Mary Kilonzo

Background: Those experiencing homelessness and problem substance use find it challenging to access the healthcare and treatment they need. The Supporting Harm Reduction through Peer Support (SHARPS) feasibility study demonstrated that Peer Navigators can help these individuals to improve their service engagement, increase access to opioid substitution therapy, and lead to reductions in drug use and risky injection practices. Specifically, participants indicated that the lived experience of Peer Navigators was particularly helpful by enabling the development of trusting relationships. A cluster randomised controlled trial (cRCT) will now assess the effectiveness and cost-effectiveness of a Peer Navigator intervention with this population. Methods: A two-arm, pragmatic, cRCT will be conducted with embedded cost-effectiveness and mixed methods process evaluations. Individuals will be recruited who are as follows: over the age of 18 years; experiencing/at risk of homelessness and self-report problem substance use; and attending The Salvation Army (TSA) homelessness services across 20 included clusters (towns/cities). Each cluster will be randomised (1:1) to either the intervention or control arm using covariate-constrained allocation based on area-level characteristics. The target sample size is 550 participants in total. A co-produced peer-delivered harm reduction, relational intervention lasting 12 months will be delivered to those in the intervention arm. Usual care will be social care via TSA Support Workers delivered within homelessness services. The co-primary outcomes will be mental health and quality of life, with harmful substance use, risk taking behaviours, social functioning, physical health, social outcomes, housing status, therapeutic alliance/accessibility, service utilisation, and relational empathy chosen as secondary outcomes. Data collection points are baseline, 6 and 12 months, for all measures. The primary timepoint of interest is 12 months after baseline measurement. Economic outcomes will be incremental cost per quality-adjusted life year (QALY) and per year in full capability (YFC) gained with the intervention versus standard homelessness service care, inclusive of costs to the NHS, local government and criminal justice, and the third-sector host organisation. The EQ-5D-5L and ICECAP-A will be used to calculate QALYs and YFC respectively. We will also conduct a cost-consequence analysis. Discussion: The results of this trial will be used to inform whether the SHARPS intervention has a positive impact on those experiencing homelessness and problem substance use and if it is cost-effective to roll it out across social care services. Trial registration: ISRCTN11094645 ( https://doi.org/10.1186/ISRCTN11094645 , registered April 5, 2024).

Objectives To explore trial participants’ experience of long-term catheters (LTC), the acceptability of washout policies, their experience of the CATHETER II trial (a randomised controlled trial comparing the clinical effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters) and their satisfaction with the outcomes. The objectives of the healthcare professionals (HCPs) focus group and interview were to explore their attitudes towards weekly prophylactic catheter washout, views on the provision of training and participants’ ability to enact washout behaviours. Methodology A longitudinal qualitative study embedded within the CATHETER II randomised controlled trial, which included semi-structured interviews and focus groups with participants from multiple trial sites. Data were analysed using the Theoretical Framework of Acceptability and Theoretical Domains Framework. This UK community-based study included 50 (24 female, 26 male) CATHETER II trial participants, aged between 23 and 100 years, with LTC and able to self-manage the washout and study documentation either independently or with the help of a carer. Seven HCPs (five female, two male) also participated. Results The participants had positive attitudes towards weekly prophylactic saline or acidic catheter washouts and other trial elements, such as washout training, catheter calendar and monthly phone calls. Participants and HCPs found the ‘ask’ of the CATHETER II trial and the weekly self-administered prophylactic washout policies to be feasible. The participants reported that the catheter washout training provided during the trial enhanced their self-efficacy, skills and self-reported capability to carry out the washouts. Participants reported having positive outcomes from the weekly washout. These included reduced blockage, pain or infection, reduced need for HCP support and greater psychological reassurance. HCPs attested to the participants’ understanding of and adherence to the weekly washouts and other elements of the trial. Conclusions This study shows acceptability, feasibility and self-reported fidelity of the CATHETER II trial on a behavioural level. Self-management for prophylactic catheter washouts is both feasible and, following training, achievable without any need for additional support. Trial registration number ISRCTN17116445.

