Urinary Incontinence

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.

The effectiveness of the various behavioural approaches in the management of urinary incontinence (UI) in individuals post-stroke is not well studied. This review presents 8 RCTs, of which 6 are high quality RCTs (2 of which are secondary analyses of one RCT) and 2 are fair quality RCTs. Of the studies included, 1 study examined patients in the acute phase of stroke recovery and 1 study included patients in the subacute phase of recovery; all remaining studies included patients across recovery phases (classified here as ‘Phase of stroke recovery not specific to one period’).

Please click here to see the Authors’ Results Table.

Acute phase - Compensatory rehabilitation

Functional independence/ADLsEffective2a

One fair quality RCT (Wikander et al., 1998) investigated the effect of a rehabilitation program based on the Functional Independence Measure (FIM) on functional independence/activities of daily living (ADLs) in patients with acute stroke. This fair quality RCT randomized patients to receive FIM-based rehabilitation or Bobath-based rehabilitation for the duration of hospitalisation (average 83 and 75 days respectively). ADLs were measured by the Katz ADL Index at baseline and at post-treatment. Significant between-group differences in ADLs were seen at post-treatment, favoring FIM-based rehabilitation vs. the Bobath approach.

Conclusion: There is limited evidence (Level 2a) from 1 fair quality RCT that rehabilitation based on the FIM is more effective than a comparison intervention (Bobath approach) in improving functional independence/ADLs in patients with acute stroke.

MobilityEffective2a

One fair quality RCT (Wikander et al., 1998) investigated the effect of a rehabilitation program based on the Functional Independence Measure (FIM) on transfers and mobility among patients with acute stroke. This fair quality RCT randomized patients to receive FIM-based rehabilitation or Bobath-based rehabilitation for the duration of their hospitalisation (average 83 and 75 days respectively). Mobility was measured at baseline and at post-treatment using a non-standardised 3-point rating scale during clinical observation of transfers (bed to wheelchair, wheelchair to toilet), wheelchair use and walking. Significant between-group differences in transfers and wheelchair use (but not walking scores) were seen at post-treatment, favoring FIM-based rehabilitation vs. the Bobath approach.

Conclusion: There is limited evidence (Level 2a) from 1 fair quality RCT that FIM-based rehabilitation is more effective than a comparison intervention (Bobath approach) in improving transfers and wheelchair skills (but not walking ability) in patients with acute stroke.

Urinary continenceEffective2a

One fair quality RCT (Wikander et al., 1998) investigated the effect of a rehabilitation program based on the Functional Independence Measure (FIM) on urinary incontinence in patients with acute stroke. This fair quality RCT randomized patients to receive FIM-based rehabilitation or Bobath-based rehabilitation for the duration of their hospitalisation (average 83 and 75 days respectively). Urinary continence was measured by the FIM-G (urinary incontinence) at baseline and at post-treatment. Significant between-group differences in urinary continence were seen at post-treatment, favoring FIM-based rehabilitation vs. the Bobath approach.

Conclusion: There is limited evidence (Level 2a) from 1 fair quality RCT that FIM-based rehabilitation is more effective than a comparison intervention (Bobath approach) in improving urinary continence in patients with acute stroke.

Well-beingEffective2a

One fair quality RCT (Wikander et al., 1998) investigated the effect of rehabilitation based on the Functional Independence Measure (FIM) on well-being in patients with acute stroke. This fair quality RCT randomized patients to receive FIM-based rehabilitation or Bobath-based rehabilitation for the duration of hospitalisation (average 83 and 75 days respectively). Well-being was measured by the Psychological General Well-Being Index at baseline and at post-treatment. Significant between-group differences in well-being were seen at post-treatment, favoring FIM-based rehabilitation vs. the Bobath approach.

Conclusion: There is limited evidence (Level 2a) from 1 fair quality RCT that rehabilitation based on the FIM is more effective than a comparison intervention (Bobath approach) in improving well-being in patients with acute stroke.

