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NCT00734968
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
Phase 4 trial testing Nitrofurantoin in Stress Incontinence in 161 participants. Completed in 1 May 2010.
1 May 2010
Quick facts
| Lead sponsor | University of Missouri-Columbia |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 161 |
| Start date | 1 May 2008 |
| Primary completion | 1 May 2010 |
| Estimated completion | 1 May 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Nitrofurantoin (NITROFURANTOIN) — full drug profile →
- Placebo
Conditions studied
- Stress Incontinence — all drugs for Stress Incontinence →
Sponsor
University of Missouri-Columbia
Who can join
18 and older, female only, with Stress Incontinence. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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%.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00734968
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nitrofurantoin
Trials testing the same drug.
- NCT07202832 — Urine Alkalinization for UTI in Women: RCT · NA · not yet recruiting
- NCT07186465 — Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis · Phase 4 · recruiting
- NCT06332781 — Intravesical Gentamicin to Prevent Recurrent UTI · Phase 4 · completed
- NCT05274672 — Role of Prophylactic Postoperative Antibiotics in HoLEP · Phase 4 · withdrawn
- NCT05630833 — A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urina · Phase 3 · completed
Other recruiting trials for Stress Incontinence
Currently open trials in the same condition.
- NCT06352879 — Prevalence, Types and Risk Factors of Urinary Incontinence Among Women in Baghdad, Iraq. · recruiting
Other University of Missouri-Columbia trials
Trials by the same sponsor.
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- NCT07067502 — Impact of Biphasic Cuirass Ventilation Compared to Non Invasive Ventilation in High Risk Extubations · NA · not yet recruiting
- NCT07424079 — Metacognitive Strategy Training Intervention for Transition-Age Youth With Cerebral Palsy · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00734968 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Missouri-Columbia
- Last refreshed: 17 August 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00734968.
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