Objectives Do weekly prophylactic saline or acidic catheter washouts in addition to standard long-term catheter (LTC) care improve the outcomes of adults with LTC compared with standard LTC care only. Design Three-arm superiority open-label randomised controlled trial. Setting UK community-based study. Participants 80 adults with LTC (any type/route) ≥28 days in situ with no plans to discontinue and able to self-manage the washouts/study documentation with/without a carer. Interventions Randomly allocated (26:27:27) to receive standard LTC care with weekly saline or weekly acidic or no prophylactic washouts for up to 24 months. Primary and secondary outcome measures The primary outcome was catheter blockage requiring intervention (per 1000 catheter days). Secondary outcomes were symptomatic catheter-associated urinary tract infection (S-CAUTI) requiring antibiotics, adverse events, participants’ quality of life and day-to-day activities, acceptability and adherence. Results Outcomes reported for 25 saline, 27 acidic and 26 control participants. LTC blockages (per 1000 catheter days) requiring treatment were 9.96, 10.53 and 20.92 in the saline, acidic and control groups, respectively. The incident rate ratio (IRR) favours the washout groups (saline 0.65 (97.5% CI 0.24 to 1.77); p=0.33 and acidic 0.59 (97.5% CI 0.22 to 1.63); p=0.25), although not statistically significant. The S-CAUTI rate (per 1000 catheter days) was 3.71, 6.72 and 8.05 in the saline, acidic and control groups, respectively. The IRR favours the saline group (saline 0.40 (97.5% CI 0.20 to 0.80); p=0.003 and acidic 0.98 (97.5% CI 0.54 to 1.78); p=0.93). The trial closed before reaching target recruitment due to reduced research capacity during the COVID-19 pandemic. Conclusions Early closure and small sample size limits our ability to provide a definite answer. However, the observed non-statistically significant differences over control are favourable for lower rates of LTC blockages without a concomitant rise in S-CAUTI. The results support a multinational randomised controlled trial of catheter washouts in patients with LTC to ascertain their clinical and cost-effectiveness. Trial registration number ISRCTN17116445.

Objective: To report on the cost‐effectiveness of adjustable anchored single‐incision mini‐slings (mini‐slings) compared with tension‐free standard mid‐urethral slings (standard slings) in the surgical management of female stress urinary incontinence (SUI).Patients and Methods: Data on resource use and quality were collected from women aged ≥18 years with predominant SUI undergoing mid‐urethral sling procedures in 21 UK hospitals. Resource use and quality of life (QoL) data were prospectively collected alongside the Single‐Incision Mini‐Slings versus standard synthetic mid‐urethral slings Randomised Control Trial (SIMS RCT), for surgical treatment of SUI in women. A health service provider's (National Health Service [NHS]) perspective with 3‐year follow‐up was adopted to estimate the costs of the intervention and all subsequent resource use. A generic instrument, EuroQol EQ‐5D‐3L, was used to estimate the QoL. Results are reported as incremental costs, quality adjusted life years (QALYs) and incremental cost per QALY.Results: Base case analysis results show that although mini‐slings cost less, there was no significant difference in costs: mini‐slings versus standard slings: £‐6 [95% CI −228–208] or in QALYs: 0.005 [95% CI −0.068–0.073] over the 3‐year follow‐up. There is substantial uncertainty, with a 56% and 44% probability that mini‐slings and standard slings are the most cost‐effective treatment, respectively, at a £20 000 willingness‐to‐pay threshold value for a QALY.Conclusions: At 3 years, there is no significant difference between mini‐slings and standard slings in costs and QALYs. There is still some uncertainty over the long‐term complications and failure rates of the devices used in the treatment of SUI; therefore, it is important to establish the long‐term clinical and cost‐effectiveness of these procedures.

