients with volume in ml of post-void residual urine obtained via catheter greater than 200 ml at 2-week follow-up appointment.

Number of Participants With Evidence of Infection or Positive Urine Culture

Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.

Participant Satisfaction With Pain Control

Measured using one question Likert scale. This will be a 4-level scale ranging from 'not at all satisfied,' 'slightly satisfied,' 'mostly satisfied,' and 'very much satisfied.'

Full Information

NCT ID

NCT02600715

First Posted

October 29, 2015

Last Updated

August 24, 2018

Sponsor

Edgar LeClaire, MD

1. Study Identification

Unique Protocol Identification Number

NCT02600715

Brief Title

Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

Acronym

ROBIN

Official Title

Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

June 26, 2017 (Actual)

Study Completion Date

June 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Edgar LeClaire, MD

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder, Urinary Urge Incontinence, Urinary Bladder, Neurogenic, Painful Bladder Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active B&O suppository of belladonna

Arm Type

Experimental

Arm Description

Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.

Arm Title

Placebo suppository

Arm Type

Placebo Comparator

Arm Description

Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.

Intervention Type

Drug

Intervention Name(s)

Onabotulinumtoxin A (BoNT)

Other Intervention Name(s)

Botox, Allergan

Intervention Type

Drug

Intervention Name(s)

belladonna

Intervention Description

Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.

Intervention Type

Drug

Intervention Name(s)

Morphine

Intervention Description

Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

matching placebo to B&O suppository

Intervention Type

Drug

Intervention Name(s)

Active B&O suppository of belladonna

Intervention Description

belladonna 16.2mg and morphine 7.5mg

Primary Outcome Measure Information:

Title

Change in Bladder Injection Pain

Description

Time Frame

Baseline and intraoperative

Secondary Outcome Measure Information:

Title

Pre-analgesia Pain Score

Description

Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).

Time Frame

Baseline

Title

Post-operative Pain Score

Description

Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).

Time Frame

Postoperative (within 10 minutes of the end of the BoNT procedure)

Title

Number of Participants Declining to Complete Procedure Due to Pain Intolerance

Description

Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.

Time Frame

Intraoperative

Title

Postoperative Voiding Trial Results

Description

Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.

Time Frame

Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure)

Title

Post Void Residual (PVR)

Description

Distribution of patients with volume in ml of post-void residual urine obtained via catheter greater than 200 ml at 2-week follow-up appointment.

Time Frame

2 Weeks

Title

Number of Participants With Evidence of Infection or Positive Urine Culture

Description

Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.

Time Frame

2 Weeks

Title

Participant Satisfaction With Pain Control

Description

Measured using one question Likert scale. This will be a 4-level scale ranging from 'not at all satisfied,' 'slightly satisfied,' 'mostly satisfied,' and 'very much satisfied.'

Time Frame

Postoperative (within 10 minutes of the end of the BoNT procedure)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Met clinical criteria under outside care or during the Principal Investigator's routine standard of care for BoNT injection therapy No contraindication to BoNT therapy as outlined by drug manufacturer guidelines Participants have elected to have the BoNT injection therapy prior to being offered enrollment into the study for either overactive bladder (OAB), neurogenic detrusor overactivity (NDO), or refractory interstitial cystitis (IC) Exclusion Criteria: Currently pregnant Currently nursing a baby Anticipated geographic relocation within the first 3 months following treatment Allergy to morphine, belladonna, or opiates Patients will be excluded if participating in another research study Individuals unable to provide informed consent or to complete two-week follow-up bladder testing (post-void residual) or data collection will also be excluded

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edgar LeClaire, MD, FACOG

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wichita Women's Pelvic Surgery Center at Associates in Women's Health

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

University of Kansas School of Medicine - Wichita

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

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