Translation and validation of the international consultation on incontinence questionnaire-Bowel in Danish men and women with pelvic floor disorders.

BACKGROUND: We lack a comprehensive validated Danish questionnaire to evaluate symptoms and bother regarding anal incontinence (AI). The International Consultation on Incontinence Questionnaire-Bowel (ICIQ-B) is an internationally recommended questionnaire containing 21 items, of which 17 are scored in three subscales: bowel pattern, bowel control, and quality of life. AIMS: To translate the ICIQ-B into Danish and to validate the Danish version in pelvic floor disorder (PFD) patients with and without AI. METHODS: The ICIQ-B was translated by a panel of healthcare professionals followed by cognitive interviews with PFD patients attending an outpatient clinic. Revisions were undertaken using an iterative process, and a backward translation was performed for the final version. Pretesting and test-retest of the ICIQ-B were done online and administrated together with the St. Mark's score. Content, structural, convergent and discriminant validity were assessed, followed by an evaluation of relative and absolute reliability, including the smallest real difference (SRD). RESULTS: Thirty cognitive patient interviews were performed, resulting in three revisions. The Danish ICIQ-B was found to be comprehensible and relevant but lacked items addressing the psychological impact of bowel problems. The ICIQ-B was completed online by 227 PFD patients with and without AI. The structural validity of the bowel pattern subscale could not be retrieved. Patients indicating AI had significantly higher ICIQ-B and St. Mark's scores than patients without AI, and ICIQ-B subscale scores correlated moderately with St. Mark's scores. Internal consistency was good except for the bowel pattern subscale. Seventy-six patients completed test-retest. Relative reliability was excellent for subscale scores and moderate or good for single items except for the item concerning stool consistency, which was weak. The SRD was found to be 2.8 for the bowel pattern subscale, 4.3 for bowel control subscale, and 3.6 for the quality-of-life subscale. CONCLUSION: The Danish version of the ICIQ-B can be used for Danish patients with PFD, and discriminant validity is good. The structural validity and the internal consistency of the bowel pattern subscale are questionable, indicating that some items do not represent the underlying construct. Test-retest reliability of the ICIQ-B is acceptable, but the change needed to reflect a real change above the measurement error in each subscale is three to four points.

Treatment of postgestational rectus diastasis.

Rectus diastasis is defined by thinning and widening of linea alba and is a part of pregnancy. In some patients, the diastasis persists giving symptoms such as core instability, and cosmetic complaints. Treatment consists of exercise and surgery by either a plastic surgeon or a general surgeon. Lately, rectus diastasis has gained both national and international attention but it is not clear which patients will benefit from surgery or which operative technique has the best outcome. This review describes postgestational rectus diastasis and summarizes treatment possibilities based on the latest literature.

Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners: Results From the Randomized ProCan Trial.

INTRODUCTION: Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function. AIM: To compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP. METHODS: The ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months' follow-up. Linear mixed-effect models and 95% confidence intervals were used to measure effects of the intervention. MAIN OUTCOME MEASURE: Primary outcome was erectile function, measured with The International Index of Erectile Function, at 8 and 12 months follow-up. Secondary outcomes were sexual and urinary function and use of treatment for erectile dysfunction (ED) by patients; sexual function in female partners; and relationship function, health-related quality of life, anxiety, depression, and self-efficacy in both patients and female partners. RESULTS: Thirty-five couples were randomized. No significant effect of the intervention was found on erectile function at 8 months (estimated difference in change, 1.41; 95% CI; -5.51 ; 8.33) or 12 months (estimated difference in change, 0.53; 95% CI; -5.94; 6.99) or in secondary outcomes, except for significantly increased use of ED treatment at 8 months. CONCLUSION: We found no effect of early couple counseling and PFMT, possibly because of the limited number of participants. Karlsen RV, Bidstrup PE, Giraldi A, et al. Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners. Results From the Randomized ProCan Trial. Sex Med 2021;9:100350.