Background: Stress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable anchored single-incision mini-slings are newer, use less mesh and may reduce perioperative morbidity, but it is unclear how their success rates and safety compare with those of standard tension-free mid-urethral slings.Objective: The objective was to compare tension-free standard mid-urethral slings with adjustable anchored single-incision mini-slings among women with stress urinary incontinence requiring surgical intervention, in terms of patient-reported effectiveness, health-related quality of life, safety and cost-effectiveness.Design: This was a pragmatic non-inferiority randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio).Setting: The trial was set in 21 UK hospitals.Participants: Participants were women aged ≥ 18 years with predominant stress urinary incontinence, undergoing a mid-urethral sling procedure.Interventions: Single-incision mini-slings, compared with standard mid-urethral slings.Main outcome measures: The primary outcome was patient-reported success rates on the Patient Global Impression of Improvement scale at 15 months post randomisation (≈ 1 year post surgery), with success defined as outcomes of ‘very much improved’ or ‘much improved’. The primary economic outcome was incremental cost per quality-adjusted life-year gained. Secondary outcomes were adverse events, impact on other urinary symptoms, quality of life and sexual function.Results: A total of 600 participants were randomised. At 15 months post randomisation, adjustable anchored single-incision mini-slings were non-inferior to tension-free standard mid-urethral slings at the 10% margin for the primary outcome [single-incision mini-sling 79% (212/268) vs. standard mid-urethral sling 76% (189/250), risk difference 4.6, 95% confidence interval –2.7 to 11.8;p_{non-inferiority} < 0.001]. Similarly, at 3 years’ follow-up, patient-reported success rates in the single-incision mini-sling group were non-inferior to those of the standard mid-urethral sling group at the 10% margin [single-incision mini-sling 72% (177/246) vs. standard mid-urethral sling 67% (157/235), risk difference 5.7, 95% confidence interval –1.3 to 12.8;p_{non-inferiority} < 0.001]. Tape/mesh exposure rates were higher for single-incision mini-sling participants, with 3.3% (9/276) [compared with 1.9% (5/261) in the standard mid-urethral sling group] reporting tape exposure over the 3 years of follow-up. The rate of groin/thigh pain was slightly higher in the single-incision mini-sling group at 15 months [single-incision mini-sling 15% (41/276) vs. standard mid-urethral sling 12% (31/261), risk difference 3.0%, 95% confidence interval –1.1% to 7.1%]; however, by 3 years, the rate of pain was slightly higher among the standard mid-urethral sling participants [single-incision mini-sling 14% (39/276) vs. standard mid-urethral sling 15% (39/261), risk difference –0.8, 95% confidence interval –4.1 to 2.5]. At the 3-year follow-up, quality of life and sexual function outcomes were similar in both groups: for the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life, the mean difference in scores was –1.1 (95% confidence interval –3.1 to 0.8;p = 0.24), and for the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised, it was 0 (95% confidence interval –0.1, 0.1;p = 0.92). However, more women in the single-incision mini-sling group reported dyspareunia [12% (17/145), compared with 4.8% (7/145) in the standard mid-urethral sling group, risk difference 7.0%, 95% confidence interval 1.9% to 12.1%]. The base-case economics results showed no difference in costs (–£6, 95% confidence interval –£228 to £208) or quality-adjusted life-years (0.005, 95% confidence interval -0.068 to 0.073) between the groups. There is a 56% probability that single-incision mini-slings will be considered cost-effective at the £20,000 willingness-to-pay threshold value for a quality-adjusted life-year.Limitations: Follow-up data beyond 3 years post randomisation are not available to inform longer-term safety and cost-effectiveness.Conclusions: Single-incision mini-slings were non-inferior to standard mid-urethral slings in patient-reported success rates at up to 3 years’ follow-up.Future work: Success rates, adverse events, retreatment rates, symptoms, and quality-of-life scores at 10 years’ follow-up will help inform long-term effectiveness.Trial registration: This trial was registered as ISRCTN93264234.Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 26, No. 47. See the NIHR Journals Library website for further project information.

Objectives: To assess the cost‐effectiveness, resource use implications, quality‐adjusted life‐years (QALYs) and cost per QALY of care pathways starting with either extracorporeal shockwave lithotripsy (SWL) or with ureteroscopic retrieval (ureteroscopy [URS]) for the management of ureteric stones. Patients and Methods: Data on quality of life and resource use for 613 patients, collected prospectively in the Therapeutic Interventions for Stones of the Ureter (TISU) randomized controlled trial (ISRCTN 92289221), were used to assess the cost‐effectiveness of two care pathways, SWL and URS. A health provider (UK National Health Service) perspective was adopted to estimate the costs of the interventions and subsequent resource use. Quality‐of‐life data were calculated using a generic instrument, the EuroQol EQ‐5D‐3L. Results are expressed as incremental cost‐effectiveness ratios and cost‐effectiveness acceptability curves. Results: The mean QALY difference (SWL vs URS) was −0.021 (95% confidence interval [CI] −0.033 to −0.010) and the mean cost difference was −£809 (95% CI −£1061 to −£551). The QALY difference translated into approximately 10 more healthy days over the 6‐month period for the patients on the URS care pathway. The probabaility that SWL is cost‐effective is 79% at a society's willingness to pay (WTP) threshold for 1 QALY of £30,000 and 98% at a WTP threshold of £20,000. Conclusion: The SWL pathway results in lower QALYs than URS but costs less. The incremental cost per QALY is £39 118 cost saving per QALY lost, with a 79% probability that SWL would be considered cost‐effective at a WTP threshold for 1 QALY of £30 000 and 98% at a WTP threshold of £20 000. Decision‐makers need to determine if costs saved justify the loss in QALYs.

