NCT05652036: BIND

Procedural Discomfort Related to Number of Intradetrusor Botox Injections

Completed Phase 4 Results posted Last updated 13 April 2025

What this trial tests

Phase 4 trial testing Intradetrusor Botox Injections in Overactive Bladder in 108 participants. Completed in 15 May 2023.

Timeline

7 July 2022

Primary endpoint
6 April 2023

15 May 2023

Quick facts

Lead sponsor	The Methodist Hospital Research Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	108
Start date	7 July 2022
Primary completion	6 April 2023
Estimated completion	15 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Intradetrusor Botox Injections — full drug profile →

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

The Methodist Hospital Research Institute

Who can join

18 and older, female only, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participant Discomfort Related to BTX-A Injection Primary · Immediately post-procedure (up to 45min after intradetrusor BTX-A injections)

Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups.

Group	Value	95% CI
5 mL Group	3.2	± 2.3
10 mL Group	3.6	± 2.1

Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF) Secondary · Prior to BTX-A injections and 30 days post-procedure

Efficacy will be evaluated using the Overactive Bladder Questionnaire Short-Form (OAB-q SF), a validated instrument designed to measure symptom bother (SB) and the impact of OAB on health-related quality of life (HRQL). This questionnaire is administered on the day of the procedure (baseline) and again 30 days post-procedure. Changes in SB and HRQL scores assess improvement in OAB symptoms following BTX-A treatment. The OAB-q SF includes 19 items divided into two subscales: a 6-item SB scale (Questions 1-6) and a 13-item HRQL scale (Questions 7-19). SB items are scored from 1 ("not at all") t

OAB-q SF (SB (mean difference))

Group	Value	95% CI
5 mL Group	-22.4	-93 – 73
10 mL Group	-38.1	-100 – 60

OAB-q SF (HRQL (mean difference))

Group	Value	95% CI
5 mL Group	14.59	-59 – 60
10 mL Group	26.24	-30 – 71

Overall Treatment Satisfaction Secondary · 30 days post-procedure

Overall treatment satisfaction will be assessed at 30-days post-procedure via a "yes or no" response to inquiry about overall satisfaction with the procedure and results of their BTX-A treatment

Group	Value	95% CI
5ml/ 5 Injection	33
10ml/ 10 Injections	34
5ml/ 5 Injection	3
10ml/ 10 Injections	9

Impression of Clinical Improvement Secondary · 30 days post-procedure

Patients impression of clinical improvement after treatment will be assessed at 30-day post-procedure via the Clinical Global Impression - Improvement Scale (CGI-I). The CGI-I is a seven point verbal scale with higher values indicating higher impression of symptomatic improvement related to the treatment. Scale reports values as: Very much improved, Much improved, Minimally improved, No difference.

Very much improved

Group	Value	95% CI
5 mL Group	9
10 mL Group	9

Much improved

Group	Value	95% CI
5 mL Group	18
10 mL Group	16

Minimally improved

Group	Value	95% CI
5 mL Group	7
10 mL Group	15

No difference

Group	Value	95% CI
5 mL Group	2
10 mL Group	3

Procedural Outcomes Secondary · 30 days post-procedure

We will review the electronic medical record to evaluate instances of symptomatic urinary tract infection, bothersome incomplete bladder emptying requiring catheterization, and instances of bleeding requiring evaluation after the procedure.

Urinary retention

Group	Value	95% CI
5 mL Group	0
10 mL Group	2

Urinary tract infection

Group	Value	95% CI
5 mL Group	5
10 mL Group	2

Bleeding requiring evaluation

Group	Value	95% CI
5 mL Group	0
10 mL Group	0

Hematuria

Group	Value	95% CI
5 mL Group	1
10 mL Group	0

Bladder pain

Group	Value	95% CI
5 mL Group	0
10 mL Group	1

Emergency department evaluation

Group	Value	95% CI
5 mL Group	0
10 mL Group	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month post-treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

5 mL Group

Serious: 0/36 (0%)

Deaths: 0/36

10 mL Group

Serious: 0/43 (0%)

Deaths: 0/43

Other adverse events (6 terms — click to expand)

Reaction	System	5 mL Group	10 mL Group
Urinary Tract Infection	Renal and urinary disorders	—	—
Urinary Retention	Renal and urinary disorders	—	—
Emergency Department Evaluation	Renal and urinary disorders	—	—
Hematuria	Renal and urinary disorders	—	—
Bladder Pain	Renal and urinary disorders	—	—
Bleeding Requiring Evaluation	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT05652036 adverse events section.

Sponsor's own description

Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB. This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB. This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.