The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation
Carol BuggeRohna KearneyMelanie DembinskyAethele KhundaMargaret GrahamWael AgurSuzanne BreemanLucy DwyerAndrew EldersMark ForrestKirsteen GoodmanKaren GuerreroChristine HemmingHelen MasonDoreen McClurgLynn MeloneJohn NorrieRanee ThakarSuzanne Hagen
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Abstract Background Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women’s condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants’ and healthcare professionals’ experiences. Methods The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/ n = 36), women who declined trial participation but agreed to interview (non-randomised women) ( n = 20) and healthcare professionals recruiting to the trial ( n ~ 17) and delivering self-management and clinic-based care ( n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12–18). All participating centres will be asked to record one or two self-management teaching appointments ( n = 30) and self-management 2-week follow-up telephone calls ( n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan. Discussion The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs. Trial registration ISRCTN62510577 . Registered on 6 October 2017.Keywords:
Pessary
Self-Management
Abstract Objective: The primary outcome of this study was the efficacy of the Gellhorn pessary in patients with advanced pelvic organ prolapse (POP) who failed to retain a ring with support pessary, and the secondary outcome is the related factors that influence its successful use. Methods: Between May 2015 and May 2016, women with POP quantification stage III to IV, who initially failed to place a ring with a support pessary, but were then successfully fitted with a Gellhorn pessary, were included. We performed independent-sample t tests, nonparametric tests, chi-square tests, and logistic regressions for data analysis. Results: A total of 82.3% (65/79) participants were successfully fitted with a Gellhorn pessary at the fitting. At 3 months, 46 participants continued to use the pessary, whereas 19 discontinued use, indicating a success rate of 70.8% (46/65). All the participants were satisfied with their pessary. More than half experienced mild complications such as vaginal erosion or discharge. The presence of predominant prolapse in the anterior wall may be an influential factor for successful pessary use ( P < 0.01), whereas a higher body mass index or a history of prior hysterectomy or prolapse surgery was associated with discontinuation. Conclusion: For patients with advanced POP who failed to retain a ring with support pessary, the Gellhorn pessary can be offered as a second option. Body mass index, the presence of predominant anterior wall prolapse, and a previous hysterectomy or prolapse surgery may be potential factors influencing the outcomes of Gellhorn pessary use.
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This study was conducted to investigate attitudes toward pessary use in Thai women with pelvic organ prolapse (POP).Ninety Thai women with symptomatic POP without any history of previous prolapse treatment were recruited. Participants completed a questionnaire about attitudes toward pessary use in Thai language. Patient characteristics and decision-making factors were identified.Forty eight women (53.3%) decided to use a pessary. Most respondents felt that pessary use would improve emotional status (56.2%), pain (52.0%) and quality of life (75%). The opinions of family members and post-application bleeding, discharge, irritation and pain were important factors in decision-making.Many Thai women with POP prefer a pessary. Their decision is influenced by opinions of family members and complications of pessary use. Counseling about the advantages and uncommon complications of pessary use should be provided to both patients and family members to improve higher pessary acceptance.
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To evaluate a simplified protocol for pessary management.Women with symptomatic pelvic organ prolapse who opted for pessaries were enrolled in a prospective simplified protocol for pessary management. After the initial pessary fitting, they were seen at 2 weeks for reexamination and thereafter at 3- to 6-month intervals.One hundred ten women (mean age 65 years) were enrolled, and 81 (74%) of them were fitted successfully with a pessary. Life-table analysis showed that 66% of those who used a pessary for more than 1 month were still users after 12 months and 53% were still users after 36 months. The severity of pelvic prolapse did not predict the likelihood of pessary failure except in cases of complete vaginal eversion. Patients complaining of stress incontinence were less likely to have a successful pessary fitting and more likely to opt for surgery. Current hormone use and substantial perineal support do not predict greater likelihood of pessary fitting success. No serious complications from using the pessary were observed in the study sample.Stringent guidelines calling for frequent pelvic examinations during pessary use can be relaxed safely. Pessaries can be offered as a safe long-term option for the management of pelvic prolapse.
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Pelvic organ prolapse is a significant quality of life issue for many women. Prolapse can be managed effectively with a mechanical device called a pessary therefore many women choose this as a conservative treatment option. Despite the extent to which pessaries are used in the UK, there are no clear guidelines regarding the training required for pessary practitioners. This article reviews literature related to pessary practitioner training. Methods: 13 publications were reviewed. Results: eight themes were identified, namely ‘prevalence of pessary training’, ‘type of pessary training’, confidence in pessary care provision’, ‘impact on pessary care’, ‘skills and knowledge required to be a pessary practitioner’, ‘barriers’, ‘speciality of pessary care providers’, and ‘ongoing support’. Conclusion: at present practitioners report a lack of pessary training, which impacts on care. Effective training includes didactic learning of agreed knowledge requirements, practice of clinical skills and ongoing support.
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