Background: Stress urinary incontinence is common in men after prostate surgery and can be difficult to improve. Implantation of an artificial urinary sphincter is the most common surgical procedure for persistent stress urinary incontinence, but it requires specialist surgical skills, and revisions may be necessary. In addition, the sphincter is relatively expensive and its operation requires adequate patient dexterity. New surgical approaches include the male synthetic sling, which is emerging as a possible alternative. However, robust comparable data, derived from randomised controlled trials, on the relative safety and efficacy of the male synthetic sling and the artificial urinary sphincter are lacking.Objective: We aimed to compare the clinical effectiveness and cost-effectiveness of the male synthetic sling with those of the artificial urinary sphincter surgery in men with persistent stress urinary incontinence after prostate surgery.Design: This was a multicentre, non-inferiority randomised controlled trial, with a parallel non-randomised cohort and embedded qualitative component. Randomised controlled trial allocation was carried out by remote web-based randomisation (1 : 1), minimised on previous prostate surgery (radical prostatectomy or transurethral resection of the prostate), radiotherapy (or not, in relation to prostate surgery) and centre. Surgeons and participants were not blind to the treatment received. Non-randomised cohort allocation was participant and/or surgeon preference.Setting: The trial was set in 28 UK urological centres in the NHS.Participants: Participants were men with urodynamic stress incontinence after prostate surgery for whom surgery was deemed appropriate. Exclusion criteria included previous sling or artificial urinary sphincter surgery, unresolved bladder neck contracture or urethral stricture after prostate surgery, and an inability to give informed consent or complete trial documentation.Interventions: We compared male synthetic sling with artificial urinary sphincter.Main outcome measures: The clinical primary outcome measure was men’s reports of continence (assessed from questions 3 and 4 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) at 12 months post randomisation (with a non-inferiority margin of 15%). The primary economic outcome was cost-effectiveness (assessed as the incremental cost per quality-adjusted life-year at 24 months post randomisation).Results: In total, 380 men were included in the randomised controlled trial (n = 190 in each group), and 99 out of 100 men were included in the non-randomised cohort. In terms of continence, the male sling was non-inferior to the artificial urinary sphincter (intention-to-treat estimated absolute risk difference –0.034, 95% confidence interval –0.117 to 0.048; non-inferiorityp = 0.003), indicating a lower success rate in those randomised to receive a sling, but with a confidence interval excluding the non-inferiority margin of –15%. In both groups, treatment resulted in a reduction in incontinence symptoms (as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form). Between baseline and 12 months’ follow-up, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score fell from 16.1 to 8.7 in the male sling group and from 16.4 to 7.5 in the artificial urinary sphincter group (mean difference for the time point at 12 months 1.30, 95% confidence interval 0.11 to 2.49;p = 0.032). The number of serious adverse events was small (male sling group,n = 8; artificial urinary sphincter group,n = 15; one man in the artificial urinary sphincter group experienced three serious adverse events). Quality-of-life scores improved and satisfaction was high in both groups. Secondary outcomes that showed statistically significant differences favoured the artificial urinary sphincter over the male sling. Outcomes of the non-randomised cohort were similar. The male sling cost less than the artificial sphincter but was associated with a smaller quality-adjusted life-year gain. The incremental cost-effectiveness ratio for male slings compared with an artificial urinary sphincter suggests that there is a cost saving of £425,870 for each quality-adjusted life-year lost. The probability that slings would be cost-effective at a £30,000 willingness-to-pay threshold for a quality-adjusted life-year was 99%.Limitations: Follow-up beyond 24 months is not available. More specific surgical/device-related pain outcomes were not included.Conclusions: Continence rates improved from baseline, with the male sling non-inferior to the artificial urinary sphincter. Symptoms and quality of life significantly improved in both groups. Men were generally satisfied with both procedures. Overall, secondary and post hoc analyses favoured the artificial urinary sphincter over the male sling.Future work: Participant reports of any further surgery, satisfaction and quality of life at 5-year follow-up will inform longer-term outcomes. Administration of an additional pain questionnaire would provide further information on pain levels after both surgeries.Trial registration: This trial is registered as ISRCTN49212975.Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 26, No. 36. See the NIHR Journals Library website for further project information.