Pelvic floor muscle training with and without supplementary KAATSU for women with stress urinary incontinence - a randomized controlled pilot study.

AIMS: To explore if adding occlusion training of a thigh (KAATSU) to low-intensity pelvic floor muscle training (PFMT) could increase effect of PFMT in women with stress urinary incontinence (SUI). METHODS: Single-blinded randomized controlled pilot study. Women with SUI and an ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Short form) score of ≥12 were randomized to a low-intensity PFMT program followed by KAATSU (KAATSU + PFMT) or to a low-intensity PFMT program without KAATSU (PFMT group), both performed four times a week for 12 weeks. PRIMARY OUTCOME: Change in the ICIQ-UI-SF score at a 12-week follow-up. SECONDARY OUTCOMES: a 3-day leakage diary, the PGI-I (Patient Global Index of Improvement scale), bother with KAATSU in a numeric rank scale and change in urethral opening pressure (UOP) measured with urethral pressure reflectometry (UPR) at rest, contraction and straining at the 12-week follow-up. RESULTS: Forty-one women with SUI and an ICIQ-UI-SF of 13 (range 12-16) were included. Fourteen in the KAATSU + PFMT and 17 in the PFMT group completed the study. Both groups had a significant and clinically relevant improvement of the ICIQ-UI-SF score and decrease in number of incontinence episodes with no significant between group differences. UOP did not increase significantly in either group. Bother with KAATSU was low but seven of 14 women expressed dislike with KAATSU. CONCLUSIONS: The added KAATSU protocol did not increase the effect of low-intensity PFMT and it was not well tolerated. While subjective effect was significant in both intervention groups this was not reflected in the UPR measures.

Efficacy of Supervised Pelvic Floor Muscle Training and Biofeedback vs Attention-Control Treatment in Adults With Fecal Incontinence.

BACKGROUND & AIMS: Pelvic floor muscle training (PFMT) in combination with conservative treatment is recommended as first-line treatment for patients with fecal incontinence, although its efficacy is unclear. We investigated whether supervised PFMT in combination with conservative treatment is superior to attention-control massage treatment and conservative treatment in adults with fecal incontinence. METHODS: We performed a randomized, controlled, superiority trial of patients with fecal incontinence at a tertiary care center at a public hospital in Denmark. Ninety-eight adults with fecal incontinence were randomly assigned to groups that received supervised PFMT and biofeedback plus conservative treatment or attention-control treatment plus conservative treatment. The primary outcome was rating of symptom changes, after 16 weeks, based on scores from the Patient Global Impression of Improvement scale. Secondary outcomes were changes in the Vaizey incontinence score (Vaizey Score), Fecal Incontinence Severity Index, and Fecal Incontinence Quality of Life Scale. RESULTS: In the intention-to-treat analysis, participants in the PFMT group were significantly more likely to report improvement in incontinence symptoms based on Patient Global Impression of Improvement scale scores (unadjusted odds ratio, 5.16; 95% CI, 2.18-12.19; P = .0002). The PFMT group had a larger reduction in the mean Vaizey Score (reduction, -1.83 points; 95% CI, -3.57 to -0.08; P = .04). There were no significant differences in condition-specific quality of life. In the per-protocol analyses, the superiority of PFMT was increased. No adverse events were reported. CONCLUSIONS: This randomized controlled trial of adults with fecal incontinence provides support for a superior effect of supervised PFMT in combination with conservative treatment compared with attention-control massage treatment and conservative treatment. We found that participants who received supervised PFMT had 5-fold higher odds of reporting improvements in fecal incontinence symptoms and had a larger mean reduction of incontinence severity based on the Vaizey Score compared with attention control massage treatment. Clinicaltrials.gov no: NCT01705535.

