Why don't women participate? A qualitative study on non-participation in a surgical randomised controlled trial.

INTRODUCTION AND HYPOTHESIS: The objective of the study was to identify reasons why women declined participation in a pilot randomised controlled trial (RCT) comparing tension-free vaginal tape (TVT) under general anaesthetic (GA) with single incision sling (SIS) under local anaesthetic (LA). These data would inform the design of a larger trial to improve patient recruitment. METHODS: This was a qualitative interview study on women eligible to have a TVT for stress urinary incontinence in a tertiary referral hospital in the UK. Women were counselled in a standardised manner. They were informed that the short-term success rates were similar for both operations. Women who declined to take part in the RCT were interviewed using a topic guide. Themes and sub-themes on non-participation were identified by two independent observers using a constant comparison method. RESULTS: Twenty-three non-participants of the RCT were interviewed. Common themes for non-participation were a preference for TVT and request for GA. Sub-themes showed that the TVT was preferred due to its perceived better efficacy as well as a minimal benefit from a SIS and also an unwillingness to take unknown risks. GA was favoured due to fear of local awareness, past negative experiences and embarrassment. Additional tests and follow-up visits were not cited as a reason for non-participation. CONCLUSIONS: The study found that non-participants are not research averse in general but they had strong preferences about specific aspects of treatment. Risk propensity and personality may also influence this behaviour. The study also demonstrates how a qualitative pilot study may improve trial design.

Periurethral abscess following polyacrylamide hydrogel (Bulkamid) for stress urinary incontinence.

Bulkamid is a periurethral bulking agent used to treat stress urinary incontinence (SUI). Manufacturers describe it as nontoxic, nonbiodegradable and biocompatible. Periurethral abscesses are one of the known complications of bulking agents. We present the first reported case of periurethral abscess following Bulkamid injection. The woman had previously had a transobturator tape (TOT) and total vaginal mesh repair. At 6 weeks after injection of the bulking agent, she reported 100 % cure of her SUI. Transperineal ultrasound was used to diagnose and monitor an abscess that developed anterior and lateral to the urethra and separate from the TOT. Magnetic resonance imaging was helpful in delineating the extent of the abscess into the retropubic space but was not able to identify the urethra or the TOT. Surgical drainage of the abscess was performed vaginally, resulting in successful resolution of pain but recurrence of incontinence.

A 2-year observational study to determine the efficacy of a novel single incision sling procedure (Minitape) for female stress urinary incontinence.

OBJECTIVE: Assessment of the 2 year outcome of the Minitape procedure. DESIGN: A prospective observational study of women undergoing the Minitape procedure for urodynamic stress incontinence. Setting Two tertiary referral urogynaecology units in the north of England. POPULATION: Sixty women between November 2002 and March 2006. METHODS: Women attended a research clinic where they completed a standardised 1 hour pad test and were examined. Women were assessed preoperatively and postoperatively at 6 months, 1 year and 2 years. MAIN OUTCOME MEASURES: Success was determined by a negative 1 hour pad test (gain of <1 g) and no desire for further treatment for stress urinary incontinence. RESULTS: All procedures were completed with local anaesthesia, with no additional sedation in 82% of cases. Intra-operative and immediate postoperative complications were rare. Twelve women (20%) experienced mesh complications, half of which were considered to be serious adverse events requiring exit from the study. At 2 years following Minitape insertion, six women (10%) were defined as cured. CONCLUSIONS: Although feasible to perform, this procedure is associated with a substantially lower cure rate than that published previously for other procedures. Cure rates decline over the 2 year follow-up period, especially during the first 6 months.

A prospective study of laparoscopic sacrocolpopexy for the management of pelvic organ prolapse.

OBJECTIVE: Assessment of the 2-year outcome of laparoscopic sacrocolpopexy. DESIGN: A prospective observational study of women undergoing laparoscopic sacrocolpopexy for prolapse. SETTING: A tertiary referral unit in the North West of England. POPULATION: A total of 22 women taking part in a prospective longitudinal study of prolapse who had a laparoscopic sacrocolpopexy between September 2002 and January 2005. METHODS: Women attended a research clinic where they completed validated quality-of-life questionnaires and were examined. Women were assessed preoperatively and postoperatively at 6 months, 1 year and 2 years. MAIN OUTCOME MEASURES: Pelvic organ support assessed by Pelvic Organ Prolapse Quantification score. Assessment of the degree and impact of vaginal, urinary and bowel symptoms using validated quality-of-life questionnaires. RESULTS: At a mean follow up of 26.5 months, all 22 women had stage 0 vault support with 21 cured of prolapse symptoms. Stress urinary incontinence resolved in half of women without concomitant continence surgery. Bowel symptoms were uncommon, but of those reporting postoperative bowel symptoms, approximately one-third had no symptoms prior to surgery. No new onset dyspareunia was reported in those women sexually active at 2 years. CONCLUSIONS: Laparoscopic sacrocolpopexy is a safe and effective treatment for vault prolapse, providing excellent vault support in the medium term. The outcome for anterior and posterior support is less predictable, and anatomical outcome correlated poorly with functional outcome.

