Urinary Tract InfectionsNCT03898310
UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
A study testing Cranberry extract capsules in people with Urinary Tract Infections and Incontinence, run by University of Oklahoma at 1 site in United States.
Trial summary
The risk of urinary tract infection (UTI) following female incontinence surgery ranges between 6-48%. The literature has shown mixed results of the therapeutic efficacy of cranberry extract to prevent UTI in females, with some promising preliminary work in the prevention of UTI's following gynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Tract Infections, Incontinence
- What is being tested?
- Cranberry extract capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2019to 22 Jan 2023
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing elective incontinence procedures that does not involve fistula repair or vaginal mesh excision
Who cannot join
- Women undergoing incontinence procedures involving fistula repair or vaginal mesh excision
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma
Oklahoma City, Oklahoma, 73104
About this study
The risk of urinary tract infection (UTI) following female incontinence surgery ranges between 6-48%. The literature has shown mixed results of the therapeutic efficacy of cranberry extract to prevent UTI in females, with some promising preliminary work in the prevention of UTI's following gynecologic surgery. The researchers will conduct a study of the effect of cranberry extracts on preventing urinary tract infections following mid urethral slings, which are the most common urinary incontinence procedures.
Read the detailed description
The researchers are going to perform a randomized, double-blind, placebo controlled trial of cranberry extract capsules for the prevention of UTI following incontinence surgery. They will recruit patients from a single hospital in a 24 month duration. Eligible participants are women undergoing elective incontinence procedures that does not involve fistula repair or vaginal mesh excision. The therapeutic regimen will be Theracran One cranberry capsules containing 36mg of proanthocyanidins and placebo cranberry capsules and placebo capsules. Both will be supplied by Theralogix Nutritional Sciences.
Following randomization into treatment or placebo therapy, the participants will be asked to start prophylaxis on day of surgery for a duration of six weeks. The researchers will collect urine specimen via catheter upon insertion in the operating room. At time of discharge, the researchers will provide all participants with capsules for six weeks of the assigned regimen until they are seen for their post-operative visit.
Participants will be told to contact research staff immediately and collect a urine specimen should they experience urinary symptoms consistent with UTI. The researchers will administer a brief structured interview regarding type and duration of symptoms and refer for treatment when necessary. Urine will be cultured using standard microbiologic techniques for the presence of uropathogens at one clinical laboratory.
Participants will be asked to complete a self-administered questionnaire at the two week post-operative clinic visit and again at six weeks. At study exit, the researchers will collect capsule bottles to ensure and assess compliance.
- Conditions
- Urinary Tract Infections, Incontinence
- Being tested
- Cranberry extract capsules, Placebo capsule
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry extract capsulesDietary supplement
Participants in the treatment arm will receive cranberry extract capsules.
Placebo capsuleDietary supplement
Participants in the placebo arm will receive placebo capsules.
| Study group | Role | What they receive |
|---|---|---|
| Cranberry Extract Capsules | Experimental | 36mg of proanthocyanidins in cranberry capsules Receives: Dietary Supplement: Cranberry extract capsules |
| Placebo Capsules | Placebo comparator | Not described Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine culture based on type of symptoms
A urine culture to determine UTI will be performed based on symptoms such as urgency, frequency, dysuria or hematuria following incontinence surgery, as reported by the participant.
Measured: 2 weeks
Secondary outcomes (1)
Duration of symptoms
If symptoms are reported, the participant will be asked long they have had these symptoms since surgery.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start5 Feb 2019
- Primary completion22 Jan 2023
- Study completion22 Jan 2023
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 Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieschen Quiroz, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898310
- Sponsor's protocol ID
- 9977
- Status last verified
- Jun 2023
- First submitted
- 27 Feb 2019
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Temtanakitpaisan T, Buppasiri P, Lumbiganon P, Laopaiboon M, Rattanakanokchai S. Prophylactic antibiotics for preventing infection after continence surgery in women with stress urinary incontinence. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD012457. doi: 10.1002/14651858.CD012457.pub2.
