Quadri 1985.
| Methods | RCT, method unspecified | |
| Participants | 103 women with mixed incontinence (urethral sphincter incompetence in all, detrusor instability in I,12/55 ; II,7/48), moderate (I,25; II, 34) to severe (I, 30; II, 14) prolapse. Age: I, 58 yr (range 38‐76); II, 54 (36‐75) Previous incontinence surgery (anterior vaginal repair): I, 7/55; II, 2/48 Additional operations during trial: I, 55 had vaginal hysterectomy, 52 had posterior repair; II, 43 had abdominal hysterectomy, 2 had vaginal hysterectomy, 10 had Douglas obliteration, 15 had posterior repair | |
| Interventions | I: Retropubic colposuspension (48)
II: Anterior colporrhaphy (55) Techniques not described Surgeon not mentioned Other co‐interventions allowed |
|
| Outcomes | Number cured
Number with prolapse Cure not defined Incontinence at 3 m: I, 17/55; II, 16/48 Incontinence persisted at 12 m (failed): I, 11/55; II, 8/48. Further 5/55 and 4/48 later 'cured' using drugs Incontinence at 5 years (subjective): I: 8/50, II: 4/49 Incontinence at 5 years (objective): I: 6/50, II: 4/49 Prolapse recurred: I, 3/55; II, 13/48 [Type of prolapse: I, moderate cystocele 2, vaginal cuff 1; II, moderate to severe urethrocystocele 7, vaginal cuff 6] Later prolapse recurrence: I: 1/50, II: 16/49 Dyspareunia amongst sexually active: I: 30%, II: 13% P < 0.05 (number not given) Vaginal length: I: 4.9 cm (SD 1.7), II: 7.3 (1) |
|
| Notes | Reported in 3 conference abstracts only, further data not available. Recruitment period, data and numbers slightly different in each abstract Follow up 3 months, 3 years and 5 years. For recurrent prolapse, data from 1993 abstract used (at 5 year follow up) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly selected to a surgical schedule" |
| Allocation concealment (selection bias) | Unclear risk | not mentioned |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | not mentioned |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | no withdrawals described |
| Other bias | Unclear risk | information available in abstract only; no full text publication available |