Table 5.
Reference | Study design | Cases | Studied intervention | Methods | Endpoint | Results |
---|---|---|---|---|---|---|
Pelvic floor muscle training | ||||||
Sjostrom (2013) [22]a | Randomized controlled trial | 124 | Internet-based treatment program | Both interventions focused mainly on PFMT. The Internet group received 3-mo continuous e-mail support from a urotherapist, whereas the postal group trained on their own. Follow-up was performed after 4 mo via self-assessed postal questionnaires | The primary outcomes were symptom severity (ICIQ-UI SF) and condition-specific quality of life (ICIQ-LUTSqol). Secondary outcomes were the Patient Global Impression of Improvement, health-specific quality of life (EQ-VAS), use of incontinence aids, and satisfaction with treatment | The mean changes in ICIQ-UI SF were 3.4 ± 3.4 for the Internet group and 2.9 ± 3.1 for the postal group (p = 0.27) after 4 mo. The mean changes in ICIQ-LUTSqol were 4.8 ± 6.1 for the Internet group and 4.6 ± 6.7 the for postal group (p = 0.52). The proportions of participants perceiving that they were much or very much improved were similar in both intervention groups (69.8% in both arms) |
126 | Program sent by post | After treatment, more participants in the Internet group had either stopped using or reduced their usage of UI aids (59.5% vs 41.4%, p = 0.02) | ||||
In the Internet group, 84.8% of participants experienced the treatment program as “good” or “very good”, compared with 62.9% in the postal group (p < 0.001) | ||||||
Carrion Perez (2015) [25] | Randomized controlled trial | 10 | New telerehabilitation device for stress urinary incontinence | 1. Pelvic floor muscle training: 5 sessions of 30 min for 2 wk. 2. Training in the use of the telerehabilitation device (3 sessions of 30 min). The device consists of a vaginal probe that transmits wirelessly (Bluetooth) variations of pressure. The computer application allows the patient to visualize the correct execution of the exercise. 3. Home treatment with the telerehabilitation device using a personalized program. Monthly monitoring by professionals |
Outcome measures (baseline and 3 mo) overall and specific quality of life: ICIQ-UI SF and King’s Health Questionnaire, bladder diary, perineometry, satisfaction with the program and degree of compliance | There was no statistically significant difference for any outcome measures between groups at the end of the follow-up. The change in perineometry values at baseline and after the intervention was significant in the experimental group (23.06–32.00, p = 0.011). No group in this study had any serious adverse effects |
9 | Conventional rehabilitation treatment | 1. PFMT as in the intervention arm 2. Biofeedback: 10 sessions 3. Home treatment: personalized written program in which exercise with a daily frequency is specified |
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Sjostrom (2015) [27]a | Randomized controlled trial | 124 | Internet-based treatment program | Both Interventions focused mainly on PFMT. The Internet group received 3-mo continuous e-mail support from a urotherapist, whereas the postal group trained on their own. Follow-up was performed after 1 and 2 yr via self-assessed postal questionnaires | The primary outcomes were symptom severity (ICIQ-UI SF) and condition-specific quality of life (ICIQ-LUTSqol). Secondary outcomes were the Patient Global Impression of Improvement, health-specific quality of life (EQ-VAS), use of incontinence aids, and satisfaction with treatment | The mean changes in ICIQ-UI SF were 3.7 ± 3.3 for the Internet group and 3.2 ± 3.4 for the postal group (p = 0.47) after 1 yr, and 3.6 ± 3.5 for the internet group and 3.4 ± 3.3 for the postal group (p = 0.79) after 2 yr. The mean changes in ICIQ-LUTSqol were 5.5 ± 6.5 for the Internet group and 4.7 ± 6.5 for the postal group (p = 0.55) after 1 yr, and 6.4 ± 6.0 for the Internet group and 4.8 ± 7.6 for the postal group (p = 0.28) after 2 yr. The proportions of participants perceiving that they were much or very much improved were similar in both intervention groups after 1 yr (31.9% vs 33.8%, p = 0.82), but after 2 yr significantly more participants in the Internet group reported this degree of improvement (39.2% vs 23.8%, p = 0.03). Health-specific QoL improved significantly in the Internet group after 2 yr (mean change in EQ-VAS, 3.8 ± 11.4, p = 0.005) |
126 | Program sent by post | |||||
