Prevalence and predictors of health care use in patients with early hip or knee osteoarthritis: two-year follow-up data from the CHECK cohort.

OBJECTIVE: To describe health care utilization (HCU) and predict analgesic use and health professional (HP) contact at baseline and 2 years in individuals with early symptomatic hip and/or knee osteoarthritis (OA). DESIGN: Baseline and two-year data on HCU of the 1002 participants from the multi-centre Cohort Hip & Cohort Knee study were used. Six forms of health care services were described: analgesic use, supplement use, contact with a General Practitioner (GP), contact with a HP, contact in secondary care, and alternative medicine use. Multivariable logistic regression was performed in order to identify predisposing, enabling and disease-related variables that predict analgesic use and HP contact at 2 years; treatment modalities of first choice in early OA. RESULTS: For the hip (n=170), the knee (n=414) and the hip and knee (n=418) group analgesic use (38%, 29% and 47%, respectively), contact with a GP (32%, 38% and 36%, respectively) and contact with a HP (26%, 18% and 20%, respectively), were reported most often at baseline. Contact with a GP significantly decreased, supplement use increased (to about one third), and other treatment modalities remained stable at 2 years. In all three groups, analgesic use at baseline was the strongest predictor for analgesic use at 2 years, whereas contact with a HP at baseline was the strongest predictor of contact with a HP after 2 years. Belonging to a first generation minority was a predisposing risk factor [Odds Ratio (95%-CI), 8.72 (1.55-48.97)] for analgesic use in the hip and knee group. CONCLUSIONS: In early OA, familiarity with HCU and other predisposing factors are, apart from disease-related factors strongly associated with HCU at 2 years. Further research is necessary to examine whether our findings reflect sub-optimal management of early OA in terms of efficacy and equity.

[Fewer lung complications following inspiratory muscle training in patients undergoing coronary bypass surgery: a randomized trial]. / Minder longcomplicaties door ademspiertraining bij patiënten die een coronaire bypassoperatie moeten ondergaan: een gerandomiseerde trial.

OBJECTIVE: The aim of this study was to evaluate the prophylactic efficacy of preoperative physiotherapy, including inspiratory muscle training (IMT), on the incidence of postoperative pulmonary complications (PPCs) in high-risk patients scheduled for elective coronary artery bypass grafting (CABG). DESIGN: Randomized controlled clinical trial (www.controlled-trials. com/isrctn17691887). METHOD: Of 655 patients referred to a university medical centre in The Netherlands for elective CABG, 299 met the criteria for being at high risk of developing PPCs. A total of 279 were enrolled and monitored up to discharge from hospital. Patients were randomly assigned to receive either preoperative IMT (n=140) or usual care (n=139). Both groups received the same postoperative treatment. RESULTS: Both groups were comparable at baseline. Before CABG, 2 control group patients and 1 IMT group patient died. After CABG surgery, PPCs were present in 25 (18%) of 139 patients in the IMT group and 48 (35%) of 137 patients in the control group (OR: 0.52; 95% CI: 0.30-0.92). Pneumonia occurred in 9 (6.5%) of 139 patients in the IMT group and in 22 (16.1%) of 137 patients in the usual care group (OR: 0.40; 95% CI: 0.19-0.84). Mean duration of postoperative hospitalization was 7 (range 5-41) days in the IMT group versus 8 (range 6-70) days in the usual care group (Mann-Whitney test; Z: -2.42; p = 0.015). CONCLUSION: Preoperative physiotherapy, including IMT, statistically significantly reduced the incidence ofPPCs and the duration ofpostoperative hospitalization in patients at high risk of developing a pulmonary complication on undergoing CABG.

Balneotherapy for osteoarthritis.

