- https://doi.org/10.1097/cu9.0000000000000237
Diagnosis and treatment of pelvic organ prolapse complicated with stress urinary incontinence: A Chinese expert consensus
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Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) share common pathological mechanisms,[1] and both manifest as a tape of pelvic floor dysfunction, often co-occurring and developing concomitantly. Although POP develops concomitantly with evident SUI in some cases, there have been instances wherein POP occurs without prior urine leakage before repositioning the prolapsed organs, but urinary incontinence develops after the prolapsed organs are repositioned. The condition in such cases is termed as occult SUI (OSUI), with an incidence of approximately 23.5% among patients with POP.[2] 1. Epidemiology and pathological mechanisms Despite sharing several epidemiological risk factors such as pregnancy, increased gravidity and parity, obesity, advanced age, persistently elevated intra-abdominal pressures (IAP) (eg, persistent cough or constipation), menopause, and family history, POP and SUI have complex and multifactorial etiologies. Furthermore, advanced age and Green type III cystocele (bladder prolapses to the level of the urinary meatus, the posterior urethrovesical angle <140°, urethral rotation angle ≥45°) are risk factors for concomitant OSUI in patients with POP.[3] Although POP and SUI represent distinct clinical manifestations with a shared cause, which is currently believed to be a class of disorders linked to an imbalance of pelvic floor dynamics, the majority of POP cases involve the anterior vaginal wall or the bladder. This type of prolapse is highly likely to result in laxity and protrusion of the bladder's neck and posterior wall, causing impaired support from the middle posterior urethra. This, in turn, leads to a reduced functional length of the urethra and the development of SUI symptoms.[4] Although current surgical procedures for POP repositioning can correct the anatomical positions of the involved organs, they cannot address problems involving the mechanisms of urinary control, such as sphincter dysfunction, thinning of the urethral mucosa, and autonomic dysfunction of the involved organs. Consequently, SUI becomes particularly prominent in the postoperative period.[5,6] Biomechanical finite element analyses of the pathological mechanisms of pelvic floor stress dysfunction reveal that SUI and POP are disorders of mechanical imbalance inexorably linked to each other. Moreover, they serve as pelvic manifestations of the overall systemic deterioration of the body's mechanical properties. Achieving optimal therapeutic efficacy requires more than just correcting SUI or POP in isolation. It necessitates restoring the overall health of the body and its mechanics through a comprehensive understanding of the body's overall condition and mechanical imbalance post–pelvic floor stress dysfunction.[7,8] 2. Diagnosis and evaluation The diagnosis of POP accompanied by SUI primarily relies on a thorough medical history and specialized examination. Questionnaires and laboratory examinations are not suitable for clear differential diagnosis from POP or SUI alone. 2.1. Medical history The typical symptom of POP accompanied by SUI involves protrusion of a mass from the vagina that can be seen, palpated, or otherwise sensed, which may also be accompanied by urine leakage during activities that increase IAP, such as exercise, laughing, coughing, or sneezing. Some patients may also present with frequent urination, urinary urgency, urge incontinence, or difficult urination. 2.2. Specialist examination Patients should be positioned in lithotomy or, if necessary, a standing position for examination. Observation includes checking for urinary leakage from the external urethral meatus, prolapse of pelvic organs, and maximum extent of organ prolapse at rest, during coughing or breath holding. Results should be recorded using the POP-Q system. Vaginal repositioning testing should be performed to avoid missing a diagnosis of OSUI. Specifically, stress induction testing should be performed after repositioning of the prolapsed organs, preferably in the standing position if possible. In addition, pad weight testing should be performed as a preliminary evaluation of urine leakage. Many methods of repositioning are available, with reliable results achieved by restoring the normal position of the vagina using an appropriately sized pessary or sterile cotton gauze.