Background: Urinary stone disease affects 2–3% of the general population. Ureteric stones are associated with severe pain and can have a significant impact on a patient’s quality of life. Most ureteric stones are expected to pass spontaneously with supportive care; however, between one-fifth and one-third of patients require an active intervention. The two standard interventions are shockwave lithotripsy and ureteroscopic stone treatment. Both treatments are effective, but they differ in terms of invasiveness, anaesthetic requirement, treatment setting, number of procedures, complications, patient-reported outcomes and cost. There is uncertainty around which is the more clinically effective and cost-effective treatment.Objectives: To determine if shockwave lithotripsy is clinically effective and cost-effective compared with ureteroscopic stone treatment in adults with ureteric stones who are judged to require active intervention.Design: A pragmatic, multicentre, non-inferiority, randomised controlled trial of shockwave lithotripsy as a first-line treatment option compared with primary ureteroscopic stone treatment for ureteric stones.Setting: Urology departments in 25 NHS hospitals in the UK.Participants: Adults aged ≥ 16 years presenting with a single ureteric stone in any segment of the ureter, confirmed by computerised tomography, who were able to undergo either shockwave lithotripsy or ureteroscopic stone treatment and to complete trial procedures.Intervention: Eligible participants were randomised 1 : 1 to shockwave lithotripsy (up to two sessions) or ureteroscopic stone treatment.Main outcome measures: The primary clinical outcome measure was resolution of the stone episode (stone clearance), which was operationally defined as ‘no further intervention required to facilitate stone clearance’ up to 6 months from randomisation. This was determined from 8-week and 6-month case report forms and any additional hospital visit case report form that was completed by research staff. The primary economic outcome measure was the incremental cost per quality-adjusted life-year gained at 6 months from randomisation. We estimated costs from NHS resources and calculated quality-adjusted life-years from participant completion of the EuroQol-5 Dimensions, three-level version, at baseline, pre intervention, 1 week post intervention and 8 weeks and 6 months post randomisation.Results: In the shockwave lithotripsy arm, 67 out of 302 (22.2%) participants needed further treatment. In the ureteroscopic stone treatment arm, 31 out of 302 (10.3%) participants needed further treatment. The absolute risk difference was 11.4% (95% confidence interval 5.0% to 17.8%); the upper bound of the 95% confidence interval ruled out the prespecified margin of non-inferiority (which was 20%). The mean quality-adjusted life-year difference (shockwave lithotripsy vs. ureteroscopic stone treatment) was –0.021 (95% confidence interval 0.033 to –0.010) and the mean cost difference was –£809 (95% confidence interval –£1061 to –£551). The probability that shockwave lithotripsy is cost-effective is 79% at a threshold of society’s willingness to pay for a quality-adjusted life-year of £30,000. The CEAC is derived from the joint distribution of incremental costs and incremental effects. Most of the results fall in the south-west quadrant of the cost effectiveness plane as SWL always costs less but is less effective.Limitations: A limitation of the trial was low return and completion rates of patient questionnaires. The study was initially powered for 500 patients in each arm; however, the total number of patients recruited was only 307 and 306 patients in the ureteroscopic stone treatment and shockwave lithotripsy arms, respectively.Conclusions: Patients receiving shockwave lithotripsy needed more further interventions than those receiving primary ureteroscopic retrieval, although the overall costs for those receiving the shockwave treatment were lower. The absolute risk difference between the two clinical pathways (11.4%) was lower than expected and at a level that is acceptable to clinicians and patients. The shockwave lithotripsy pathway is more cost-effective in an NHS setting, but results in lower quality of life.Future work: (1) The generic health-related quality-of-life tools used in this study do not fully capture the impact of the various treatment pathways on patients. A condition-specific health-related quality-of-life tool should be developed. (2) Reporting of ureteric stone trials would benefit from agreement on a core outcome set that would ensure that future trials are easier to compare.Trial registration: This trial is registered as ISRCTN92289221.Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 26, No. 19. See the NIHR Journals Library website for further project information.