Subacute phase - Systematic voiding program

Functional independence/ADLsNot effective1b

One high quality RCT (Thomas et al., 2014) investigated the effect of a systematic voiding program (SVP) on functional independence/activities of daily living (ADLs) in patients with subacute stroke. This high quality RCT randomized patients to receive a SVP, a supported SVP, or usual continence care for the duration of hospitalization. Functional independence/ADLs were measured by the Barthel Index at baseline, 6 weeks and 12 weeks post-stroke. No significant between-group differences in functional independence/ADLs were found between any group at either time point post-treatment.

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT that a systematic voiding program (SVP) is not more effective than a comparison intervention (usual continence care) in improving functional independence/ADLs in patients with subacute stroke.

Health-related quality of lifeNot effective1b

One high quality RCT (Thomas et al., 2014) investigated the effect of a systematic voiding program (SVP) on health-related quality of life in patients with subacute stroke. This high quality RCT randomized patients to receive a SVP, a supported SVP or usual continence care for the duration of hospitalization. Health-related quality of life was measured by the EuroQOL (mobility, self-care, usual activity, pain or discomfort, anxiety or depression) and the Incontinence Quality of Life Instrument at baseline (EuroQOL only), 6 weeks and 12 weeks post-stroke. There were no significant between-group differences between any group on either measure of health-related quality of life at either time point post-treatment.

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT that a systematic voiding program (SVP) is not more effective than a comparison intervention (usual continence care) in improving health-related quality of life in patients with subacute stroke.

Urinary incontinenceNot effective1b

One high quality RCT (Thomas et al., 2014) investigated the effect of a systematic voiding program (SVP) on urinary incontinence symptoms in patients with subacute stroke. This high quality RCT randomized patients to receive a SVP, a supported SVP, or usual continence care for the duration of hospitalization. Urinary incontinence was measured by the International Consultation on Incontinence Questionnaire – Short Form (ICIQ-SF), the Incontinence Severity Index (ISI), and the Leicester Urinary Symptom Questionnaire at baseline (ICIQ-SF and ISI only), 6 weeks and 12 weeks post-stroke. There were no significant between-group differences in urinary incontinence between any group at either time point post-treatment.

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT that a systematic voiding program (SVP) is not more effective than a comparison intervention (usual continence care) in improving urinary continence in patients with subacute stroke.

Phase of stroke recovery not specific to one period - Pelvic floor muscle training

Health-related quality of lifeNot effective1b

One high quality RCT (Tibaek et al., 2004, 2007) investigated the effects of pelvic floor muscle training on health-related quality of life in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive pelvic floor muscle training and education (including home and group exercises) or no training/education. Health-related quality of life was measured by the Short-Form 36 (SF-36) and the Incontinence Impact Questionnaire (IIQ) at baseline and at post-treatment (12 weeks – Tibaek et al., 2004) and again at 6-month follow-up (Tibaek et al., 2007). There were no significant between-group differences on either measure of health-related quality of life at any time point.  

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT that pelvic floor muscle training and education is not more effective than no training/education in improving health-related quality of life in patients with stroke.

Pelvic floor muscle activityConflicting4

Two high quality RCTs (Tibaek et al., 2005, Shin et al., 2016) investigated the effect of pelvic floor muscle training on pelvic floor muscle activity in patients with stroke.

The first high quality RCT (Tibaek et al., 2005) randomized patients with subacute/chronic stroke to receive pelvic floor muscle training and education (including home and group exercises) or no training/education. Pelvic floor muscle activity (function, strength, dynamic endurance, static endurance) were measured by vaginal palpation of the pelvic floor muscle at baseline and at post-treatment (12 weeks). At post-treatment there was a significant between-group difference for one parameter only (pelvic floor muscle dynamic endurance), favoring pelvic floor muscle training vs. no training/education.