The effect of physical activity on pelvic organ prolapse.

OBJECTIVE: The objective of this study was to determine whether pelvic organ prolapse increases after physical activity. DESIGN: Prospective observational study. SETTING: St Mary's Hospital, Manchester, UK. SAMPLE: Women undergoing surgery for pelvic organ prolapse. METHODS: Fifty-four women were recruited to the study. Symptoms and POPQ findings were assessed after a period of prescribed activity and overnight bedrest. MAIN OUTCOME MEASURES: Primary outcome was an increase in Pelvic Organ Prolapse Quantification (POPQ) measurements with activity. Secondary outcomes were association of symptoms or quality-of-life scores (Pelvic Floor Distress Inventory [PFDI] and Pelvic Floor Impact Questionnaire [PFIQ]) with an increase in POPQ measurements. RESULTS: There was a significant increase in POPQ stage and five vaginal parameters (Aa, Ba, C, Ap and Bp) with physical activity (P < 0.001). Reported symptoms, higher PFDI and PFIQ scores and higher individual symptom bother scores were not more common in the women with greater pelvic organ descent (measured by the POPQ system) following physical activity. CONCLUSIONS: Greater pelvic organ prolapse was found on POPQ examination following physical activity, but this was not associated with worsening of symptoms and greater impairment of quality of life.

A valsalvometer can be effective in standardising the Valsalva manoeuvre.

A prospective randomised controlled study was performed in order to study the effectiveness of a device designed to reduce the variability in intra-abdominal pressures generated by individuals performing the Valsalva manoeuvre. One hundred women were recruited to take part in the project which compared a traditional Valsalva manoeuvre following standardised verbal instruction with forced expiration through a flow restriction device called a "valsalvometer". The abdominal pressure was measured using an air-filled rectal balloon catheter linked to a pressure transducer. The use of the valsalvometer was associated with a reduction in variation of intra-abdominal pressure between women to 50% of the standard deviation. The new device has the capacity to reduce the variation in intra-abdominal pressure produced when performing the Valsalva manoeuvre. The rise in intra-abdominal pressure may act as a standard against which other measurements are made.

Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial.

OBJECTIVE: To compare the effectiveness and cost effectiveness of open and laparoscopic colposuspension in the treatment of stress urinary incontinence. DESIGN: A randomised controlled trial. Women were randomised between March 1999 and February 2002 and were seen for assessment at 6, 12 and 24 months, postoperatively. SETTING: Women were recruited from six gynaecology units in the UK. POPULATION: Women with proven stress urinary incontinence requiring surgery. METHODS: Open abdominal retropubic colposuspension or laparoscopic colposuspension. MAIN OUTCOME MEASURES: Primary outcomes were subjective (satisfaction with outcome) and objective (negative 1-hour pad test). Secondary outcomes were operative and postoperative morbidity and quality of life. The study was powered to demonstrate noninferiority, i.e. that the absolute cure rate of laparoscopic colposuspension was no more than 15% below that of open colposuspension. RESULTS: A total of 291 women were randomised, with 24-month data on subjective and objective outcomes in 88 and 82.5%, respectively. The intention-to-treat analysis indicated no significant difference in cure rates between open and laparoscopic surgery. The objective cure rates for open and laparoscopic were 70.1 and 79.7%, respectively. Subjective cure rates by satisfaction were lower than objective cure; 54.6 and 54.9%, respectively, and there was considerable nonconcordance both ways. CONCLUSIONS: Laparoscopic colposuspension is not inferior to open colposuspension in terms of curing stress urinary incontinence.

Cost-effectiveness analysis of open colposuspension versus laparoscopic colposuspension in the treatment of urodynamic stress incontinence.