[9,10] 2.3. Urodynamic testing The 2019 National Institute for Health and Care Excellence guidelines serve as the international consensus to determine whether urodynamic testing is required in cases of POP accompanied by SUI. Urodynamic testing is currently recommended in the following situations: (1) mixed urinary incontinence or urinary incontinence of unknown cause; (2) voiding dysfunction as the primary symptom; (3) SUI with concomitant anterior or apical prolapse; (4) previous history of surgical treatment for urinary incontinence. Notably, this testing should be conducted only after repositioning of the prolapsed pelvic organs, distinguishing it from other urodynamic testing methods. 2.4. Differential diagnosis It is necessary to differentiate among the types of urinary incontinence associated with pelvic organ prolapse, primarily including the following: Urge incontinence: Involuntary urine leakage associated with a strong and sudden need to urinate, rather than leakage triggered by activities such as coughing or sneezing that elevate intra-abdominal pressure. Overflow incontinence: Involuntary leakage of urine due to an overdistended bladder. This is commonly encountered in cases of chronic urinary retention caused by various factors, resulting in continuous or intermittent urine leakage when bladder pressure exceeds urethral resistance. Genuine stress incontinence: A loss of urine due to a rise in intra-abdominal pressure, even when the bladder is not full. Common causes include urethral sphincter damage and congenital or acquired neurogenic diseases. 3. Conservative treatment Conservative treatment is recommended for patients with POP of grade ≤2, as assessed by the POP-Q, accompanied by mild or moderate SUI. The selection of treatment depends on the patient's preferences, disease severity, the benefits and risks of the chosen treatment, and other relevant factors. Various treatment methods are available, including follow-up observation, lifestyle interventions, pelvic floor muscle training (PFMT), pelvic floor physical therapy, pessaries, medication, and traditional Chinese medicine and acupuncture. 3.1. Follow-up observation Follow-up observation is a suitable option for asymptomatic patients, but it should be accompanied by lifestyle intervention guidance and health education. 3.2. Lifestyle interventions All patients diagnosed with POP accompanied by SUI should actively receive behavioral guidance to mitigate factors that exacerbate pelvic floor injury. This may involve weight loss, smoking cessation, avoidance of activities that increase pelvic floor stress, and the treatment of constipation and cough. 3.3. Pelvic floor muscle training Numerous PFMT methods are available, with Kegel exercises being simple yet effective in increasing the strength and coordination of weak pelvic floor muscles. Currently, a recommended duration of 3 continuous months of muscle training is advised for improving pelvic floor dysfunction, especially in cases of mild or moderate SUI.[11,12] 3.4. Physical therapy Biofeedback, adjuvant electrical stimulation, and electromagnetic therapy can enhance the effectiveness of PFMT and shorten the duration of therapy. 3.5. Pessaries Pessaries are devices inserted into the vagina to enhance pelvic floor function by restoring the normal anatomical positions of the uterus, vaginal wall, urethra, and bladder. They represent a first-line conservative treatment option for POP. Specifically, pessaries designed to address urinary incontinence can alleviate the majority of symptoms in patients with mild to moderate POP accompanied by SUI[13] and are particularly suitable for patients with fertility requirements or those for whom surgery is contraindicated. However, proper guidance on usage and regular follow-up visits are essential. 3.6. Medication Generally, medication is not considered a first-line treatment for POP accompanied by SUI. However, local estrogen treatment may be considered if the patient presents with genitourinary syndrome of menopause, which can help alleviate vaginal dryness, reduce urinary tract symptoms, and increase the thickness of the urethral mucosa, indirectly improving symptoms of urinary incontinence.[14] 3.7. Traditional Chinese medicine Electroacupuncture, traditional Chinese medicine, and other procedures can improve pelvic floor support and alleviate symptoms of prolapse and urinary incontinence to some extent, serving as adjuvant treatments. 4. Surgical treatment of POP with SUI Nearly 70% of patients with severe POP exhibit symptoms of SUI.[15] For POP patients with evident SUI, surgical treatments solely addressing POP have limited efficacy for SUI. Hence, we recommend simultaneous surgical treatment of SUI (evidence grade C). Surgical interventions for SUI encompass midurethral slings (MUS) and Burch colposuspension (Burch procedure). 4.1. Midurethral sling Midurethral sling corrects urinary incontinence by strengthening the overactive middle segment of the urethra. With a subjective cure rate of 75%–94% and an objective cure rate of 57%–92% for SUI, MUS stands as a superior treatment for urinary incontinence compared with the Burch procedure, establishing itself as the criterion standard for surgical treatment of female SUI. Medical evidence indicates that, in POP patients with evident SUI preoperatively, simultaneous MUS during pelvic floor reconstruction can reduce the subjective incidence of postoperative SUI and further decrease the need for surgical management of SUI.