Stress IncontinencePhase 4NCT00734968
Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
A Phase 4 study testing Nitrofurantoin in people with Stress Incontinence, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence. 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 Incontinence
- What is being tested?
- Nitrofurantoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence
Who cannot join
- Exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).
Trial locations and contacts
1 site in 1 country.
United States1 site
Scott and White Hosptial, Texas A&M University
Temple, Texas, 76508
About this study
Official title: Does Prophylaxis With Macrobid Reduce the Incidence of Urinary Tract Infection in Patients Who Receive a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: Randomized, Double Blinded Placebo Controlled Clinical Trial
This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.
Read the detailed description
This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.
- Conditions
- Stress Incontinence
- Being tested
- Nitrofurantoin, Placebo
- Keywords
- Urinary tract infection (UTI), suburethral sling, Prevention, Nitrofurantoin, Prophylaxis
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrofurantoinDrug
Also called Macrobid
Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence
PlaceboOther
6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively Receives: Drug: Nitrofurantoin |
| Placebo | Placebo comparator | Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence
The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)
Measured: 6 weeks
Incidence of Post-operative UTI in Placebo Group
The incidence of UTI in the placebo group was 32%.
Measured: 6 weeks
Incidence of Post-operative UTI in Treatment Group
The incidence of UTI in the nitrofurantoin group was 17.6%.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Daniel L Jackson, M.D., Principal investigator, University of Missouri-ColumbiaRaymond T Foster, MD, MS, MHSc, Study director, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734968
- Sponsor's protocol ID
- 1108717
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2008
- Last updated
- 11 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Anger JT, Litwin MS, Wang Q, Pashos CL, Rodriguez LV. Complications of sling surgery among female Medicare beneficiaries. Obstet Gynecol. 2007 Mar;109(3):707-14. doi: 10.1097/01.AOG.0000255975.24668.f2.
PubMed 17329524Bent S, Nallamothu BK, Simel DL, Fihn SD, Saint S. Does this woman have an acute uncomplicated urinary tract infection? JAMA. 2002 May 22-29;287(20):2701-10. doi: 10.1001/jama.287.20.2701.
PubMed 12020306Aubin C. Evidence-based emergency medicine/rational clinical examination abstract. Does this woman have an acute uncomplicated urinary tract infection? Ann Emerg Med. 2007 Jan;49(1):106-8. doi: 10.1016/j.annemergmed.2006.09.022. No abstract available.
PubMed 17203544Bodelsson G, Henriksson L, Osser S, Stjernquist M. Short term complications of the tension free vaginal tape operation for stress urinary incontinence in women. BJOG. 2002 May;109(5):566-9. doi: 10.1111/j.1471-0528.2002.01195.x.
PubMed 12066948Ferro A, Byck D, Gallup D. Intraoperative and postoperative morbidity associated with cystoscopy performed in patients undergoing gynecologic surgery. Am J Obstet Gynecol. 2003 Aug;189(2):354-7; discussion 357. doi: 10.1067/s0002-9378(03)00677-x.
PubMed 14520192Grover ML, Bracamonte JD, Kanodia AK, Bryan MJ, Donahue SP, Warner AM, Edwards FD, Weaver AL. Assessing adherence to evidence-based guidelines for the diagnosis and management of uncomplicated urinary tract infection. Mayo Clin Proc. 2007 Feb;82(2):181-5. doi: 10.4065/82.2.181.
PubMed 17290725Gupta K, Hooton TM, Roberts PL, Stamm WE. Patient-initiated treatment of uncomplicated recurrent urinary tract infections in young women. Ann Intern Med. 2001 Jul 3;135(1):9-16. doi: 10.7326/0003-4819-135-1-200107030-00004.
PubMed 11434727Karram MM, Segal JL, Vassallo BJ, Kleeman SD. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol. 2003 May;101(5 Pt 1):929-32. doi: 10.1016/s0029-7844(03)00122-4.
PubMed 12738152Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7. doi: 10.1034/j.1600-0412.2002.810113.x.
PubMed 11942891LaSala CA, Schimpf MO, Udoh E, O'Sullivan DM, Tulikangas P. Outcome of tension-free vaginal tape procedure when complicated by intraoperative cystotomy. Am J Obstet Gynecol. 2006 Dec;195(6):1857-61. doi: 10.1016/j.ajog.2006.06.060.
PubMed 17132487Lim JL, Quinlan DJ. Safety of a new transobturator suburethral synthetic sling (TVT-O) procedure during the training phase. J Obstet Gynaecol Can. 2006 Mar;28(3):214-217. doi: 10.1016/S1701-2163(16)32111-9.
PubMed 16650360Pugsley H, Barbrook C, Mayne CJ, Tincello DG. Morbidity of incontinence surgery in women over 70 years old: a retrospective cohort study. BJOG. 2005 Jun;112(6):786-90. doi: 10.1111/j.1471-0528.2004.00522.x.
PubMed 15924538Schraffordt Koops SE, Bisseling TM, Heintz AP, Vervest HA. Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study. Am J Obstet Gynecol. 2005 Jul;193(1):45-52. doi: 10.1016/j.ajog.2004.11.004.