The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an investigator-blinded parallel randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence is a prevalent problem in women with spinal cord injury. The aim of this study was to examine the effect of pelvic floor muscle training (PFMT) alone and combined with intravaginal electrical stimulation (IVES) on urinary incontinence in women with incomplete spinal cord injury. METHODS: In this investigator-blinded randomized clinical trial, we recruited women aged 18-75 with incomplete spinal cord injury and urinary incontinence from a single spinal cord injury clinic in Denmark. Women were randomly assigned to either PFMT or PFMT combined with IVES daily at home for 12 weeks. All women were trained by a physiotherapist using vaginal palpation and electromyography biofeedback. Outcome measures were recorded at baseline (week 0), post-intervention (week 12) and follow-up (week 24) and included change in the total score on the International Consultation on Incontinence Questionnaire urinary incontinence short form (ICIQ-UI-SF) and daily episodes of urinary incontinence. RESULTS: From 27 April 2015-9 September 2016, we randomly assigned 36 women (17 in the PFMT group and 19 in the PFMT+IVES group); 27 completed the interventions (13 in the PFMT group and 14 in the PFMT+IVES group). The results showed no difference between the groups on ICIQ-UI-SF or episodes of urinary incontinence at 12 and 24 weeks. Only the PFMT group had a significant change from baseline on ICIQ-UI-SF [-2.4 (95% CI -4.3--0.5), p = 0.018] and daily episodes of urinary incontinence [-0.4 (95% CI -0.8--0.1), p = 0.026] at 12 weeks. CONCLUSIONS: PFMT+IVES is not superior to PFMT alone in reducing urinary incontinence in women with incomplete spinal cord injury.

Feasibility and acceptability of couple counselling and pelvic floor muscle training after operation for prostate cancer.

BACKGROUND: Radical prostatectomy is often followed by long-lasting erectile dysfunction and urinary incontinence, with adverse effects on the quality of life and intimate relationship of patients and partners. We developed the ProCan intervention to ameliorate sexual and urological dysfunction after radical prostatectomy and examined its feasibility, acceptability and changes in sexual function. MATERIAL AND METHODS: Between May 2014 and October 2014, seven couples attending the Department of Urology, Rigshospitalet, were included 3-4 weeks after radical prostatectomy in the ProCan intervention, which consists of up to six couple counselling sessions, group instruction in pelvic floor muscle training (PFMT), up to three individual PFMT sessions and a DVD home training program. We examined its feasibility on the basis of the recruitment rate, adherence to and acceptability of the intervention, the response rate and changes in erectile and sexual functioning measured on the International Index of Erectile Function at baseline and at eight and 12 months. RESULTS: The recruitment rate was 14%. One couple withdrew, six couples attended 1-4 counselling sessions, and all patients attended PFMT until continence was achieved. The response rate on outcomes was 85% for patients and 71% for partners. The couples reported that counselling improved their sex life but it did not improve their ability to talk openly about sex. Most patients found that the physiotherapist improved their motivation and the quality and intensity of PFMT. Erectile dysfunction improved from severe at baseline to moderate at eight months' follow-up, and mean sexual functioning improved from 18.4 to 37.1 points at eight months' follow-up, but decreased slightly to 31.4 at 12 months. CONCLUSION: Our results suggest that the recruitment procedure should be adapted and minor revisions are needed in the intervention. The key components, couple counselling and PFMT, were well accepted and achievable for the patients.

Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial.

