Does Spinal Anesthesia for Prolapse Surgery With Lead to Urinary Retention?

Urinary Retention Clinical Trial

Official title:

Does Spinal Anesthesia for Prolapse Surgery With Concomitant Sling Procedures Lead to an Increase in Urinary Retention Compared to General Anesthesia?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02547155
• Other study ID #: FLA 15-019
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2015
• Last updated: April 19, 2017
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: Laura Maritn, DO
• Phone: 954-659-5559
• Email: martinl4[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the risk of being unable to urinate shortly after surgery, also called acute post-operative urinary retention (POUR) between spinal and general anesthesia in women who undergo outpatient pelvic organ prolapse with stress urinary incontinence surgery.

Description:

A randomized trial to compare urinary retention rates between spinal and general anesthesia in women who undergo outpatient pelvic organ prolapse surgery with concomitant incontinence surgery.

Randomization

Randomization will be done in the pre-operative area, on the day of surgery. Computer generated randomization will be done in blocks of 4. Sealed numbered envelopes will be opened prior to surgery and the subject will then be assigned to spinal or general anesthesia. Patient randomization on day of surgery was discussed with anesthesia and it thought that randomizing on the same day would be safe.

Preoperatively

Subjects will be asked to complete a validated questionnaire, the Quality of Recovery 15 (QoR-15) prior to surgery, at their preoperative visit.

Anesthesia

Subjects randomized to general anesthesia will receive propofol induction, in combination with a muscle relaxant and inhalational gas per anesthesia standard of care at the investigators' institution.

Subjects randomized to spinal anesthesia will receive Bupivacaine 0.75%, 8-12 mg dose depending on estimated duration of surgery and anesthesiologist decision. In addition to spinal anesthesia, these subjects will possibly have concurrent administration of fentanyl, midazolam, and propofol so that they are mildy sedated or sleeping.

Voiding Trial

A voiding trial will be performed in the PACU once the subjects are able to stand and ambulate to the bathroom. Voiding trial will consist of removing the vaginal packing and back filling the bladder with 300cc of saline or less if subject has urgency or a smaller bladder capacity. A voiding trial is considered successful if the subject voids at least 2/3 of the total volume instilled and has a bladder scan showing less than 1/3 remaining. If a subject is unable to void after an hour, an additional hour will be permitted. However, after 2 hours from when the bladder was backfilled the subject is still unable to void, the Foley will be replaced and the subjects will be discharged home with a Foley leg bag and leg bag teaching.

An office nurse will call the subject and schedule an office nurse visit to remove the Foley between post-operative day number 5 to 7. If the subject goes home with a Foley this will be considered acute POUR.

Follow Up

Subjects will receive a phone call from either a nurse or fellow, between 48 to 72 hours post-operatively to make sure they are having no symptoms of urinary retention, are doing well and are not having any complications. A telephone survey will be administered during this follow up phone call using a validated questionnaire, the QoR-15. They will have received a copy of this survey to refer to at the time of their hospital discharge.

Subjects who were admitted to the hospital will have the same follow up, including a phone call 48 to 72 hours after their surgery, including the validated questionnaire, the QoR-15.

In addition, subjects will have a 6 week follow up visit in the clinic and will be asked to complete the QoR-15.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Women over the age of 40

2. Women scheduled for pelvic organ prolapse surgery as well as concomitant incontinence sling surgery

3. Post-void residual <150 cc prior to surgery

4. Surgery length of at least 1 hour

5. BMI <40

6. ASA class 1-2

Exclusion Criteria:

1. Contraindications to surgery

2. Contraindications to outpatient surgery, and requiring inpatient stay for medical comorbidities. The decision for a required inpatient stay will be decided prior to surgery based on the recommendations of the patient's primary care physician or specialist, such as cardiology or pulmonology.

3. BMI >40

4. ASA class 3 or 4 that would be a contraindiction to both spinal or general anesthesia

5. Evidence of voiding dysfunction or urinary retention on pre-operative urodynamics, including PVR >150, or dyssynergic sphincter dyssynergia

6. Neurological diseases that can interfere with spinal anesthesia

7. Anticoagulation therapy within a week of surgery

8. History of back surgery that would prevent successful spinal anesthesia

9. History of back deformity, such as scoliosis that would prevent successful spinal anesthesia

Related Conditions & MeSH terms

• Prolapse
• Urinary Retention
• Uterine Prolapse

Intervention

Procedure:
• Spinal anesthesia
8-12.5 mg of bupivacaine will be administered for spinal anesthesia
• General anesthesia
propofol induction, in combination with a muscle relaxant and inhalational gas

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative urinary retention	bladder emptying completeness after surgery	within the first week after surgery