Background: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes.Objectives: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence.Design: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor.Setting: This trial was set in UK community and outpatient care settings.Participants: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence.Interventions: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions.Main outcome measures: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0–21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months.Results: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference –0.09, 95% confidence interval –0.92 to 0.75;p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time.Limitations: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women.Conclusions: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training.Future work: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes.Trial registration: Current Controlled Trial ISRCTN57746448.Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Background: New surgical approaches for apical prolapse have gradually been introduced, with few prospective randomised controlled trial data to evaluate their safety and efficacy compared with traditional methods.Objective: To compare surgical uterine preservation with vaginal hysterectomy in women with uterine prolapse and abdominal procedures with vaginal procedures in women with vault prolapse in terms of clinical effectiveness, adverse events, quality of life and cost-effectiveness.Design: Two parallel randomised controlled trials (i.e. Uterine and Vault). Allocation was by remote web-based randomisation (1 : 1 ratio), minimised on the need for concomitant anterior and/or posterior procedure, concomitant incontinence procedure, age and surgeon.Setting: UK hospitals.Participants: Uterine trial – 563 out of 565 randomised women had uterine prolapse surgery. Vault trial – 208 out of 209 randomised women had vault prolapse surgery.Interventions: Uterine trial – uterine preservation or vaginal hysterectomy. Vault trial – abdominal or vaginal vault suspension.Main outcome measures: The primary outcome measures were women’s prolapse symptoms (as measured using the Pelvic Organ Prolapse Symptom Score), prolapse-specific quality of life and cost-effectiveness (as assessed by incremental cost per quality-adjusted life-year).Results: Uterine trial – adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for uterine preservation was 4.2 (standard deviation 4.9) versus vaginal hysterectomy with a Pelvic Organ Prolapse Symptom Score of 4.2 (standard deviation 5.3) (mean difference –0.05, 95% confidence interval –0.91 to 0.81). Serious adverse event rates were similar between the groups (uterine preservation 5.4% vs. vaginal hysterectomy 5.9%; risk ratio 0.82, 95% confidence interval 0.38 to 1.75). There was no difference in overall prolapse stage. Significantly more women would recommend vaginal hysterectomy to a friend (odds ratio 0.39, 95% confidence interval 0.18 to 0.83). Uterine preservation was £235 (95% confidence interval £6 to £464) more expensive than vaginal hysterectomy and generated non-significantly fewer quality-adjusted life-years (mean difference –0.004, 95% confidence interval –0.026 to 0.019). Vault trial – adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for an abdominal procedure was 5.6 (standard deviation 5.4) versus vaginal procedure with a Pelvic Organ Prolapse Symptom Score of 5.9 (standard deviation 5.4) (mean difference –0.61, 95% confidence interval –2.08 to 0.86). The serious adverse event rates were similar between the groups (abdominal 5.9% vs. vaginal 6.0%; risk ratio 0.97, 95% confidence interval 0.27 to 3.44). The objective anterior prolapse stage 2b or more was higher in the vaginal group than in the abdominal group (odds ratio 0.38, 95% confidence interval 0.18 to 0.79). There was no difference in the overall prolapse stage. An abdominal procedure was £570 (95% confidence interval £459 to £682) more expensive than a vaginal procedure and generated non-significantly more quality-adjusted life-years (mean difference 0.004, 95% confidence interval –0.031 to 0.041).Conclusions: Uterine trial – in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between uterine preservation and vaginal hysterectomy. Vault trial – in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between an abdominal and a vaginal approach.Future work: Long-term follow-up for at least 6 years is ongoing to identify recurrence rates, need for further prolapse surgery, adverse events and cost-effectiveness.Trial registration: Current Controlled Trials ISRCTN86784244.Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 24, No. 13. See the National Institute for Health Research Journals Library website for further project information.