BACKGROUND: Balneotherapy (or spa therapy, mineral baths) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain and as a consequence to relieve patients' suffering and make them feel well. In this update we included one extra study. OBJECTIVES: To assess the effectiveness of balneotherapy for patients with osteoarthritis (OA). SEARCH STRATEGY: We searched the following databases up to October 2006: EMBASE, PubMed, the Cochrane 'Rehabilitation and Related Therapies' Field database, PEDro, CENTRAL (Issue 3, 2006) and performed reference checking and communicated with authors to retrieve eligible studies. SELECTION CRITERIA: Randomised controlled trials (RCT) comparing balneotherapy with any intervention or no intervention. At least 90% of the patient population had to be diagnosed with OA. DATA COLLECTION AND ANALYSIS: Two authors independently assessed quality and extracted data. Disagreements were solved by consensus. In the event of clinical heterogeneity or lack of data we refrained from statistical pooling. MAIN RESULTS: Seven trials (498 patients) were included in this review. Two studies compared spa-treatment with no treatment. One study evaluated baths as an add-on treatment to home exercises and another compared thermal water from Cserkeszölö with tap water (placebo). Three studies evaluated sulphur or Dead Sea baths with no treatment or mineral baths with tap water baths or no treatment. Only one of the trials performed an intention-to-treat analysis and two studies provided data to perform an intention-to-treat analysis ourselves. A 'quality of life' outcome was reported by one trial. We found: silver level evidence concerning the beneficial effects on pain, quality of life and analgesic intake of mineral baths compared to no treatment (SMD between 1.82 and 0.34). a statistically significant difference in pain and function of Dead Sea + sulphur versus no treatment, only at end of treatment (WMD 5.7, 95%CI 3.3 to 8.1), but not at 3 month follow-up (WMD 2.6, 95%CI -1.1 to 6.3). no statistically significant differences in pain or function at one or three months of Dead Sea baths versus no treatment (WMD 0.5, 95%CI -0.6 to 1.6) or at one or three months of sulphur baths versus no treatment (WMD 0.4, 95%CI -0.9 to 1.7). Adverse events were not measured in the included trials. AUTHORS' CONCLUSIONS: We found silver level evidence (www.cochranemsk.org) concerning the beneficial effects of mineral baths compared to no treatment. Of all other balneological treatments no clear effects were found. However, the scientific evidence is weak because of the poor methodological quality and the absence of an adequate statistical analysis and data presentation. Therefore, the noted "positive findings" should be viewed with caution.

Conservative treatments for whiplash.

BACKGROUND: Many treatments are available for whiplash patients but there is little scientific evidence for their accepted use. Patients with whiplash-associated disorders (WAD) can be classified by the severity of signs and symptoms from Grade 0 (no complaints or physical signs) to Grade 4 (fracture or dislocation). OBJECTIVES: To assess the effectiveness of conservative treatment for patients with whiplash injuries rated as Grades 1 or 2 (neck and musculoskeletal complaints). SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2006, Issue 3), MEDLINE, CINAHL, PsycINFO, and PEDro to November 2006 and screened references of identified randomised trials and relevant systematic reviews. SELECTION CRITERIA: We selected randomised controlled trials published in English, French, German or Dutch, that included patients with a whiplash-injury, conservative interventions, outcomes of pain, global perceived effect or participation in daily activities. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the methodological quality using the Delphi criteria and extracted the data onto standardised data-extraction forms. We did not pool the results because of the heterogeneity of the population, intervention and outcomes and lack of data. A pre-planned stratified analysis was performed for three different comparisons. MAIN RESULTS: Twenty-three studies (2344 participants) were included in this update, including nine new studies. A broad variety of conservative interventions were evaluated. Two studies included patients with chronic symptoms (longer than three months), two included subacute (four to six weeks) symptoms, two had undefined duration of symptoms, and 17 studied patients with acute (less than three weeks) symptoms. Only eight studies (33.3%) satisfied one of our criteria of high quality, indicating overall, a poor methodological quality. Interventions were divided into passive (such as rest, immobilisation, ultrasound, etc) and active interventions (such as exercises, act as usual approach, etc.) and were compared with no treatment, a placebo or each other. Clinical and statistical heterogeneity and lack of data precluded pooling. Individual studies demonstrated effectiveness of one treatment over another, but the comparisons were varied and results inconsistent. Therefore, the evidence neither supports nor refutes the effectiveness of either passive or active treatments to relieve the symptoms of WAD, Grades 1 or 2. AUTHORS' CONCLUSIONS: The current literature is of poor methodological quality and is insufficiently homogeneous to allow the pooling of results. Therefore, clearly effective treatments are not supported at this time for the treatment of acute, subacute or chronic symptoms of whiplash-associated disorders.

Long term results of neuromodulation by sacral nerve stimulation for lower urinary tract symptoms: a retrospective single center study.

