Join the Youth organization of USI - The Fastest Growing Chapter of Urological Society of India. Fill out the form today!
Informed Consent For Surgical Operation / Procedure
Procedure: Intravesical Botulinum Toxin Injection
1. Patient Identification
I, ______________________________ (patient/next of kin/legal guardian), aged ____ years, in my full senses, voluntarily authorize and give my complete consent for performance of the following procedure(s)/operation(s)/treatment(s):
Procedure: _______________________________
Diagnosis: ________________________________
Major illness & comorbidities: ________________________________
2. Authorization for Procedure
I authorize Dr. __________________ to perform the above procedure, along with such assistants and associates as may be selected by him/her.
I understand that members of the surgical team, including residents or trainees under appropriate supervision, may perform parts of the procedure according to their training and competence.
3. Nature of Procedure
Using a cystoscope inserted through the urethra, multiple small injections of botulinum toxin are administered into the bladder wall.
The medication reduces involuntary bladder contractions and improves bladder storage.
4. Benefits and Indications
The procedure may be performed for:
- Overactive bladder
- Neurogenic detrusor overactivity
- Bladder symptoms inadequately controlled with behavioural measures and/or medications
- Neurogenic bladder dysfunction
The intended benefits include:
- Reduction in urgency
- Reduction in frequency
- Reduction in urgency urinary incontinence
- Increased bladder capacity
- Reduced bladder pressure in neurogenic bladder
- Improved quality of life
The treatment is temporary and usually lasts approximately 6–9 months.
5. Risks and Complications
- Common
- Mild burning
- Temporary blood in urine
- UTI
- Transient discomfort.
- Less Common
- Difficulty emptying the bladder
- Urinary retention requiring CIC
- Increased post-void residual urine
- Persistent symptoms.
- Rare but Serious
- Allergic reaction
- Generalized muscle weakness
- Spread of botulinum toxin effect
- Severe UTI/urosepsis
- Bladder injury
- Anaesthetic complications and death, extremely rarely.
6. Postoperative Course
I understand that:
- Day-care surgery or overnight admission may be required.
- Mild burning, urinary frequency or slight haematuria may occur for 24–48 hours. Adequate hydration and follow-up are advised.
- Catheter care
- Stoma care
- CIC training
- Regular follow-up
- The effect begins within 1–2 weeks, and repeat injections may be required.
7. Alternatives to Procedure
I have been informed of alternatives including:
- Lifestyle modification and bladder training
- Pelvic floor therapy
- Oral medications
- Sacral neuromodulation
- Augmentation cystoplasty
- Continued conservative management
8. Anaesthesia and Pain Management
I understand the risks associated with local, regional, or general anaesthesia.
Pain management options have been explained.
9. Photography / Data Use
I consent to:
☐ Medical photography/video for academic purposes
☐ Use of anonymized clinical data
10. Intraoperative Decision Consent
I authorize the surgeon to perform additional procedures considered necessary if unexpected findings arise during surgery.
11. Team-Based Care
I understand that supervised residents, fellows, or assistants may participate.
12. Patient Statement
I confirm that:
- The nature of surgery has been explained.
- Risks, benefits, and alternatives have been explained.
- My questions have been answered satisfactorily.
- I voluntarily consent.
Patient to write in own handwriting:
“I have understood the procedure, risks, benefits and alternatives explained to me in a language I understand.”
Signatures
Patient Name & Signature: ______________________________________
Date: ____________________ Time: ____________________
Doctor Name & Signature: ______________________________________
Date: ____________________ Time: ____________________
Witness Name & Signature: ____________________________________
Contact No.: ______________________________
ATTENDANT CONSENT (If applicable)
Reason patient unable to consent:
Attendant Name: __________________________________________
Relationship: _____________________________________________
Signature: ________________________________________________
Contact No.: ______________________________________________
INTERPRETER STATEMENT (If applicable)
I confirm an accurate explanation in understandable language.
Name: _________________________________________________
Signature: ______________________________________________
Contact: ________________________________________________
HIGH-RISK CONSENT (If applicable)
High-risk factors explained due to:
Patient Signature: ________________________________________
Doctor Signature: _________________________________________
