## Protocol Section
### Identification Module
**NCT ID:** NCT06437899

**Acronym:** LA vs SA

**Brief Title:** Evaluation of Efficacy and Patient Satisfaction of Local Anaesthesia Versus Sedoanalgesia for Botox (R) Injection in the Urinary Bladder for the Treatment of Idiopathic Overactive Bladder

**Official Title:** Evaluation of Efficacy and Patient Satisfaction Using Local Anaesthesia Versus Sedoanalgesia for Intradetrusor Botulinum-Toxin A Injection for the Treatment of Idiopathic Overactive Bladder: a Randomized Controlled Non-inferiority Trial

#### Organization Study ID Info
**ID:** 21346
#### Organization
**Class:** OTHER
**Full Name:** Hospital LKH Hochsteiermark - Leoben
#### Secondary ID Infos
**Domain:** AUB - Arbeitsgemeinschaft für Urogynäkologie Österreich
**ID:** AUB
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2026-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-03-30
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital LKH Hochsteiermark - Leoben

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Patients with symptoms of overactive bladder suffer from frequent micturition, urinary incontinence and recurrent urinary tract infections. Intravesical injections with botulinum toxin A can be used as a second-line therapy for this purpose.

Intravesical botulinum toxin A injections can be performed under general anesthesia, regional anesthesia, sedoanalgesia and local anesthesia. Which form of anesthesia is used varies greatly from region to region.

As these patients are often elderly and morbid, the lowest-risk and least stressful anesthesia method should be used. The lowest-risk anesthesia method that can be used is local anesthesia. Currently, there are no guidelines that describe the use of standardized protocols for local anesthesia.

The aim of this study is to show that the use of local anesthesia in this context is not inferior to the use of sedoanalgesia.

All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study.

The main outcome measure is pain, secondary outcome measures are quality of life, patient satisfaction, incontinence score, operation time and length of stay in the recovery room, acceptance of repeating the procedure under local anesthesia, satisfaction with the type of anesthesia method, side effects/complications and duration of inpatient stay.

The study will be randomized into 2 arms (local anesthesia/sedoanalgesia) with a 1:1 ratio to carry out the intravesical injection with botulinum toxin A.

**Detailed Description:** Urinary urgency symptoms with frequent micturition, urinary incontinence, nocturia and recurrent urinary tract infections are typical complaints of women with symptoms of an overactive bladder. The level of suffering is usually very high. Social withdrawal, depressive moods, frequent antibiotic use and financial burdens due to the increased need for incontinence products can be the result. In accordance with the guideline-based treatment of idiopathic overactive bladder, intravesical injection of botulinum toxin A can be offered after unsuccessful conservative first-line and second-line treatment. Intravesical injection of botulinum toxin A has been approved for the treatment of idiopathic overactive bladder in Austria since 2013. Botulinum toxin A is a registered drug in Austria and is used for injection into the detrusor with 100IE according to its approval indication.

Intravesical botulinum toxin A injections can be performed under general anesthesia, regional anesthesia, sedoanalgesia and local anesthesia. Which form of anesthesia is used varies greatly from region to region. The effectiveness of botulinum toxin A is limited in time. Injections are repeated on average after 6-12 months. Patients are often older and often have comorbidities. Due to this and the potential need for repeated applications, the procedure should be performed under general and regional anesthesia. The use of local anesthesia, as one of the anesthesia methods mentioned, is considered to be very low-risk and the least stressful overall.

Comparing the use of local anesthesia with the use of sedoanalgesia to perform the botulinum toxin A injection is equivalent to comparing two guideline-compliant standard treatments. The confirmation of our hypothesis, namely that performing the procedure under local anesthesia is equivalent to performing it under sedoanalgesia (non-inferiority study), could serve to optimize the treatment of overactive bladder patients and contribute to an increase in the level of health protection by strengthening the role of local anesthesia in the context of this procedure as an efficient option with the elimination of all anesthetic risks and as a first-choice procedure.

All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study.

The following examinations are carried out on all patients before inclusion, in accordance with the examination standard of our department:

* Medical history: age, micturition frequency day/night, urinary leakage, sexuality, amount drunk, frequency of urinary tract infections, previous treatments for incontinence, parity, secondary diseases (diabetes mellitus, obesity, arterial hypertension, central nervous diseases, etc), previous gynecological operations, medication
* Urogynecological examination
* Urinalysis (midstream urine)
* Urodynamics with stress test
* Micturition protocol (will be scanned)
* Standardized questionnaires to assess incontinence symptoms and quality of life

This is an open prospective randomized controlled non-inferiority study. Patients participating in the study will be randomized into 2 arms (local anesthesia/sedoanalgesia) with a 1:1 ratio. Randomization will be done electronically (www.randomizer.at).

The sample design was calculated based on a non-inferiority study with pain score evaluation as the primary endpoint.

A sample size of 39 per group, including expected drop-outs (approximately 3 per group) results in a required number of participants of 84.

### Conditions Module

**Conditions:**

- Overactive Bladder

**Keywords:**

- overactive bladder

- botulinum toxin A

- local anaesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 84

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: intravesical botulinum toxin A injection unter local anaesthesia

**Label:** local anaesthesia

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: intravesical botulinum toxin A injection unter local anaesthesia

**Label:** sedoanalagesia

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- local anaesthesia

- sedoanalagesia

**Description:** Arm1: Botulinum toxin A injection under local anesthesia according to standard protocol:

Retrograde filling of the empty urinary bladder with a 1:1 mixture of 50 ml lidocaine 1% mixed with 50 ml sodium bicarbonate 8.4%, leave the local anesthetic mixture in the bladder for 15 minutes.

Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10 ml NaCl 0.9% into the detrusor at 10 points using a rigid 70 degree cystoscope

Arm 2: botulinum toxin A injection in sedoanalgesia according to the anesthesia standard protocol:

Intravenous administration of remifentanil (0.05-0.15µg/kg/min) and propofol. Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10ml NaCl 0.9% into the detrusor.

**Name:** intravesical botulinum toxin A injection unter local anaesthesia

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The numeric rating scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and ten meaning "the worst pain imaginable".

**Measure:** pain assessed by numeric rating scale

**Time Frame:** twentyfour hours

#### Secondary Outcomes

**Description:** The postoperative anaesthesia questionnaire is a tool used to assess a patient's experience with anesthesia following surgery. It aims to gather information about the patient's perceptions of anesthesia-related outcomes and any adverse effects they may have experienced. It collects direct feedback from patients about their subjective experiences, including satisfaction and any discomfort or complications. Common sections and questions are about preoperative information, intraoperative experience, postoperative symptoms and overall satisfaction. Questions are answered with "yes" or "no".

**Measure:** patient satisfaction assessed with postoperative anaesthesia questionnaire

**Time Frame:** twentyfour hours

**Description:** The King's Health Questionnaire is a disease specific, self-administered questionnaire designed to assess the impact of urinary incontinence on quality of life in women. The questions in this questionnaire are to be answered using a 0-4 scale, with zero meaning "not applicable" and four meaning "very accurate".

**Measure:** quality of life assessed with King's Health Questionnaire

**Time Frame:** three and twelve months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Women with a minimum age of 18 years; no maximum age
* Unsuccessful conservative first and second-line treatment of OAB (defined as: completed pelvic floor/bladder training, local estrogenization of the vagina, at least one anticholinergic or ß3-mimetic oral therapy)
* Good German language skills

Exclusion Criteria:

* Pregnant women, breastfeeding women (no indication for approval)
* Women unable to give informed consent
* Refusal to participate in the study

**Gender Based:** True

**Gender Description:** All individuals with anatomical organs of a woman

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Leoben

**Country:** Austria

**Facility:** LKH Hochsteiermark

**Zip:** 8700

### IPD Sharing Statement Module

**Description:** The important and interesting data are published in a journal as part of the publication.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Subramanian B, Shastri N, Aziz L, Gopinath R, Karlekar A, Mehta Y, Sharma A, Bapat JS, Jain P, Jayant A, Samra T, Perera A, Agarwal A, Shetty V, Bhatnagar S, Pandya ST, Jain P. ASSIST - Patient satisfaction survey in postoperative pain management from Indian subcontinent. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):40-47. doi: 10.4103/joacp.JOACP_245_16.

**PMID:** 28413271

**Citation:** Smith I, Avramov MN, White PF. A comparison of propofol and remifentanil during monitored anesthesia care. J Clin Anesth. 1997 Mar;9(2):148-54. doi: 10.1016/S0952-8180(96)00240-1.

**PMID:** 9075041

**Citation:** Barba M, Lazar T, Cola A, Marino G, Manodoro S, Frigerio M. Learning Curve of Botulinum Toxin Bladder Injection for the Treatment of Refractory Overactive Bladder. Int J Womens Health. 2022 Jan 4;14:1-7. doi: 10.2147/IJWH.S345454. eCollection 2022.

**PMID:** 35018123

**Citation:** Schurch B, Reitz A, Tenti G. Electromotive drug administration of lidocaine to anesthetize the bladder before botulinum-A toxin injections into the detrusor. Spinal Cord. 2004 Jun;42(6):338-41. doi: 10.1038/sj.sc.3101593.

**PMID:** 15007374

**Citation:** Faure Walker N, Macpherson F, Tasleem A, Rampal T. Interventions to improve tolerability of local anesthetic intradetrusor Botulinum toxin injections: A systematic review. Neurourol Urodyn. 2023 Jan;42(1):23-32. doi: 10.1002/nau.25061. Epub 2022 Oct 23.

**PMID:** 36378811

**Citation:** Cox L, Cameron AP. OnabotulinumtoxinA for the treatment of overactive bladder. Res Rep Urol. 2014 Jul 21;6:79-89. doi: 10.2147/RRU.S43125. eCollection 2014.

**PMID:** 25157339

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001745

- Term: Urinary Bladder Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000059411

- Term: Lower Urinary Tract Symptoms

- ID: D000020924

- Term: Urological Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27167

- Name: Urinary Bladder, Overactive

- Relevance: HIGH

- As Found: Overactive Bladder

- ID: M5026

- Name: Urinary Bladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M29464

- Name: Lower Urinary Tract Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000053201

- Term: Urinary Bladder, Overactive

### Intervention Browse Module - Ancestors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000065087

- Term: Acetylcholine Release Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000009465

- Term: Neuromuscular Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: Analg

- Name: Analgesics

- Abbrev: VaDiAg

- Name: Vasodilator Agents

### Intervention Browse Module - Browse Leaves

- ID: M5183

- Name: Botulinum Toxins

- Relevance: HIGH

- As Found: Light

- ID: M21257

- Name: Botulinum Toxins, Type A

- Relevance: HIGH

- As Found: Neurocognitive

- ID: M250193

- Name: abobotulinumtoxinA

- Relevance: HIGH

- As Found: Neurocognitive

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

- ID: M18307

- Name: Propofol

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M1696

- Name: Remifentanil

- Relevance: LOW

- As Found: Unknown

- ID: M3473

- Name: Acetylcholine

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001905

- Term: Botulinum Toxins

- ID: D000019274

- Term: Botulinum Toxins, Type A

- ID: C000542869

- Term: abobotulinumtoxinA

### Misc Info Module

- Version Holder: 2024-05-31