OBJECTIVE: To analyse the influence of technical improvements of Sacral Nerve Stimulation (SNS) on the incidence of surgical interventions and subjective long-term results of SNS. METHODS: Retrospective, transversal study analyzing records of implanted patients at our department of Urology. RESULTS: Of 149 patients analyzed, 107 had overactive bladder symptoms and 42 had urinary retention. Mean follow-up was 64,2 (sd = 38,5) months. In the whole group 194 adverse events occurred. 6 Patients had infection in their implanted system, one was explanted for infection. Most events could be solved by giving advice or by reprogramming the stimulator. 129 reoperations have been performed and 21 patients had their system explanted. Analysis of the data shows a striking difference in the incidence of reoperations, but small differences in subjective results in the groups of patients implanted before or after 1996, suggesting that a proactive approach towards adverse events is worthwhile. CONCLUSIONS: SNS gives lasting benefit in patients with refractory symptoms of overactive bladder and non-obstructive urinary retention. The differences in outcomes and incidence of reoperation can be attributed to the learning curve and technical and surgical improvements in the application of SNS.

European experience with bilateral sacral neuromodulation in patients with chronic lower urinary tract dysfunction.

Although there is experimental and clinical evidence that bilateral stimulation of the sacral nerves could lead to summation effects, no significant differences in unilateral versus bilateral neuromodulation could be demonstrated in a comparative trial. In some individuals, however, only bilateral stimulation relieved symptoms. Therefore, if a unilateral percutaneous nerve evaluation test fails, a bilateral test should be considered. Further clinical research with long-term follow-up will allow the identification of which patients could benefit from bilateral stimulation with greater specificity and ameliorate further the long-term results achieved with unilateral SNS.

Balneotherapy for rheumatoid arthritis.

BACKGROUND: Balneotherapy (spa therapy) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain, improve joint motion and as a consequence to relieve people' suffering and make them feel well. OBJECTIVES: To perform a systematic review on the effectiveness of balneotherapy for rheumatoid arthritis. SEARCH STRATEGY: Using the Cochrane search strategy, studies were found by screening: 1) The MEDLINE CD-ROM database from 1966 to June 2002 and 2) the database from the Cochrane 'Rehabilitation and Related Therapies' Field, the Pedro database up to June 2002. Also, 3) reference checking and 4) personal communications with authors was carried out to retrieve eligible studies. Date of the most recent literature search: June, 2002 SELECTION CRITERIA: Studies were eligible if they were randomised controlled trials (RCTs) comparing balneotherapy with any other intervention or with no intervention. Included participants all suffered from definite or classical rheumatoid arthritis (RA) as defined by the American Rheumatism Association Criteria (ARA) or by the criteria of Steinbrocker. At least one of the WHO/ILAR core set of endpoints for RA clinical trials had to be among the main outcome measures. DATA COLLECTION AND ANALYSIS: The Delphi list was the criteria list used to assess the components of methodological quality. Two reviewers carried out quality assessment and data extraction of the studies. Disagreements were solved by consensus. MAIN RESULTS: Six trials, representing 355 people, were included in this review. Most trials reported positive findings (the absolute improvement in measured outcomes ranged from 0 to 44%), but were methodologically flawed to some extent. A 'quality of life' outcome was reported by two trials. None of the trials performed an intention-to-treat analysis and only two performed a comparison of effects between groups. Pooling of the data was not performed; because of heterogeneity of the studies, multiple outcome measurements, and the overall data presentation was too scarce. REVIEWER'S CONCLUSIONS: One cannot ignore the positive findings reported in most trials. However the scientific evidence is insufficient because of the poor methodological quality, the absence of an adequate statistical analysis, and the absence, for the patient, of most essential outcome measures (pain, self assessed function, quality of life). Therefore, the noted "positive findings" should be viewed with caution. Because of the methodological flaws an answer about the apparent effectiveness of balneotherapy cannot be provided at this moment. A large, methodological sound trial is needed.

Predictive factors for sacral neuromodulation in chronic lower urinary tract dysfunction.

