Panman 2016.
| Study characteristics | ||
| Methods |
Design: parallel group RCT Dates study conducted: October 2009 to December 2012 |
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| Participants |
Setting: multicentre (women recruited from 20 general practices) Country: the Netherlands Number of participants: 162 women with prolapse at or beyond hymen (POP‐Q measured) Mean age: PFMT group 65.6 (SD 6.4); pessary group 64.9 (SD 7.4) Prolapse staging: PFMT group: stage II 77.5% (n = 62); stage III 22.5% (n = 18). Pessary group: stage II 70.7% (n = 58); stage III 29.3% (n = 24). Prolapse compartment: PFMT group: anterior 31.3% (n = 25), posterior 3.8% (n = 3), apical 0% (n = 0), anterior and posterior 32.5% (n = 26), anterior and apical 10% (n = 8), posterior and apical 2.5% (n = 2), anterior and posterior and apical 20% (n = 16) Pessary group: anterior 24.7% (n = 20), posterior 0% (n = 0), apical 0% (n = 0), anterior and posterior 28.4% (n = 23), anterior and apical 23.5% (n = 19), posterior and apical 0% (n = 0), anterior and posterior and apical 23.5% (n = 19) Inclusion criteria: women aged 55 years and older, GP registered, self‐identified prolapse symptoms (using screening tool), prolapse at or beyond hymen using POP‐Q Exclusion criteria: current prolapse treatment (or within the last year for PFMT, pessary or surgery), current treatment for gynaecological or urological disorder, current gynaecological or urological malignancy, severe/terminal illness, inability to visit GP office, cognitive impairment, inability to understand complete Dutch questionnaires, stage IV prolapse |
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| Interventions |
Group I (n = 80): PFMT. Delivered by a registered pelvic physiotherapist registered with Dutch Pelvic Physio Association. Started with explanation of pelvic floor function, if unable to contract taught this first, women did exercises during physiotherapy contact and at home three to five times a week and two to three times a day. All participants started with same exercise regimen and then individual adaptation in line with normal practice (included being able to use electrical stimulation). All taught the knack. Attention paid to lifestyle and toileting habits. At three‐month follow‐up all PFMT group received a leaflet with information and advice on lifestyle and continuing PFMT. Group II (n = 82): pessary. Fitted by quote: "trained research physician" (n = 4). Two‐week trial of pessary with refit at two weeks if necessary (maximum of three refits); first ring, then ring with support and then Shaatz or Gellhorn (all silicone). Follow‐up started as soon as successful fit achieved. Additional visits (to GP or research physician) to clean pessary and monitor side effects every three months. Topical oestrogen used for vaginal decubitus. |
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| Outcomes |
Primary outcome: distress caused by pelvic floor symptoms measured by PFDI‐20 Secondary outcomes: three subscales of PFDI‐20, condition‐specific and general quality of life, sexual function, pelvic floor muscle function, POP‐Q, post void residual volume, patients' perception of improvement, costs |
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| Notes |
Funding source: quote: "funded by the Netherlands Organisation for Health Research and Development (ZonMw), project number 4201.1001"; "The funding organization had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication." Declarations of interest: quote: "The authors declare no conflict of interest." There is both the main paper that presented an intention‐to‐treat and per protocol analysis. The full trial protocol is published (Panman 2016) .Data for intention‐to‐treat analysis available in main paper, plus one conference abstract about the completed case analysis at three months (those with unsuccessful pessary fitting excluded). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised in a 1:1 ratio using external (remotely accessed) computerised system in variable block size |
| Allocation concealment (selection bias) | Low risk | Enrolling physician blind to block size and allocation sequence. Allocation using remotely accessed computer system. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Patients and treating health professionals not blinded to treatment allocation. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Research physicians were not blinded to allocation and outcomes may have been influenced by their knowledge of allocation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 70/80 in PFMT group and 74/82 in pessary group at 24 months |
| Selective reporting (reporting bias) | Low risk | Data are presented across outcomes |
| Other bias | Low risk | None |
GP: general practitioner PFDI‐20: Pelvic Floor Disability Index PFIQ: Pelvic Floor Impact Questionnaire PFMT: pelvic floor muscle training POP: pelvic organ prolapse POP‐Q: Pelvic Organ Prolapse Quantification RCT: randomised controlled trial SD: standard deviation SF36: Short Form 36 UDI: Urinary Distress Index VAS: visual analogue scale