INTRODUCTION: Faecal incontinence affects approximately 8-9% of the adult population. The condition is surrounded by taboo; it can have a devastating impact on quality of life and lead to major limitations in daily life. Pelvic floor muscle training in combination with information and fibre supplements is recommended as first-line treatment for faecal incontinence. Despite this, the effect of pelvic floor muscle training for faecal incontinence is unclear. No previous trials have investigated the efficacy of supervised pelvic floor muscle training in combination with conservative treatment and compared this to an attention-control massage treatment including conservative treatment. The aim of this trial is to investigate if 16 weeks of supervised pelvic floor muscle training in combination with conservative treatment is superior to attention-control massage treatment and conservative treatment in patients with faecal incontinence. DESIGN: Randomised, controlled, superiority trial with two parallel arms. METHODS: 100 participants with faecal incontinence will be randomised to either (1) individually supervised pelvic floor muscle training and conservative treatment or (2) attention-control massage treatment and conservative treatment. The primary outcome is participants' rating of symptom changes after 16 weeks of treatment using the Patient Global Impression of Improvement Scale. Secondary outcomes are the Vaizey Incontinence Score, the Fecal Incontinence Severity Index, the Fecal Incontinence Quality of Life Scale, a 14-day bowel diary, anorectal manometry and rectal capacity measurements. Follow-up assessment at 36 months will be conducted. DISCUSSION: This paper describes and discusses the rationale, the methods and in particular the statistical analysis plan of this trial.

The 12-month effects of structured lifestyle advice and pelvic floor muscle training for pelvic organ prolapse.

INTRODUCTION: We evaluated the 12-month effects of adding pelvic floor muscle training to a lifestyle advice program in women with symptomatic pelvic organ prolapse stage II-III and the number of women who had sought further treatment. MATERIAL AND METHODS: This study was a 12-month follow up of a randomized controlled trial comparing a structured lifestyle advice program alone (lifestyle group) or in combination with pelvic floor muscle training (training and lifestyle group). Both programs consisted of six separate group sessions within 12 weeks. RESULTS: Data were available from 83 (76%) of the 109 originally included women. At the 12-month follow up, 34/83 (41%) had not sought further treatment, 13/43 (30%) in the lifestyle group and 21/40 (52%) in the training and lifestyle group, and these could be included for analysis. The lifestyle group had significantly improved bladder symptoms compared with baseline on single-item analysis (p = 0.01). The training and lifestyle group had significantly improved pelvic organ prolapse symptoms on single-item analysis (p = 0.02) and of bowel-related quality of life (p = 0.04). No significant between-group differences were found in the symptom and quality of life scores. All together 49 women (59%) had sought further treatment, 70% in the lifestyle group, and 48% in the training and lifestyle group (p = 0.05). Twenty-six in the lifestyle group, and 15 in the training and lifestyle group had sought conservative treatment. Four women in each group had received surgery. More severe anterior prolapse and more bladder symptoms at the 3-month follow up were significantly associated with having sought further treatment in both groups. CONCLUSIONS: At 12-month follow up, the effects of adding pelvic floor muscle training to a structured lifestyle advice program were limited.

Lifestyle advice with or without pelvic floor muscle training for pelvic organ prolapse: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: We evaluated the effect of adding pelvic floor muscle training (PFMT) to a structured lifestyle advice program. METHODS: This was a single-blinded randomized trial of women with symptomatic pelvic organ prolapse (POP) stage ≥ II. Participants were randomized to a structured lifestyle advice program with or without PFMT. Both groups received similar lifestyle advice in six separate group sessions. The combined group performed group PFMT after an individual assessment. Primary outcome was a global improvement scale at six-month follow-up. Secondary outcomes were the global scale and objective POP at three-month follow-up, symptoms and quality of life including sexuality, at three and six-month follow-up. A clinically relevant change of symptoms was defined as ≥ 15 %. RESULTS: We included 109 women. Eighty-nine women (82 %) completed three months follow-up; 85 (78 %) completed six-month follow-up. At both follow-ups, significantly more women in the combined group reported improvement in the global scale. At the three-month follow-up, the combined group only had significant improvement of POP symptoms while only the lifestyle advice group had significant improvement of quality of life. Change in objective POP and sexuality was nonsignificant. The symptom score improved 17 % in the combined group and 14 % in the lifestyle advice group (P = 0.57). Significantly more women in the lifestyle advice group had sought further treatment at the six-month follow-up. CONCLUSION: Adding PFMT to a structured lifestyle advice program gave superior results in a global scale and for POP symptoms. Overall effect of either intervention barely reached clinical relevance.