OBJECTIVES: To compare the cost effectiveness of laparoscopic versus open colposuspension for the treatment of female urinary stress incontinence. DESIGN: Cost utility analysis alongside a randomised controlled trial. SETTING: Six gynaecological surgical centres within the UK. POPULATION/SAMPLE: Women with proven stress urinary incontinence requiring surgery. METHODS: Open abdominal retropubic colposuspension or laparoscopic colposuspension carried out by experienced surgeons. MAIN OUTCOME MEASURES: Cost, measured in pounds sterling and generic health-related quality of life, measured using the EQ-5D. The latter was used to estimate patient-specific quality-adjusted life years (QALYs). RESULTS: Healthcare resource use over 6-month follow up translated into costs of pound 1805 for the laparoscopic arm and pound 1433 for the open arm (differential mean cost pound 372; 95% credibility interval [CrI]: 274-471). At 6 months, QALYs were slightly higher in the laparoscopic arm relative to the open arm (0.005; 95% CrI: -0.012 to 0.023). Therefore, the cost of each extra QALY in the laparoscopic group (the incremental cost-effectiveness ratio [ICER]) was pound 74,400 at 6 months. At 24 months, the laparoscopic arm again had a higher mean QALY score compared to the open surgery group. Thus, assuming that beyond 6 months the laparoscopic colposuspension would not lead to any significant additional costs compared with open colposuspension, the ICER was reduced to pound 9300 at 24 months. Extensive sensitivity analyses were carried out to test assumptions made in the base case scenario. CONCLUSIONS: Laparoscopic colposuspension is not cost effective when compared with open colposuspension during the first 6 months following surgery, but it may be cost effective over 24 months.

Long term review of laparoscopic sacrocolpopexy.

OBJECTIVE: Assessment of long term outcome following laparoscopic sacrocolpopexy. DESIGN: Retrospective follow up study using standardised examination with pelvic organ prolapse quantification system (POP-Q) and questionnaires. SETTING: A tertiary urogynaecology unit in the North West of England. POPULATION: One hundred and forty consecutive cases who had a laparoscopic sacrocolpopexy at St Mary's Hospital, Manchester, between 1993 and 1999. METHODS: Women completed questionnaires and were examined in gynaecology clinic or sent postal questionnaires if unable to attend the clinic. MAIN OUTCOME MEASURES: Adequacy of vault support and recurrent vaginal prolapse assessed by POP-Q score. Assessment of prolapse, urinary and bowel symptoms and sexual function using questionnaires. RESULTS: One hundred and three women were contacted after a median of 66 months. Sixty-six women were examined and a further 37 women filled in questionnaires only. Recurrent vault prolapse occurred in 4 of the 66 women who were examined. Prolapse had recurred or persisted in 21 of 66 women, with equal numbers of anterior and posterior vaginal wall prolapse. Overall, 81/102 (79%) said that their symptoms of prolapse were 'cured' or 'improved'; 39/103 (38%) still had symptoms of prolapse. For every two women who were cured of their urinary or bowel symptoms, one woman developed worse symptoms. CONCLUSIONS: Among the 66 women available for examination laparoscopic sacrocolpopexy provided good long term support of the vault in 92%. Forty-two percent of these women had recurrent vaginal wall prolapse. Despite this, 79% of women felt that their symptoms of prolapse were cured or improved following surgery.

Evidence-based practice in urogynaecology.

Urogynaecology practice is rapidly progressing, with a trend towards minimally invasive techniques. This article attempts to cover the evidence behind the assessment and treatment of urinary and anal incontinence, and vaginal prolapse.

Strength-duration testing of the external anal sphincter in females with anorectal dysfunction.

PURPOSE: The strength-duration test has been suggested as a means of assessing external anal sphincter function. This study was designed to investigate this claim by comparing the strength-duration test with established measures of external anal sphincter function. METHODS: Forty-nine females undergoing diagnostic anorectal testing (manometry, rectal sensation, electromyogram, pudendal nerve terminal motor latency, and endoanal ultrasound) also had the strength-duration test performed (which was repeated for each patient after a short rest period). RESULTS: The strength-duration test was repeatable. Statistically significant correlations were found between this test at pulse durations of 3 ms, 1 ms, and 0.3 ms with electromyographic activity of the external anal sphincter and with pressure in the anal canal during voluntary contraction. Significant correlations were found for durations of 100 ms, 30 ms, 10 ms, and 3 ms with the pudendal nerve terminal motor latency on the right and for the 3 ms and 0.3 ms durations with latency on the left. There were no correlations between the strength-duration test and resting pressure in the anal canal. CONCLUSION: The strength-duration test significantly correlates with the established measures of external anal sphincter function and its innervation. Therefore, this simple test appears to provide a simple measure of external anal sphincter denervation.