Christopher Mayne

Long-Term Safety, Tolerability and Efficacy of Extended-Release Tolterodine in the Treatment of Overactive Bladder

BACKGROUNDnThe objective of the present study was to examine the long-term safety, tolerability and efficacy of tolterodine extended-release (ER) in patients who had completed 12 weeks treatment in a randomised, double-blind study comparing tolterodine ER 4 mg once daily (qd), tolterodine immediate-release (IR) 2mg twice daily and placebo.nnnMETHODSnOf the 1377 patients completing the 12-week study, a total of 1077 (78%) chose to continue with 12 months open-label treatment with tolterodine ER 4 mg once daily, irrespective of their previous treatment. Safety was assessed after 3, 6, 9 and 12 months treatment in the study. Efficacy was evaluated from micturition diary variables and patients perception of bladder condition and urgency following 3 and 12 months treatment.nnnRESULTSn71% of patients completed the 12-month study. Tolterodine ER was safe and well tolerated. Adverse events of the general (14.5%), autonomic (13.2%), gastrointestinal (11.4%), respiratory (9.8%) and urinary (9.1%) systems were the most frequently reported. Dry mouth was the most common event, occurring in 12.9% of patients, and was generally mild in severity. Other adverse events occurred in less than 5% of patients. There was no increase in the frequency of adverse events with long-term relative to short-term treatment. The efficacy of tolterodine was maintained over the 12-month treatment period; relative to baseline there were reductions in the number of incontinence episodes per week (median change -83%) and micturitions per 24 hours (median change -21%) and an increase in volume voided (median change +25%) after 12 months treatment. An improvement in patient perception of their bladder condition was found in 75% of patients completing the study, and 51% had an improvement in patient perception of urgency.nnnCONCLUSIONSnTolterodine ER 4mg qd displayed a favourable safety, tolerability and efficacy profile during 12 months treatment of patients with overactive bladder.

Clinically overt postpartum urinary retention after vaginal delivery: a retrospective case-control study

We set out to determine the incidence of symptomatic postpartum urinary retention (PUR) after vaginal delivery and to establish any associated risk factors. We carried out a retrospective case-control study of women having PUR after vaginal delivery from 2001 to 2005. Four controls, matched for date of delivery, were selected for each case in univariate and multivariate conditional logistic regression analyses. There were 15,757 deliveries and 30 cases of PUR (incidence 0.2%). Median duration of PUR was 19xa0days (range 3–85). Eighty percent were managed with intermittent self-catheterization. The use of regional analgesia increased the risk of PUR [odds ratio (OR) 6.33, 95% confidence interval (CI) 2.01–19.96], while ethnicity (Caucasian vs Asian) reduced the risk (OR 0.27, CI 0.08–0.85) (p<0.05). PUR is uncommon but carries significant morbidity. Epidural analgesia and Asian ethnic origin increase the risk. We recommend routine catheterization for up to 24xa0h after delivery after epidural analgesia.

Randomized Trial of Tension-Free Vaginal Tape and Tension-Free Vaginal Tape-Obturator for Urodynamic Stress Incontinence in Women

PURPOSEnWe compared the efficacy and complications of tension-free vaginal tape and tension-free vaginal tape-obturator.nnnMATERIALS AND METHODSnWomen with pure urodynamic stress incontinence undergoing only primary continence surgery were randomized to tension-free vaginal tape or tension-free vaginal tape-obturator at 2 centers between March 2005 and March 2007. Primary outcome was objective cure rate at 6 months, defined by a 24-hour pad test of less than 5 gm. Secondary outcomes were the subjective cure rate on the Patient Global Impression of Improvement, quality of life on the Kings Healthcare Questionnaire and symptom severity scores on the International Consultation on Incontinence Questionnaire.nnnRESULTSnA total of 127 women were recruited. The study was stopped early due to excess leg pain in the tension-free vaginal tape-obturator group. Of the women 66 were randomized to tension-free vaginal tape and 61 were randomized to tension-free vaginal tape-obturator. Analysis was done by intent to treat. The objective and subjective cure rate at 6 months for tension-free vaginal tape vs tension-free vaginal tape-obturator was 69.7% vs 72.1% and 72.7% vs 67.2% (p = 0.76 and 0.49, respectively). Cure rates at 1 year were similar but loss to followup was high. Objective and subjective cure rates at 1 year for tension-free vaginal tape vs tension-free vaginal tape-obturator were 50% vs 41% and 53% vs 42.6% (p = 0.31 and 0.24, respectively). More women complained of leg pain after receiving a tension-free vaginal tape-obturator (26.4% vs 1.7%, p = 0.0001). The incidence of perioperative complications was low and similar between the groups. Time to discharge home and time to normal activity were not significantly different.nnnCONCLUSIONSnShort-term cure rates at 6 months were similar. Tension-free vaginal tape-obturator caused more transient leg pain. Each procedure achieved a high cure rate and a low complication rate.

Ectopic pregnancy with a translocated Mirena intrauterine system.

A woman, fitted with a Mirena® intrauterine system (IUS), presented with a positive pregnancy test and a 5-day history of per vaginam bleeding and left iliac fossa pain. Beta-hCG level was raised at 1815 IU/l and a pelvic ultrasound scan showed a normal empty uterus. An abdominal x-ray showed that the IUS was in the left hypochondrium. At laparoscopy, an ectopic pregnancy was discovered in the left fallopian tube. The IUS was removed laparoscopically. This is likely to be the first reported case of a simultaneous ectopic pregnancy and an extrauterine system. It is not clear whether removal of the Mirena® IUS was necessary.

Postoperative urinary tract infections (UTIs) following single-dose intraoperative antibiotic prophylaxis in colposuspension patients

The records of 196 women who underwent colposuspension for genuine stress incontinence at the Leicester General Hospital, England, between June 1991 and May 1996 were reviewed for evidence of urinary tract infection (UTI). Variables analyzed include age, type of anbibiotic, timing of a positive culture, organism(s) responsible and antibiotic sensitivity. Forty-six patients (23.47%) developed urinary infection; of these, 42 had received single-dose antibiotic prophylaxis with suprapubic catheterization. Thirty-two (76%) of those who developed UTI received augmentin (amoxycillin and clavulanic acid), whereas 10 (24%) were given cefuroxime and metronidazole. Positive cultures were obtained between postoperative days 3 and 28, with a mean of 9.6 days, and 81% occurred after the 7th day. Coliform organisms were responsible for nearly 70% of the infections. UTI is still common after colposuspension, despite single-dose antibiotic prophylaxis. Further studies looking at longer or alternative courses of antibiotics or clean intermittent self-catheterization are essential to establish the best way of curbing UTI in urogynecology patients.

Recurrent urinary tract infection in gynaecological practice

• Urinary tract infection (UTI) is the result of interaction between host defences and bacterial pathogenic mechanisms. • Recurrent UTI can be associated with urinary tract abnormalities. • Urinary tract imaging is useful in a minority of women to identify pathological, structural or functional abnormalities. • Adequate fluid intake, topical estrogens and prophylactic antibiotics can be useful in the management of recurrent infections. • Symptoms often reappear despite adequate treatment.