Sacral Neuromodulation Consent

Informed Consent For Surgical Operation / Procedure

Procedure: Sacral Neuromodulation

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

SNM is a staged procedure.

Stage I: Tined lead placement as a trial.

A lead is placed adjacent to the sacral, usually S3, nerve under imaging guidance.

If symptom improvement is satisfactory, Stage II involves implantation of an implantable pulse generator beneath the skin.

4. Benefits and Indications

The procedure may be performed for:

  • Refractory overactive bladder
  • Non-obstructive urinary retention
  • Selected neurogenic bladder
  • Faecal incontinence
  • Chronic pelvic dysfunction after failure of conservative treatment

The intended benefits include:

  • Reduced urgency
  • Reduced frequency
  • Reduced incontinence
  • Improved bladder emptying
  • Reduced catheterization where applicable
  • Improved quality of life

5. Risks and Complications

  • Common
    • Pain
    • Bruising
    • Swelling
    • Mild bleeding
    • Altered stimulation
  • Less Common
    • Infection
    • Lead migration
    • Device malfunction
    • Implant discomfort
    • Failure of improvement
    • Allergic reaction and need for reprogramming
  • Rare but Serious
    • Deep infection requiring device removal
    • Nerve injury
    • CSF leak
    • Major bleeding
    • Lead fracture
    • DVT/PE
    • Anaesthetic complications and revision surgery

6. Postoperative Course

I understand that:

  • Usually day-care or overnight stay.
  • Heavy lifting and excessive bending should be avoided for 6 weeks.
  • Regular programming and follow-up are essential.
  • Stage I is a test procedure; permanent implantation depends on successful response, defined in the source as >50% improvement.

7. Alternatives to Procedure

I have been informed of alternatives including:

  • Behavioural therapy
  • Pelvic floor physiotherapy
  • Medications
  • CIC
  • Intravesical botulinum toxin
  • PTNS Reconstructive surgery
  • 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: _________________________________________