PubMed 16021057Sokol AI, Jelovsek JE, Walters MD, Paraiso MF, Barber MD. Incidence and predictors of prolonged urinary retention after TVT with and without concurrent prolapse surgery. Am J Obstet Gynecol. 2005 May;192(5):1537-43. doi: 10.1016/j.ajog.2004.10.623.
PubMed 15902154Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA; Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol. 2001 Nov;98(5 Pt 1):732-6. doi: 10.1016/s0029-7844(01)01565-4.
PubMed 11704161
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Prophylaxis With Macrobid Reduce the Incidence of Urinary Tract Infection in Patients Who Receive a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: Randomized, Double Blinded Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00734968
- Acronym / sponsor ID
- 1108717
- Conditions
- Stress Incontinence
- Keywords
- Urinary tract infection (UTI), suburethral sling, Prevention, Nitrofurantoin, Prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Texas A&M University
- Study start
- May 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 11 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.
Detailed description
This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: NitrofurantoinPatients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively |
| Placebo | Placebo comparator | Other: PlaceboArm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1) |
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 over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence
Key exclusion criteria (1 listed)
- Exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).
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 |
|---|---|---|
| NitrofurantoinAlso: MacrobidNitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence | Drug | Treatment |
| Placebo6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets. | Other | Placebo |
Primary outcome
Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence
Time frame: 6 weeks
The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)
Incidence of Post-operative UTI in Placebo Group
Time frame: 6 weeks
The incidence of UTI in the placebo group was 32%.
Incidence of Post-operative UTI in Treatment Group
Time frame: 6 weeks
The incidence of UTI in the nitrofurantoin group was 17.6%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17329524Anger JT, Litwin MS, Wang Q, Pashos CL, Rodriguez LV. Complications of sling surgery among female Medicare beneficiaries. Obstet Gynecol. 2007 Mar;109(3):707-14. doi: 10.1097/01.AOG.0000255975.24668.f2.
- Background: PubMed 12020306Bent S, Nallamothu BK, Simel DL, Fihn SD, Saint S. Does this woman have an acute uncomplicated urinary tract infection? JAMA. 2002 May 22-29;287(20):2701-10. doi: 10.1001/jama.287.20.2701.
- Background: PubMed 17203544Aubin C. Evidence-based emergency medicine/rational clinical examination abstract. Does this woman have an acute uncomplicated urinary tract infection? Ann Emerg Med. 2007 Jan;49(1):106-8. doi: 10.1016/j.annemergmed.2006.09.022. No abstract available.
- Background: PubMed 12066948Bodelsson G, Henriksson L, Osser S, Stjernquist M. Short term complications of the tension free vaginal tape operation for stress urinary incontinence in women. BJOG. 2002 May;109(5):566-9. doi: 10.1111/j.1471-0528.2002.01195.x.
- Background: PubMed 14520192Ferro A, Byck D, Gallup D. Intraoperative and postoperative morbidity associated with cystoscopy performed in patients undergoing gynecologic surgery. Am J Obstet Gynecol. 2003 Aug;189(2):354-7; discussion 357. doi: 10.1067/s0002-9378(03)00677-x.
- Background: PubMed 17290725Grover ML, Bracamonte JD, Kanodia AK, Bryan MJ, Donahue SP, Warner AM, Edwards FD, Weaver AL. Assessing adherence to evidence-based guidelines for the diagnosis and management of uncomplicated urinary tract infection. Mayo Clin Proc. 2007 Feb;82(2):181-5. doi: 10.4065/82.2.181.
- Background: PubMed 11434727Gupta K, Hooton TM, Roberts PL, Stamm WE. Patient-initiated treatment of uncomplicated recurrent urinary tract infections in young women. Ann Intern Med. 2001 Jul 3;135(1):9-16. doi: 10.7326/0003-4819-135-1-200107030-00004.
- Background: PubMed 12738152Karram MM, Segal JL, Vassallo BJ, Kleeman SD. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol. 2003 May;101(5 Pt 1):929-32. doi: 10.1016/s0029-7844(03)00122-4.
- Background: PubMed 11942891Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7. doi: 10.1034/j.1600-0412.2002.810113.x.
- Background: PubMed 17132487LaSala CA, Schimpf MO, Udoh E, O'Sullivan DM, Tulikangas P. Outcome of tension-free vaginal tape procedure when complicated by intraoperative cystotomy. Am J Obstet Gynecol. 2006 Dec;195(6):1857-61. doi: 10.1016/j.ajog.2006.06.060.
- Background: PubMed 16650360Lim JL, Quinlan DJ. Safety of a new transobturator suburethral synthetic sling (TVT-O) procedure during the training phase. J Obstet Gynaecol Can. 2006 Mar;28(3):214-217. doi: 10.1016/S1701-2163(16)32111-9.
- Background: PubMed 15924538Pugsley H, Barbrook C, Mayne CJ, Tincello DG. Morbidity of incontinence surgery in women over 70 years old: a retrospective cohort study. BJOG. 2005 Jun;112(6):786-90. doi: 10.1111/j.1471-0528.2004.00522.x.
- Individual participant dataSharing planned: Undecided
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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.
Daniel L Jackson, M.D. principal investigator
University of Missouri-Columbia
Raymond T Foster, MD, MS, MHSc study director
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrofurantoin in people with Stress Incontinence, run by University of Missouri-Columbia 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 11 Oct 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT00734968, which also lists 20 linked publications.
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 11 Oct 2016.