AUS Implatation (Female) Consent

Informed Consent For Surgical Operation / Procedure

Procedure: Artificial Urinary Sphincter (AUS) Implantation Female

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

An inflatable artificial urinary sphincter consisting of:

• Urethral cuff
• Pressure-regulating balloon
• Control pump

is surgically implanted.

The cuff is placed around the bladder neck/proximal urethra, the balloon reservoir in the pelvis or abdomen, and the pump in the labium.

The device remains deactivated for several weeks to allow healing.

4. Benefits and Indications

The procedure may be performed for severe stress urinary incontinence due to intrinsic sphincter deficiency that has not responded to conservative measures or previous surgical treatment.

The intended benefit is:

• Significant improvement or resolution of stress urinary incontinence
• Improved quality of life
• Reduced dependence on pads

Complete continence cannot be guaranteed.

5. Risks and Complications

• Common:
  • Pain
  • Bleeding
  • UTI
  • Wound infection
  • Temporary urinary retention and catheter discomfort.
• Less Common:
  • Device infection
  • Mechanical failure
  • Urethral atrophy
  • Persistent incontinence
  • Voiding difficulty
  • Need for intermittent catheterization and revision surgery.
• Rare but Serious:
  • Urethral/bladder injury
  • Cuff erosion
  • Device extrusion
  • Adjacent organ injury
  • Thromboembolism
  • Anaesthetic complications
  • Device removal and death, extremely rarely.

6. Postoperative Course

I understand that:

• Hospital stay is usually 1–3 days.
• Temporary catheterization may be required. The device remains inactive until healing is complete, after which activation and patient training are performed.
• The device is usually activated 4–6 weeks after surgery. Lifelong follow-up is necessary.

7. Alternatives to Procedure

I have been informed of alternatives including:

• Pelvic floor muscle training
• Continence devices
• Bulking agent injections
• Midurethral or autologous fascial sling
• Bladder neck closure with urinary diversion in selected complex cases
• Absorbent pads or catheters

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: _________________________________________