Validation of the Pelvic Floor Distress Inventory-20 and the Pelvic Floor Impact Questionnaire-7 in Danish women with pelvic organ prolapse.

OBJECTIVE: To translate the Pelvic Floor Distress Inventory-20 (PFDI-20) and the Pelvic Floor Impact Questionnaire-7 (PFIQ-7) and to evaluate their psychometric properties in Danish women with symptomatic pelvic organ prolapse. DESIGN AND SETTING: Cross-sectional, university hospital setting. SAMPLE: Women with symptomatic pelvic organ prolapse (n = 132). METHODS: A panel of gynecologists performed three independent translations, which were combined and psychometrically evaluated through interviews and pretesting. MAIN OUTCOME MEASURES: Construct, content and convergent validity. Internal consistency and reliability. Sensitivity to change, responsiveness and minimal clinical important difference. RESULTS: After two revisions PFDI-20 demonstrated good construct and content validity but PFIQ-7 showed major ceiling effect and lacked items describing affection of health-related quality of life. Convergent validity was moderate with only single items of PFDI-20 correlating with the pelvic organ prolapse quantification system (POP-Q) and only weak to moderate correlations between PFDI-20 and PFIQ-7 scores. Cronbach's alpha and inter-item-total correlation analysis were satisfactory overall. Intra-class correlation coefficient demonstrated good reliability for all but one subscale (r = 0.701-0.894 p < 0.001). Wilcoxon signed rank test showed significant sensitivity to change. Effect size and standardized response mean was good in pelvic organ prolapse subscales and correlated with the Patient Global Index of Improvement scale (PGI-I). Minimal clinical important difference could not be clearly demonstrated. CONCLUSION: The Danish version of PFDI-20 is valid while the PFIQ-7 has a major ceiling effect and lacks items about health-related quality of life. The subscales of PFDI-20 and PFIQ-7 demonstrate good internal consistency and reliability. Pelvic organ prolapse subscales show good responsiveness.

[Pelvic floor muscle training in pregnant and parturient women--a survey of a Cochrane review]. / Baekkenbundstraening til gravide og barslende kvinder--en gennemgang af et Cochrane-review.

Urinary and anal incontinence are prevalent in pregnant and parturient women. Pelvic floor muscle training is frequently employed for prevention and treatment. A recent Cochrane review is discussed. Fifteen studies with a total of 6,181 women were included. Pregnant women without urinary incontinence experienced a reduction of the risk of developing urinary incontinence in later pregnancy or post partum. Peripartum patients with urinary and anal incontinence experienced a reduction of their symptoms following training.

The Danish anal sphincter rupture questionnaire: validity and reliability.

OBJECTIVE: To revise, validate and test for reliability an anal sphincter rupture questionnaire in relation to construct, content and face validity. SETTING AND BACKGROUND: Since 1996 women with anal sphincter rupture (ASR) at one of the public university hospitals in Copenhagen, Denmark have been offered pelvic floor muscle examination and instruction by a specialist physiotherapist. In relation to that, a non-validated questionnaire about anal and urinary incontinence was to be answered six months after childbirth. METHOD: The original questionnaire was revised and a pilot test was performed among health care personnel, followed by an expert panel discussion. Ten women were interviewed about their understanding and attitude toward answering the questionnaire and it was pre-tested on 52 women with ASR. The questionnaire was revised five times during the validation process. The final version was test-retested among 20 women with ASR. RESULTS: The questionnaire revealed typical problems after ASR. The length, use of language, and the way the questionnaire was constructed, was deemed appropriate. The reliability test showed good to very good correlation (Kappa values from 0.733 to 0.923) in all main questions but one. Two questions needed further explanation. Seven women made minor errors. CONCLUSION: The validated Danish questionnaire has a good construct, content and face validity. It is a well accepted, reliable, simple and clinically relevant screening tool. It reveals physical problems including sexual problems, impact on quality of life and need for treatment among women 6-8 months after ASR.