Diane Stark

A randomized controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse

Forty-seven women participated in a pilot study for a multi-centre randomized controlled trial of the effectiveness of pelvic floor muscle training (PFMT) for women with prolapse. Women with symptomatic stage I or II prolapse [measured by Pelvic Organ Prolapse Quantification (POP-Q)] were randomized to a 16-week physiotherapy intervention (PFMT and lifestyle advice; n = 23) or a control group receiving a lifestyle advice sheet (n = 24). Symptom severity and quality of life were measured via postal questionnaires. Blinded POP-Q was performed at baseline and follow-up. Intervention women had significantly greater improvement than controls in prolapse symptoms (mean score decrease 3.5 versus 0.1, p = 0.021), were significantly more likely to have an improved prolapse stage (45% versus 0%, p = 0.038) and were significantly more likely to say their prolapse was better (63% versus 24%, p = 0.012). The data support the feasibility of a substantive trial of PFMT for prolapse. A multi-centre trial is underway.

A randomized controlled trial of urodynamic investigations prior to conservative treatment of urinary incontinence in the female

Sixty patients complaining of frequency, urgency, nocturia, urge incontinence and stress incontinence were randomly allocated to either undergo conservative treatment by way of combined physiotherapy and bladder retraining as an inpatient without prior urodynamics, or to have urodynamic investigations and treatment tailored to the urodynamic diagnosis. The assessment period was 3 months and assessment was made pre- and posttreatment by urinary diary, pad testing and subjective questionnaire. There was a significant improvement posttreatment for each parameter studied, with the exception of pad testing. There was no significant difference between the two groups for any parameter. Two-thirds of patients were cured to the extent that they did not require further treatment, and again there was no difference between the two groups. We conclude that patients attending for the first time with an uncomplicated story of urinary incontinence can be effectively treated conservatively without prior urodynamics.

Psychometric properties of the pelvic organ prolapse symptom score

Objective  To assess the internal consistency, construct validity and sensitivity to change of a pelvic organ prolapse symptom score (POP‐SS).

A prospective, randomized controlled trial of inpatient versus outpatient continence programs in the treatment of urinary incontinence in the female

Seventy-four patients presenting with a mixed pattern of urinary symptoms were randomly allocated to undergo either inpatient or outpatient continence programs as initial treatment, without prior urodynamic investigation. Both programs consisted of physiotherapy, bladder retraining, fluid normalization, dietary advice and general support and advice. Nine out of 39 in the outpatient group and 8 out of the 35 of the impatient group failed to complete the study. There was a significant decrease in frequency, nocturia, number of incontinent episodes and visual analog scores for both groups. In addition the outpatients had a significant reduction in loss on pad testing, and a significantly greater improvement in their visual analog score. In each group 63% were cured or improved to the extent that they did not require further treatment. Staff costs per outpatient were half those for an inpatient. We conclude that outpatient conservative treatment as detailed above is a successful first-line treatment of urinary incontinence in women. It is as successful and possibly better than inpatient treatment, and is significantly cheaper.

2014 consensus statement on improving pelvic floor muscle training adherence: International Continence Society 2011 State-of-the-Science Seminar.

To summarize the findings and “expert‐panel” consensus of the State‐of‐the‐Science Seminar on pelvic floor muscle training (PFMT) adherence held prior to the 41st International Continence Society scientific meeting, Glasgow, 2011.

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings

BackgroundSuccessful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them.MethodsGynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment.ResultsSome strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient’s preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment.ConclusionsOur article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and providing collaborator incentives. Barriers to recruitment included fewer eligible women than anticipated, patient’s preference to be allocated to the treatment group, lack of support staff, and variations in approval systems and GP referral procedures. To improve the evidence base on clinical trial recruitment, trialists need to publish their experiences and lessons learned. Future RCTs should evaluate, where possible, the effect of strategies designed to improve recruitment and retention.Trial registrationCurrent Controlled Trials ISRCTN35911035

Pelvic‐Floor‐Muscle Training Adherence: Tools, Measurements and Strategies—2011 ICS State‐of‐the‐Science Seminar Research Paper II of IV

This paper on pelvic‐floor‐muscle training (PFMT) adherence, the second of four from the International Continence Societys 2011 State‐of‐the‐Science Conference, aims to (1) identify and collate current adherence outcome measures, (2) report the determinants of adherence, (3) report on PFMT adherence strategies, and (4) make actionable clinical and research recommendations.