Stress Urinary IncontinencePUBSNCT03353714
The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
A study testing Pudendal block in people with Stress Urinary Incontinence, run by Michael Flynn at 1 site in United States.
Trial summary
To determine the effect of a bilateral pudendal block on voiding dysfunction following midurethral slings. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pudendal block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Jul 2019
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing a midurethral sling without concomitant procedures under general anesthesia
Who cannot join
- Unable to consent (lacking capacity)
- Under 18 years of age
- Pregnant women
- Prisoners
- Using intermittent self-catheterization preoperatively
- Neurological disease or spinal cord injury resulting in voiding dysfunction
Show all 10Show fewer
- Allergy to bupivacaine
- Diagnosis of chronic pain syndromes
- Daily use of narcotics
- Intra-operative bladder injury necessitating use of a prolonged indwelling Foley catheter
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts
Worcester, Massachusetts, 01605
About this study
To determine the effect of a bilateral pudendal block on voiding dysfunction following midurethral slings.
Read the detailed description
Midurethral slings (MUS) are commonly performed to treat stress urinary incontinence in women. One common complication is short-term postoperative voiding dysfunction. Approximately 20% of patients undergoing MUS have difficulty voiding in the immediate postoperative period and are discharged home with an indwelling bladder catheter. A pudendal block provides analgesia to the vulva, vagina, and perineum and is used in various fields, ranging from obstetrical indications to hemorrhoidectomies. The colorectal literature has demonstrated an improvement in postoperative voiding dysfunction with intraoperative bilateral pudendal blockade, presumably due to pain relief. However, only one study has explored the effect of a pudendal blockade on postoperative voiding in patients undergoing MUS. This was a small French case series of 9 patients, and it concluded that it was a safe procedure with good patient satisfaction. Given the scant literature evaluating voiding dysfunction following pudendal blocks in MUS, and the encouraging data from anorectal surgeries, we aim to study this effect via a randomized, placebo-controlled, double-blinded trial.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Pudendal block
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal blockOther
Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)
| Study group | Role | What they receive |
|---|---|---|
| Pudendal block with saline | Placebo comparator | Pudendal block with normal saline Receives: Other: Pudendal block |
| Pudendal block with bupivacaine | Active comparator | Pudendal block with bupivacaine Receives: Other: Pudendal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative voiding dysfunction
Postoperative void trial (discharge home with or without Foley catheter)
Measured: Prior to discharge home (within 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Oct 2017
- Primary completion15 Apr 2019
- Study completion1 Jul 2019
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 Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Flynn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Flynn, University of Massachusetts, Worcester
- Investigators
- Deepali Maheshwari, DO, Principal investigator, UMass Medical SchoolMichael K Flynn, MD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353714
- Sponsor's protocol ID
- H00013722
- Acronym
- PUBS
- Status last verified
- Oct 2019
- First submitted
- 4 Nov 2017
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article after de-identification.
Publications
Maheshwari D, Sierra T, Leung K, Hall C, Flynn M. Effect of Pudendal Blockade on Bladder Emptying After Midurethral Sling: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e465-e468. doi: 10.1097/SPV.0000000000000963.
PubMed 33009265
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
- ClinicalTrials.gov ID
- NCT03353714
- Acronym / sponsor ID
- PUBS / H00013722
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Michael FlynnUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 27 Nov 2017 (actual)
- 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.
To determine the effect of a bilateral pudendal block on voiding dysfunction following midurethral slings.
Detailed description
Midurethral slings (MUS) are commonly performed to treat stress urinary incontinence in women. One common complication is short-term postoperative voiding dysfunction. Approximately 20% of patients undergoing MUS have difficulty voiding in the immediate postoperative period and are discharged home with an indwelling bladder catheter. A pudendal block provides analgesia to the vulva, vagina, and perineum and is used in various fields, ranging from obstetrical indications to hemorrhoidectomies. The colorectal literature has demonstrated an improvement in postoperative voiding dysfunction with intraoperative bilateral pudendal blockade, presumably due to pain relief. However, only one study has explored the effect of a pudendal blockade on postoperative voiding in patients undergoing MUS. This was a small French case series of 9 patients, and it concluded that it was a safe procedure with good patient satisfaction. Given the scant literature evaluating voiding dysfunction following pudendal blocks in MUS, and the encouraging data from anorectal surgeries, we aim to study this effect via a randomized, placebo-controlled, double-blinded trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pudendal block with saline | Placebo comparator | Other: Pudendal blockPudendal block with normal saline |
| Pudendal block with bupivacaine | Active comparator | Other: Pudendal blockPudendal block with bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing a midurethral sling without concomitant procedures under general anesthesia
Key exclusion criteria (10 listed)
- Unable to consent (lacking capacity)
- Under 18 years of age
- Pregnant women
- Prisoners
- Using intermittent self-catheterization preoperatively
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 |
|---|---|---|
| Pudendal blockPudendal block with normal saline (for control group) and bupivacaine (for intervention group) | Other | Pudendal block with bupivacaine, Pudendal block with saline |
Primary outcome
Postoperative voiding dysfunction
Time frame: Prior to discharge home (within 24 hours)
Postoperative void trial (discharge home with or without Foley catheter)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Derived from this study: PubMed 33009265Maheshwari D, Sierra T, Leung K, Hall C, Flynn M. Effect of Pudendal Blockade on Bladder Emptying After Midurethral Sling: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e465-e468. doi: 10.1097/SPV.0000000000000963.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article after de-identification.
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
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.
Deepali Maheshwari, DO principal investigator
UMass Medical School
Michael K Flynn, MD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal block in people with Stress Urinary Incontinence, run by Michael Flynn 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 21 Oct 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative voiding dysfunction (time frame: Prior to discharge home (within 24 hours)). 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 NCT03353714, 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 21 Oct 2019.