OBJECTIVES: To investigate data from 211 patients who underwent a trial stimulation (percutaneous nerve evaluation [PNE]) to determine the clinical parameters that can enhance the prediction of PNE success. The advantageous effect of sacral neuromodulation depends on the accurate identification of suitable candidates during the preimplantation PNE. METHODS: A total of 211 patients (161 women and 50 men), with refractory urge incontinence, urgency-frequency syndrome, and urinary retention, underwent a PNE. Patient data (demographics, medical history, urologic investigations, and diagnosis) were collected. The PNE results were evaluated from a voiding diary and patient history. More than 50% improvement of voiding parameters was considered a successful PNE, and those patients were selected for implantation. Logistic regression analysis was performed. The factors tested for predicting the test result were sex, patient age, diagnosis, previous surgery, neurogenic bladder dysfunction, duration of complaints, and previous treatments. RESULTS: The PNEs were positive in 85 patients (40.3%) and negative in 105 patients (49.8%). In 18 patients (8.5%), the test electrode had migrated; 3 more patients were not assessable and were also excluded. Missing data on the variable "duration of complaints" reduced the number of patients in the analyses from 190 to 174 patients. CONCLUSIONS: Intervertebral disk prolapse, duration of complaints, neurogenic bladder dysfunction, and urge incontinence were found to be significant predictive factors. However, a PNE remains necessary to evaluate a patient's chance of implant success objectively.

Unilateral versus bilateral sacral neuromodulation in patients with chronic voiding dysfunction.

PURPOSE: Bilateral sacral nerve neuromodulation has been proposed as a more effective treatment for chronic voiding dysfunction. However no comparison with the unilateral approach has been performed. We investigated the possible advantage of bilateral sacral neuromodulation. MATERIALS AND METHODS: In a prospective randomized crossover trial we investigated 33 patients who underwent bilateral implantation of a temporary test lead. Unilateral and bilateral test stimulation was continued for 4 to 6 days in all patients. Patients were randomly assigned to start with bilateral or unilateral stimulation. Between the stimulation episodes a 2-day washout interval was scheduled. Voiding diaries were completed at baseline and during the entire stimulation period. Sacral x-rays were taken to confirm lead positioning or possible migration after implantation and at the end of the test stimulation period. After 10 days the temporary leads were removed and voiding diaries were analyzed. RESULTS: After stimulation sacral x-ray revealed test lead migration in 8 patients, leaving 12 patients with urge incontinence and 13 with voiding difficulty and urinary retention available for review. A statistically significant improvement in voiding parameters was seen during the test stimulation period. However no statistically significant improvement was seen due to bilateral stimulation compared to unilateral stimulation. Two patients with urinary retention only started voiding to completion during bilateral stimulation. CONCLUSIONS: Bilateral is in general not superior to unilateral sacral neuromodulation. However, in some individuals bilateral stimulation may be more effective in relieving symptoms. Therefore, if unilateral percutaneous nerve evaluation fails, a bilateral test should be considered.

Balneotherapy for rheumatoid arthritis and osteoarthritis.

BACKGROUND: Balneotherapy (hydrotherapy or spa therapy) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain and as a consequence to relieve patients' suffering and make them feel well. OBJECTIVES: To perform a systematic review to assess the effects of balneotherapy for rheumatoid arthritis and osteoarthritis. SEARCH STRATEGY: Using the Cochrane search strategy, studies were found by screening: 1) The Medline CD-ROM database from 1966 to June 1999 and 2) the database from the Cochrane Field 'Rehabilitation and Related Therapies', which contains also studies published in journals not covered by Medline. Also, 3) reference checking and 4) personal communications with authors was carried out to retrieve eligible studies. To perform an adequate assessment of the methodological quality the languages of the publications had to be: Dutch, English, French or German. Date of the most recent literature search: June, 1999 SELECTION CRITERIA: Studies were eligible if they were randomized controlled trials (RCT) comparing balneotherapy with any intervention or with no intervention. Patients included had rheumatoid arthritis (RA), osteoarthritis (OA) or some other form of arthritis. Trials incorporating patients with definite or classical rheumatoid arthritis (RA) as defined by the American Rheumatism Association Criteria (ARA) (Ropes 1958) (these criteria have changed over time) or by the criteria of Steinbrocker (1949) were regarded as a separate group. At least one of the WHO/ILAR core set of endpoints for RA clinical trials had to be the main outcome measures. DATA COLLECTION AND ANALYSIS: A criteria list used to assess the methodological quality was the one developed at the Department of Epidemiology at the Maastricht University, called "the Maastricht list". The quality scores and data abstraction of the studies were carried out independently by two reviewers (HdV, RdB). Disagreements were solved by consensus. MAIN RESULTS: Ten trials with 607 patients were included in this review. Most trials reported positive findings, but were methodologically flawed to some extent. A 'quality of life' outcome was reported by two trials. Just one of the randomized trials mentioned an intention-to-treat analysis and only three performed a comparison of effects between groups. Pooling of the data was not performed, because of heterogeneity of the studies, multiple outcome measurements, and, apart from two studies, the overall data presentation was too scarce to enable pooling of the data. REVIEWER'S CONCLUSIONS: One cannot ignore the positive findings reported in most trials. However the scientific evidence is weak because of the poor methodological quality, the absence of an adequate statistical analysis, and the absence, for the patient, of most essential outcome measures (pain, quality of life), Therefore, the noted "positive findings" should be viewed with caution. Because of the methodological flaws an answer about the efficacy of balneotherapy cannot be provided at this time. Flaws found in the reviewed studies could be avoided in future trials.