The second high quality RCT (Shin et al., 2016) randomized patients with subacute/chronic stroke to receive pelvic floor muscle training or no training. Pelvic floor muscle activity (resting, contracting, relaxed) was measured at baseline and at post-treatment (6 weeks). Significant between-group differences in pelvic floor muscle activity (resting, contracting, relaxed) were seen at post-treatment, favoring pelvic floor muscle training vs. no training. 

Conclusion: There is conflicting evidence (Level 4) regarding the effectiveness of pelvic floor muscle training in improving pelvic floor muscle activity in patients with stroke. While 1 RCT found found significant differences on only one measure of pelvic floor muscle activity (dynamic endurance), a second RCT found that pelvic floor muscle training was more effective than no training in improving pelvic floor muscle activity in patients with stroke.

Urinary incontinenceEffective1a

Two high quality RCTs (Tibaek et al., 2005, Shin et al., 2016) investigated the effect of pelvic floor muscle training on urinary incontinence symptoms in patients with stroke.

The first high quality RCT (Tibaek et al., 2005) randomized patients with subacute/chronic stroke to receive pelvic floor muscle training and education (including home and group exercises) or no training/education. Urinary incontinence symptoms (frequency of voiding over 24 hours, during the day and during the night; number of incontinence episodes; number of incontinence pads used; 24-hour Home Pad Test) were measured at baseline and at post-treatment (12 weeks). Significant between-group differences in two measures of incontinence (frequency of daytime voiding; 24-hour Home Pad Test) were seen at post-treatment, favoring pelvic floor muscle training vs. no training/education.

The second high quality RCT (Shin et al., 2016) randomized patients with subacute/chronic stroke to receive pelvic floor muscle training no training. Urinary incontinence symptoms were measured by the Bristol Female Urinary Symptoms Questionnaire (inconvenience in activities of daily living, urinary symptoms) at baseline and at post-treatment (6 weeks). Significant between-group differences were found at post-treatment, favoring pelvic floor muscle training vs. no training. 

Conclusion: There is strong evidence (Level 1a) from 2 high quality RCTs that pelvic floor muscle training is more effective than no training in improving urinary incontinence symptoms in patients with stroke.

Vaginal muscle strengthEffective1b

One high quality RCT (Shin et al., 2016) investigated the effect of pelvic floor muscle training on vaginal muscle strength in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive pelvic floor muscle training or no pelvic floor muscle training. Vaginal muscle strength was measured according to maximal vaginal squeeze pressure by perineometer at baseline and at post-treatment (6 weeks). Significant between-group differences in maximal vaginal squeeze pressure were found at post-treatment, favoring pelvic floor muscle training vs. no training.

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT that pelvic floor muscle training is more effective than no training in improving vaginal muscle strength (maximal vaginal squeeze pressure) in patients with stroke.

Phase of stroke recovery not specific to one period - Timed voiding

Urinary incontinenceConsensus3

There are no studies addressing the efficacy of timed voiding for urinary incontinence (UI) in patients with stroke. Two clinical practice guidelines (CPGs) ( Fantl et al., 1996Abrams et al., 2010) recommend timed voiding for cooperative and mobile stroke patients. These guidelines are based on results of randomized controlled trials (RCTs) in non-stroke neurogenic UI patients and from expert opinion.

Conclusion: There is a consensus opinion (Level 3) that timed voiding should be implemented for the rehabilitation of urinary incontinence in cooperative and mobile individuals with stroke.

Phase of stroke recovery not specific to one period - Transcutaneous electrical nerve stimulation (TENS)

Functional independence/ADLsEffective1b

One high quality RCT (Liu et al., 2016) and one fair quality RCT (Guo et al., 2014) investigated the effect of transcutaneous electrical nerve stimulation (TENS) on functional independence/activities of daily living (ADLs) in patients with stroke.