Asklund (2017) [33]b | Randomized controlled trial | 62 | Tat mobile app with a treatment program for SUI, focused on PFMT | Adoption of an app focused on PFMT exercises and also containing information that described SUI, pelvic floor, and lifestyle factors related to incontinence | Three-month changes from baseline in ICIQ-UI SF and ICIQ-LUTSqol | At follow-up, the app group reported larger reductions in ICIQ-UI SF score (3.9 vs 0.9, p < 0.001) and in the mean ICIQ-LUTSqol score (4.8 vs 0.7, p = 0.005). |
61 | Standard | Standard PFMT | The follow-up PGI-I results showed that app group participants reported much improved or very much improved urinary incontinence more often than control group participants (55.7% vs 5%, p < 0.001). Concerning weekly leakage episodes, 56.5% of the app group and 29.5% of the control group reported either no leakage or ≥50% fewer leakage episodes than at baseline (between-group p = 0.005). The app group reduced the use of incontinence aids significantly (p < 0.001). At follow-up, the groups were significantly different in the use of incontinence aids (p = 0.023). Patient satisfaction with the app was “good” or “very good” in 96.7% of the app group. Two-thirds of the app group (66.7%) reported satisfaction with the treatment outcome, and 21.7% planned to seek additional treatment for incontinence | |||
Hoffman (2017) [36]b | Secondary analysis of a randomized controlled trial | 62 | Treating SUI with pelvic floor muscle training supported by the mobile app | Follow up the women in the app group 2 yr after the initial trial with the same primary outcomes for symptom severity (ICIQ-UI SF) and condition-specific quality of life (ICIQ-LUTSqol) and compared the scores with those at baseline | Two-year changes from baseline in ICIQ-UI SF and ICIQ-LUTSqol | The mean decreases in ICIQ-UI SF and ICIQ-LUTSqol after 2 yr were 3.1 and 4.0, respectively. Of the 46 women, four (8.7%) rated themselves as very much better, nine (19.6%) as much better, and 16 (34.8%) as a little better. The use of incontinence protection products decreased significantly (p = 0.04), and the proportion of women who felt that they could contract their pelvic muscles correctly increased from 14/46 (30.4%) at baseline to 31/46 (67.4%) at follow-up (p < 0.001) |
Follow-up after surgical procedures | ||||||
Jefferis (2016) [28] | Clinical audit | 356 | Telephone consultations after TVT sling surgery | Cases identified from the BSUG database then had their case notes reviewed. Patients having additional surgery were excluded from the analysis | To report 5-yr experience of telephone consultations after TVT sling surgery | A total of 262 patients were initially followed up via telephone; the remaining 94 were seen in a conventional outpatient clinic setting. Of the 262 patients followed up by telephone, 28 (10%) subsequently required review in an outpatient clinic for a variety of reasons |
Balzarro (2020) [50] | Prospective comparative | A total of 215 women following MUS placement for SUI | One-year follow-up telephonic interview using a checklist and validated questionnaires, followed by a standard outpatient clinic visit 7–12 d later including an interview, validated questionnaires, objective examination, and score satisfaction with the telephone follow-up | PGI-I and PPBC questionnaires were administered during the telephone call; at the office follow-up evaluations PGI-I, PPBC, vaginal examination, and a bladder stress test with fluid volumes of 300 ml | To determinate the feasibility, reliability, and patient satisfaction of telephonic follow-up in women treated for SUI or POP | SUI recurrence was 19.1% and 11.6% at the telephone and office follow-up, respectively. De novo urgency urinary incontinence rate was 7.5%. Telephone follow-up was able to detect POP recurrence and related symptoms. Tape and mesh extrusions were detected only at the objective evaluation: 1.9% and 4.4%, respectively. No difference was found at the questionnaires. Satisfaction with the telephone follow-up was high |
AVW = anterior vaginal wall; EQ-VAS = EQ-visual analog scale; ICIQ-LUTSqol = International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life; ICIQ-UI SF = International Consultation on Incontinence Questionnaire Short Form; MUS = middle urethral sling; PFMT = pelvic floor muscle training; PGI-I = Patient Global Impression of Improvement; POP = pelvic organ prolapse; PPBC = Patient Perception of Bladder Condition; RCT = randomized controlled trial; SUI = stress urinary incontinence; TVT = tension-free vaginal tape; UI = urinary incontinence.
Two reports of the same RCTs at different follow-up durations.
Two reports of the same RCTs (main report and evaluation of the intervention arm at longer follow-up duration).