Urinary RetentionNCT02547155
Does Spinal Anesthesia for Prolapse Surgery With Lead to Urinary Retention?
A study testing Spinal anesthesia and General anesthesia in people with Urinary Retention and Uterine Prolapse, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention, Uterine Prolapse
- What is being tested?
- Spinal anesthesia and General anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women over the age of 40
- Women scheduled for pelvic organ prolapse surgery as well as concomitant incontinence sling surgery
- Post-void residual <150 cc prior to surgery
- Surgery length of at least 1 hour
- BMI <40
- ASA class 1-2
Who cannot join
- Contraindications to surgery
- 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.
- BMI >40
- ASA class 3 or 4 that would be a contraindiction to both spinal or general anesthesia
- Evidence of voiding dysfunction or urinary retention on pre-operative urodynamics, including PVR >150, or dyssynergic sphincter dyssynergia
- Neurological diseases that can interfere with spinal anesthesia
Show all 9Show fewer
- Anticoagulation therapy within a week of surgery
- History of back surgery that would prevent successful spinal anesthesia
- History of back deformity, such as scoliosis that would prevent successful spinal anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Laura Martin, MD, 954-659-5559, martinl4@ccf.org
Laura Martin, MD
About this study
Official title: Does Spinal Anesthesia for Prolapse Surgery With Concomitant Sling Procedures Lead to an Increase in Urinary Retention Compared to General Anesthesia?
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.
Read the detailed 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.
- Conditions
- Urinary Retention, Uterine Prolapse
- Being tested
- Spinal anesthesia, General anesthesia
- Medical subject headings
- Urinary Retention, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
8-12.5 mg of bupivacaine will be administered for spinal anesthesia
General anesthesiaProcedure or surgery
propofol induction, in combination with a muscle relaxant and inhalational gas
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Experimental | Subjects randomized to spinal anesthesia will receive Bupivacaine 0.75%, 8-12.5 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. Receives: Procedure: Spinal anesthesia |
| General anesthesia | Active comparator | Subjects randomized to general anesthesia will receive propofol induction, in combination with a muscle relaxant and inhalational gas per anesthesia standard of care at our institution Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative urinary retention
bladder emptying completeness after surgery
Measured: within the first week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Martin, The Cleveland Clinic
- Investigators
- Laura Martin, DO, Principal investigator, Clevland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547155
- Sponsor's protocol ID
- FLA 15-019
- Status last verified
- Apr 2017
- First submitted
- 15 Jul 2015
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alas A, Martin L, Devakumar H, Frank L, Vaish S, Chandrasekaran N, Davila GW, Hurtado E. Anesthetics' role in postoperative urinary retention after pelvic organ prolapse surgery with concomitant midurethral slings: a randomized clinical trial. Int Urogynecol J. 2020 Jan;31(1):205-213. doi: 10.1007/s00192-019-03917-w. Epub 2019 Mar 23.
PubMed 30904934
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Spinal Anesthesia for Prolapse Surgery With Concomitant Sling Procedures Lead to an Increase in Urinary Retention Compared to General Anesthesia?
- ClinicalTrials.gov ID
- NCT02547155
- Acronym / sponsor ID
- FLA 15-019
- Conditions
- Urinary Retention, Uterine Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | Experimental | Procedure: Spinal anesthesiaSubjects randomized to spinal anesthesia will receive Bupivacaine 0.75%, 8-12.5 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. |
| General anesthesia | Active comparator | Procedure: General anesthesiaSubjects randomized to general anesthesia will receive propofol induction, in combination with a muscle relaxant and inhalational gas per anesthesia standard of care at our institution |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women over the age of 40
- Women scheduled for pelvic organ prolapse surgery as well as concomitant incontinence sling surgery
- Post-void residual <150 cc prior to surgery
- Surgery length of at least 1 hour
- BMI <40
Key exclusion criteria (9 listed)
- Contraindications to surgery
- 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.
- BMI >40
- ASA class 3 or 4 that would be a contraindiction to both spinal or general anesthesia
- Evidence of voiding dysfunction or urinary retention on pre-operative urodynamics, including PVR >150, or dyssynergic sphincter dyssynergia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesia8-12.5 mg of bupivacaine will be administered for spinal anesthesia | Procedure or surgery | Spinal anesthesia |
| General anesthesiapropofol induction, in combination with a muscle relaxant and inhalational gas | Procedure or surgery | General anesthesia |
Primary outcome
Incidence of postoperative urinary retention
Time frame: within the first week after surgery
bladder emptying completeness after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Derived from this study: PubMed 30904934Alas A, Martin L, Devakumar H, Frank L, Vaish S, Chandrasekaran N, Davila GW, Hurtado E. Anesthetics' role in postoperative urinary retention after pelvic organ prolapse surgery with concomitant midurethral slings: a randomized clinical trial. Int Urogynecol J. 2020 Jan;31(1):205-213. doi: 10.1007/s00192-019-03917-w. Epub 2019 Mar 23.
- Individual participant dataSharing planned: No
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Martin, DO principal investigator
Clevland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia and General anesthesia in people with Urinary Retention and Uterine Prolapse, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Maritn, DO (954-659-5559, martinl4@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative urinary retention (time frame: within the first week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02547155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017; AzTrials last refreshed its copy on 29 Oct 2026.