The high quality RCT (Liu et al., 2016) randomized patients with subacute/chronic stroke to receive TENS at 20 Hz, TENS at 75 Hz, or no TENS. Functional independence/ADLs were measured by the Barthel Index at baseline and at post-treatment (90 days). There were significant between-group differences in functional independence/ADLs at post-treatment, favoring TENS at 20 Hz vs. 75 Hz, TENS at 20 Hz vs. no therapy, and TENS at 75 Hz vs. no therapy.

The fair quality RCT (Guo et al., 2014) randomized patients with acute/subacute stroke to receive TENS at 75 Hz or no TENS. Functional independence/ADLs were measured by the Barthel Index (bowels, bladder, grooming, toilet use, feeding, transfers, mobility, dressing, stairs, bathing scores) at baseline and at post-treatment (60 days). Significant between-group differences were found for several measures of functional independence/ADLs (Barthel Index – bowels, bladder, toilet use, transfers, mobility, stairs, bathing) at post-treatment, favoring TENS at 75 Hz vs. no TENS.

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT and 1 fair quality RCT that TENS is more effective than no TENS in improving functional independence/ADLs in patients with stroke. Further, a high quality RCT found that TENS applied at 20Hz was more effective than 75Hz.

Overactive bladder symptomsEffective1b

One high quality RCT (Liu et al., 2016) and one fair quality RCT (Guo et al., 2014) investigated the effect of transcutaneous electrical nerve stimulation (TENS) on overactive bladder symptoms in patients with stroke.

The high quality RCT (Liu et al., 2016) randomized patients with subacute/chronic stroke to receive TENS at 20 Hz, TENS at 75 Hz or no TENS. Overactive bladder symptoms were measured by the Overactive Bladder Symptom Score (OABSS total score) at baseline and at post-treatment (90 days). There were significant between-group differences in OABSS scores at post-treatment, favoring TENS at 20 Hz vs. vs. 75 Hz, TENS at 20 Hz. vs. no TENS, and favoring TENS at 75 Hz vs. no TENS.

The fair quality RCT (Guo et al., 2014) randomized patients with acute/subacute stroke to receive TENS at 75 Hz or no TENS. Overactive bladder symptoms were measured by the OABSS (daily micturition, nocturia, urgent urination, urge urinary incontinence scores) at baseline and at post-treatment (60 days). Significant between-group differences were found for all OABSS scores at post-treatment, favoring TENS vs. no TENS.

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT and 1 fair quality RCT that TENS is more effective than no TENS in improving overactive bladder symptoms in patients with stroke. Further, a high quality RCT found that TENS applied at 20Hz was more effective than TENS at 75Hz.

Urodynamic parametersEffective1b

One high quality RCT (Liu et al., 2016) and one fair quality RCT (Guo et al., 2014) investigated the effect of transcutaneous electrical nerve stimulation (TENS) on urodynamic parameters in patients with stroke.

The high quality RCT (Liu et al., 2016) randomized patients with subacute/chronic stroke to receive TENS at 20 Hz, TENS at 75 Hz or no TENS. Urodynamic parameters (maximum cystometric capacity, detrusor pressure, maximum flow rate) were measured at baseline and at post-treatment (90 days). There were significant between-group differences in all urodynamic parameters at post-treatment, favoring TENS at 20 Hz vs. vs. 75 Hz, TENS at 20 Hz. vs. no TENS, and favoring TENS at 75 Hz vs. no TENS.

The fair quality RCT (Guo et al., 2014) randomized patients with acute/subacute stroke to receive TENS at 75 Hz or no TENS. Urodynamic parameters (maximum cystometric capacity, detrusor pressure, maximum flow rate) were measured at baseline and at post-treatment (60 days). Significant between-group differences were found for all urodynamic parameters at post-treatment, favoring TENS vs no TENS.

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT and 1 fair quality RCT that TENS is more effective than no TENS in improving urodynamic parameters in patients with stroke. Moreover, a high quality RCT found that TENS at 20Hz was more effective than TENS at 75Hz.

