Urethral Bulking Agent Injection Consent

Informed Consent For Surgical Operation / Procedure

Procedure: Endoscopic Urethral Bulking Agent 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

A biocompatible bulking material is injected endoscopically around the urethra or bladder neck using a cystoscope to improve urethral closure and reduce urinary leakage.

It is usually performed as a day-care procedure.

4. Benefits and Indications

The procedure may be performed for:

• Stress urinary incontinence
• Intrinsic sphincter deficiency
• Patients unsuitable for or preferring to avoid more invasive surgery

The intended benefits include:

• Reduction in stress urinary incontinence
• Improved bladder control
• Improved quality of life
• Minimally invasive treatment
• Short recovery period
• Potential to delay or avoid more invasive surgery

Complete cure cannot be guaranteed and repeat injections are commonly required.

5. Risks and Complications

• Common
  • Dysuria
  • Mild haematuria
  • UTI
  • Urgency/frequency
  • Injection-site discomfort.
• Less Common
  • Temporary retention
  • Inadequate improvement
  • Need for repeat injections
  • Migration/resorption and inflammatory reaction.
• Rare but Serious
  • Urethral/bladder injury
  • Abscess
  • Significant bleeding
  • Persistent retention
  • Incorrect tissue-plane injection
  • Anaesthetic complications.

6. Postoperative Course

I understand that:

• Hospital stay is generally several days.
• Mild burning during urination
• Small amount of blood in urine for 24–48 hours
• Temporary urgency/frequency
• Routine activities may usually be resumed within 24–48 hours
• Follow-up is essential

7. Alternatives to Procedure

I have been informed of alternatives including:

• Pelvic floor physiotherapy
• Lifestyle modification
• Continence pessary
• Midurethral sling
• Autologous pubovaginal sling
• Burch colposuspension
• Artificial urinary sphincter
• 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: _________________________________________