Conservative treatment of urge urinary incontinence in women: a systematic review of randomized clinical trials.

OBJECTIVE: To assess the efficacy of physical therapies for first-line use in the treatment of urge urinary incontinence (UUI) in women, using a systematic review of randomized clinical trials (RCTs). MATERIALS AND METHODS: A computer-aided and manual search was carried out for RCTs published between 1980 and 1999 investigating the treatment of UUI defined by the keywords 'physical therapies', e.g. bladder (re)training (including 'behavioural' treatment), pelvic floor muscle (PFM) exercises, with or without biofeedback and/or electrical stimulation. The methodological quality of the included trials was assessed using methodological criteria, based on generally accepted principles of interventional research. RESULTS: Fifteen RCTs were identified; the methodological quality of the studies was moderate, with a median (range) score of 6 (3-8.5) (maximum possible 10). Eight RCTs were considered of sufficient quality, i.e. an internal validity score of >/= 5.5 points on a scale of 0-10, and were included in a further analysis. Based on levels-of-evidence criteria, there is weak evidence to suggest that bladder (re)training is more effective than no treatment (controls), and that bladder (re)training is better than drug therapy. Stimulation types and parameters in the studies of electrical stimulation were heterogeneous. There is insufficient evidence that electrical stimulation is more effective than sham electrical simulation. To date there are too few studies to evaluate effects of PFM exercise with or without biofeedback, and of toilet training for women with UUI. CONCLUSION: Although almost all studies included reported positive results in favour of physical therapies for the treatment of UUI, more research of high methodological quality is required to evaluate the effects of each method in the range of physical therapies.

Conservative treatment of stress urinary incontinence in women: a systematic review of randomized clinical trials.

OBJECTIVE: To assess the efficacy of physical therapies for first-line use in the treatment and prevention of stress urinary incontinence (SUI) in women, using a systematic review of randomized clinical trials (RCTs). MATERIALS AND METHODS: A computer-aided and manual search for published RCTs investigating treatment and prevention of SUI using physical therapies, e.g. pelvic floor muscle (PFM) exercises, with or without other treatment modalities, were carried out. The methodological quality of the included trials was assessed using criteria based on generally accepted principles of interventional research. RESULTS: Twenty-four RCTs (22 treatment and two prevention) were identified; the methodological quality of the studies included was moderate and 11 RCTs were of sufficient quality to be included in further analysis. Based on levels-of-evidence criteria, there is strong evidence to suggest that PFM exercises are effective in reducing the symptoms of SUI. There is limited evidence for the efficacy of high-intensity vs a low-intensity regimen of PFM exercises. Despite significant effects of biofeedback after testing as an adjunct to PFM exercises, there is no evidence that PFM exercises with biofeedback are more effective than PFM exercises alone. There is little consistency (of stimulation types and parameters) in the studies of electrical stimulation, but when the results are combined there is strong evidence to suggest that electrostimulation is superior to sham electrostimulation, and limited evidence that there is no difference between electrostimulation and other physical therapies. In the prevention of SUI the efficacy of PFM exercises, with or without other adjuncts, is uncertain.

Balneotherapy and quality assessment: interobserver reliability of the Maastricht criteria list and the need for blinded quality assessment.