Voiding parametersEffective1b

One high quality RCT (Liu et al., 2016) investigated the effect of transcutaneous electrical nerve stimulation (TENS) on voiding parameters in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive TENS at 20 Hz, TENS at 75 Hz, or no TENS. Voiding parameters (24-hour frequency, average voided volume, 24-hour incontinence episodes) were measured at baseline and at post-treatment (90 days). There were significant between-group differences on all voiding parameters at post-treatment, favoring TENS at 20 Hz vs. vs. 75 Hz, TENS at 20 Hz. vs. no TENS, and favoring TENS at 75 Hz vs. no TENS.

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT that TENS is more effective than no TENS in improving voiding parameters in patients with stroke. Further, results from the high quality RCT showed that TENS at 20Hz is more effective than TENS at 75Hz.


Reference list:

Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. (2010). Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40.
https://www.ncbi.nlm.nih.gov/pubmed/20025020

Fantl, J. A., Newman, D. K., Colling, J., DeLancey, J. O. L., Keeys, C., Loughery, R., et al. (1996, March). Urinary incontinence in adults: Acute and chronic management (Clinical Practice Guideline, No. 2, 1996 Update, AHCPR Publication No. 96-0682). Rockville, MD: U.S. Department of Health and Human Services. Public Health Service, Agency for Health Care Policy and Research.
https://www.ncbi.nlm.nih.gov/pubmed/9016151

Guo, Z-f., Lui, Y., Hu, G-h., Liu, H., & Xu, Y-f. (2014). Transcutaneous electrical nerve stimulation in the treatment of patients with poststroke urinary incontinence. Clinical Interventions in Aging, 9, 851-6.
https://www.ncbi.nlm.nih.gov/pubmed/24904204

Liu, Y., Xu, G., Luo, M., & Teng, H-f. (2016). Effects of transcutaneous electrical nerve stimulation at two frequencies on urinary incontinence in poststroke patients: a randomized controlled trial. American Journal of Physical Medicine and Rehabilitation, 95, 183-93.
https://www.ncbi.nlm.nih.gov/pubmed/26259053

Shin, D.C., Shin, S.H., Lee, M.M., Lee, K.J., & Song, C.H. (2016). Pelvic floor muscle training for urinary incontinence in female stroke patients: a randomized, controlled and blinded trial. Clinical Rehabilitation, 30(3), 259-67.
https://www.ncbi.nlm.nih.gov/pubmed/25862769

Tibaek, S., Gard, G., & Jensen, R. (2005). Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomized, controlled and blinded study. Neurourology and Urodynamics, 24, 348-57.
https://www.ncbi.nlm.nih.gov/pubmed/15791633

Tibaek S., Jensen R., Lindskov G., & Jensen, M. (2004). Can quality of life be improved by pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A randomised, controlled and blinded study. International Urogynecology Journal and Pelvic Floor Dysfunction, 15(2), 117-123.
http://www.ncbi.nlm.nih.gov/pubmed/15014939

Tibaek, S., Gard, G., & Jensen, R. (2007). Is there a long-lasting effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A 6-month follow-up study. International Urogynecology Journal, 18, 281-7.
https://www.ncbi.nlm.nih.gov/pubmed/16673051

Thomas, L.H., Watkins, C.L., Sutton, C.J., Forshaw, D., Leathley, M.J., French, B., Burton, C.R>, Cheater, F., Roe, B., Britt, D., Booth, J., McColl, E., ICONS Project Team, ICONS Patient/Public/Carer Involvement Groups. (2104). Identifying continence options after stroke (ICONS): a cluster randomized controlled feasibility trial. Trials, 509, 1-15.
https://www.ncbi.nlm.nih.gov/pubmed/25539714

Wikander B., Ekelund P., & Milsom, I. (1998). An evaluation of multidisciplinary intervention governed by functional independence measure (FIMSM) in incontinent stroke patients. Scandinavian Journal of Rehabilitation Medicine, 30(1), 15-21.
http://www.ncbi.nlm.nih.gov/pubmed/9526750

 


Excluded Studies:

Chesworth, B., Leathley, M., Thomas, L., Forshaw, D., Sutton, C., French, B., et al. (2013). Assessing fidelity to complex interventions: The ICONS experience. Trials, 14(1), 4.  
Reason for Exclusion: no health-related outcomes studied.