PubMed 35349162
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
- ClinicalTrials.gov ID
- NCT03898310
- Acronym / sponsor ID
- 9977
- Conditions
- Urinary Tract Infections, Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 22 Jan 2023 (actual)
- Study completion
- 22 Jan 2023 (actual)
- First posted
- 1 Apr 2019 (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.
The risk of urinary tract infection (UTI) following female incontinence surgery ranges between 6-48%. The literature has shown mixed results of the therapeutic efficacy of cranberry extract to prevent UTI in females, with some promising preliminary work in the prevention of UTI's following gynecologic surgery. The researchers will conduct a study of the effect of cranberry extracts on preventing urinary tract infections following mid urethral slings, which are the most common urinary incontinence procedures.
Detailed description
The researchers are going to perform a randomized, double-blind, placebo controlled trial of cranberry extract capsules for the prevention of UTI following incontinence surgery. They will recruit patients from a single hospital in a 24 month duration. Eligible participants are women undergoing elective incontinence procedures that does not involve fistula repair or vaginal mesh excision. The therapeutic regimen will be Theracran One cranberry capsules containing 36mg of proanthocyanidins and placebo cranberry capsules and placebo capsules. Both will be supplied by Theralogix Nutritional Sciences.
Following randomization into treatment or placebo therapy, the participants will be asked to start prophylaxis on day of surgery for a duration of six weeks. The researchers will collect urine specimen via catheter upon insertion in the operating room. At time of discharge, the researchers will provide all participants with capsules for six weeks of the assigned regimen until they are seen for their post-operative visit.
Participants will be told to contact research staff immediately and collect a urine specimen should they experience urinary symptoms consistent with UTI. The researchers will administer a brief structured interview regarding type and duration of symptoms and refer for treatment when necessary. Urine will be cultured using standard microbiologic techniques for the presence of uropathogens at one clinical laboratory.
Participants will be asked to complete a self-administered questionnaire at the two week post-operative clinic visit and again at six weeks. At study exit, the researchers will collect capsule bottles to ensure and assess compliance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry Extract Capsules | Experimental | Dietary Supplement: Cranberry extract capsules36mg of proanthocyanidins in cranberry capsules |
| Placebo Capsules | Placebo comparator | Dietary Supplement: Placebo capsule |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing elective incontinence procedures that does not involve fistula repair or vaginal mesh excision
Key exclusion criteria (1 listed)
- Women undergoing incontinence procedures involving fistula repair or vaginal mesh excision
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 |
|---|---|---|
| Cranberry extract capsulesParticipants in the treatment arm will receive cranberry extract capsules. | Dietary supplement | Cranberry Extract Capsules |
| Placebo capsuleParticipants in the placebo arm will receive placebo capsules. | Dietary supplement | Placebo Capsules |
Primary outcome
Urine culture based on type of symptoms
Time frame: 2 weeks
A urine culture to determine UTI will be performed based on symptoms such as urgency, frequency, dysuria or hematuria following incontinence surgery, as reported by the participant.
1 secondary outcome
Duration of symptoms
Time frame: 2 weeks
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 13 Jun 2023.
- Derived from this study: PubMed 35349162Temtanakitpaisan T, Buppasiri P, Lumbiganon P, Laopaiboon M, Rattanakanokchai S. Prophylactic antibiotics for preventing infection after continence surgery in women with stress urinary incontinence. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD012457. doi: 10.1002/14651858.CD012457.pub2.
- Individual participant dataSharing planned: No
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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.
Lieschen Quiroz, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry extract capsules in people with Urinary Tract Infections and Incontinence, run by University of Oklahoma 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 1 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 13 Jun 2023. 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?
Urine culture based on type of symptoms (time frame: 2 weeks). 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 NCT03898310, 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 13 Jun 2023.