This study investigates aspects of the reliability of the Maastricht criteria list for quality assessment in systematic reviews, and whether blinded reviewing is necessary to prevent review bias. We used the data set of 12 articles from a systematic review concerning the efficacy of balneotherapy in patients with arthritis. Twenty reviewers participated of which two reviewers, who have been involved in developing the Maastricht criteria list, acted as reference standard. Half of all assessments were performed blindly. A high level of agreement was found between the reviewers and a high level of correlation with the reference standard. The quality scores between the blinded and unblinded assessment did not differ much. Based on the results we conclude that the Maastricht criteria list is a reliable instrument in quality assessment of clinical trials. Within the limits of this study we found no evidence that blinding is necessary to prevent review bias.

Taking baths: the efficacy of balneotherapy in patients with arthritis. A systematic review.

OBJECTIVE: To review English, French, German, and Dutch language studies of the effectiveness of balneotherapy. Balneotherapy (hydrotherapy or spa therapy) is one of the oldest forms of therapy for patients with arthritis. One of the aims of balneotherapy is to relieve pain. METHODS: We performed a systematic review that included randomized and nonrandomized studies. Quality scores of the studies were determined using a criteria list. RESULTS: Most studies report positive findings, but all studies showed methodological flaws. A quality of life measurement was never reported as an outcome measure. None of the randomized clinical trials included intention-to-treat analysis or comparison of effects between groups. CONCLUSION: Because of the methodological flaws a conclusion about the efficacy of balneotherapy cannot be provided from studies we reviewed. We conclude that most flaws found could be avoidable in future research.

Whiplash: assessing the validity of diagnostic tests in a cervical sensory disturbance.

OBJECTIVE: To determine the ability of two diagnostic tests that examine sensory disturbance in whiplash patients to discriminate between 'extreme' groups. BACKGROUND: The neuromuscular theories have been accepted as explanations of the symptoms after a whiplash injury. Dutch manual therapists often use the diagnostic tests under study to diagnose and treat sensory disturbances after such an injury. The validity of a test needs to be assessed before its efficacy as a treatment in whiplash patients can be tested. The aim of this study was to validate two diagnostic tests and to initiate further research on the efficacy of a treatment of a sensory disturbance in whiplash patients. METHOD: Twelve subjects with chronic symptoms (> 3 months) after a whiplash injury (patient group) and 18 subjects without any head or neck problems (control group) were studied. The tests under study were the extension test and the coordination test. All researchers were blind to the characteristics of the subjects. RESULTS: The extension test and the coordination test were able to discriminate adequately between subjects with symptoms after a whiplash injury (patients) and subjects without any head or neck complaints (control subjects). Patients clearly show a smaller degree of extension compared with the control subjects and an increase of extension movement with external fixation. The sensitivity as well as the specificity of the coordination test were good (both > .80). CONCLUSION: These diagnostic tests seemed to be valid instruments for discriminating between whiplash patients with symptoms and healthy people.

Efficacy of biofeedback, when included with pelvic floor muscle exercise treatment, for genuine stress incontinence.

UNLABELLED: We performed a randomized clinical trial on the efficacy of physical therapy on genuine stress incontinence. STUDY OBJECTIVE: "Is a physical therapeutical training program (pelvic floor muscle training) combined with biofeedback, more effective than the same program without biofeedback in patients with mild or moderate stress incontinence?" Forty-four patients were referred by a general practitioner or a urologist. After informed consent, 40 patients were randomized in an exercises and biofeedback group (BF), or treated with exercises exclusively (pelvic floor muscle training = PFMT). After a diagnostic phase of 1 week every patient received twelve treatment sessions, three times weekly. The primary measure of effect, the quantity of involuntary urine loss, was measured with the 48 hours PAD test (Inco-test Mölnlycke). Before every treatment session the Symptoms questionnaire was filed out by the patient and the Patient dairy was controlled. The data of the trial were analysed according to the principal of intention to treat. During the trial there was 100% compliance. There were no drop-outs. Both treatment modalities appeared to be effective. After twelve treatment sessions there was a mean improvement of +/- 55% (P = 0.00) in both treatment groups, measured by the primary measure of effect. In the group with BF this improvement was already realized after six treatment sessions (P = 0.01). Yet, the difference between BF and PFMT faded to reach significance at six treatment sessions (P = 0.08). Although differences in treatment effects between both groups were not significant, our findings suggest that adding biofeedback to pelvic floor muscle exercises might be more effective than pelvic floor muscle exercises alone after six treatments.