Chesworth, B., Leathley, M., Thomas, L., Sutton, C., Forshaw, D., Watkins, C.L., et al. (2015). Assessing fidelity to treatment delivery in the ICONS (Identifying Continence OptioNs after Stroke) cluster randomised feasibility trial. BMC Medical Research Methodology 15, 68.
Reason for Exclusion: no health-related outcomes studied.

Engberg, S., Sereika, S. M., McDowell, B. J., Weber, E., & Brodak, I. (2002). Effectiveness of prompted voiding in treating urinary incontinence in cognitively impaired homebound older adults. Journal of Wound Ostomy & Continence Nursing, 29(5), 252-265.
Reason for Exclusion: patients with stroke represent less than 50% of the sample.

Forshaw, D., Thomas, L.H., Watkins, C.L., French, B., Sutton, C., Cheater, F., et al. (2012). ICONS: Identifying continence options after stroke. International Journal of Stroke, 7(1), 45A.
Reason for Exclusion: not RCT, conference abstract.

French, B., Booth, J., Brittain, K., Burton, C., Cheater, F., Leathley, M., et al (2009). Preparing an intervention for incontinence after stroke: what might work? International Journal of Stroke, 4(2), A36-A37.
Reason for Exclusion: conference abstract.

Gong, J. & Gong, W. (2013). Bladder function training combined with water-drinking plan in the treatment of post-stroke patients with urinary incontinence. Modern Clinical Nursing, 12(4), 49-52.
Reason for Exclusion: unable to obtain English version of the full-text.

McDowell, B. J., Engberg, S., Sereika, S., Donovan, N., Jubeck, M. E., Weber, E., & Engberg, R. (1999). Effectiveness of behavioral therapy to treat incontinence in homebound older adults. Journal of the American Geriatrics Society, 47(3), 309-318.
Reason for Exclusion: patients with stroke represent less than 50% of the sample.

Smilskalne, B., Berzina, G., Gormalova, J., & Vetra, A. (2009). Post-stroke urinary incontinence. Effectiveness of management. International Journal of Rehabilitation Research, 32(1), S111.
Reason for Exclusion: conference abstract.

Sutton, C.J., Thomas, L., Forshaw, D., Watkins, C.L. (2011). Practical and methodological challenges in the design and implementation of a cluster-randomised feasibility trial of the management of urinary incontinence after stroke. Trials, 12(1), A151.
Reason for Exclusion: not a treatment RCT. 

Sutton, C.J., Watkins, C.L., Thomas, L.H., French, B., Forshaw, D., Bullock, M. (2012). Comparison of recruitment rates and participant characteristics: an assessment of potential selection bias in the ICONS (Identifying Continence OptioNs after Stroke) cluster-randomised trial (Abstract number 110). International Journal of Stroke 7(s2), 49.
Reason for Exclusion: no health-related outcomes studied.

Thomas, L., Barrett, J., Booth, J., Brittain, K., Burton, C., Carter, B. (2009). ICONS: Identifying Continence OptioNs after stroke. 4th UK Stroke Forum.
Reason for Exclusion: conference abstract.

Thomas, L.H., Watkins, C.L., French, B., Sutton, C., Forshaw, D., Cheater, F., et al. (2012). ICONS: Identifying Continence Options after Stroke: Preliminary findings from a randomised trial. International Journal of Stroke, 7(2), 6-7.
Reason for Exclusion: abstract.