[16] For SUI patients with characteristics such as small bladder volume, urinary retention, or detrusor muscle dysfunction, preoperative urodynamic testing should be conducted to assess bladder function, and the option of surgical SUI management should be carefully considered. In cases where MUS is performed simultaneously with surgical POP management, it is recommended to tighten the sling and adjust tension after completing pelvic floor reconstruction. Complications of MUS may include bladder and urethral injury, difficult urination, pain in the medial thigh and pelvic cavity, and mesh exposure or erosion. 4.2. Burch procedure The Burch procedure addresses urinary incontinence by elevating the neck of the bladder and restoring the posterior urethrovesical angle. It is currently employed in laparoscopic POP reconstruction when surgical SUI management is necessary. Studies have demonstrated that patients undergoing the Burch procedure exhibit significantly lower overall cure rate and objective cure rate than those undergoing MUS. Thus, the Burch procedure is not considered the first choice for surgical SUI management in patients with POP accompanied by SUI. 5. Surgical treatment of POP with OSUI The choice between a "one-step" and a "two-step" treatment for POP accompanied by OSUI remains a matter of debate. Conducting MUS simultaneously with the surgical management of POP has shown advantages, such as reducing the risk of new-onset SUI postoperation, diminishing the need for postoperative SUI treatment, decreasing the requirements of anesthesia, and lowering medical costs. In addition, it does not affect the patient's ability to void and retain urine, nor does it compromise bladder compliance. However, this approach is associated with an increased incidence of overactive bladder, difficult urination, urine retention, urinary tract infections, and elevated risks of sling erosion and bladder perforation.[17,18] Pelvic organ prolapse patients lacking symptoms of SUI are particularly susceptible to developing OSUI, especially in cases of anterior and central POP. Preoperatively, prolapsed tissues should be repositioned through the vagina before detailed examination to confirm the presence or absence of OSUI to prevent postoperative SUI. We recommend the following methods in the formulation of the surgical plan (Fig. 1): For patients with POP in which SUI was not preoperatively confirmed, vaginal repositioning testing should be performed first. If the result is negative, SUI surgery is not necessary. If the result is positive, the strategy should be formulated considering whether the patient has a previous history of SUI. For patients with a confirmed history of SUI that resolved with increasing prolapse and for those without a history of SUI who do not wish to undergo a second operation, simultaneous SUI surgery can be performed. In summary, patients with POP accompanied by OSUI should be examined on an individual basis to weigh the risks and benefits, the surgical procedure should be carefully selected, and communications with the patient and family members should be timely and thorough.Figure 1: Diagnostic flowchart for POP accompanied by OSUI. POP = pelvic organ prolapse; SUI = stress urinary incontinence. POP = pelvic organ prolapse; SUI = stress urinary incontinence.If simultaneous SUI surgery is deemed necessary, the primary options include both the Burch procedure and MUS, with the choice dependent on the surgical approach for POP (transabdominal or transvaginal). Notably, the efficacy of MUS is better than that of the Burch procedure, and the effectiveness of MUS via the retropubic approach or the transobturator approach is comparable. 6. Prevention and surveillance 6.1. Prevention Pelvic organ prolapse and SUI have the same epidemiological risk factors and therefore similar preventive measures. Improving health during pregnancy and the postpartum period through interventions such as weight control and PFMT exercises combined with breathing exercises.[19] Avoiding activities that increase IAP, such as managing constipation and minimizing intense physical activity. Controlling body weight, avoiding/quitting smoking, and maintaining nutritional balance. Postmenopausal patients can undergo appropriate hormone replacement therapy after evaluation by a physician, thus improving overall health and managing symptoms of genitourinary syndrome of menopause. 6.2. Surveillance Surveillance of patients with POP accompanied by SUI should include the following: Follow-up for conservative treatment: At 3–6 months of treatment, follow-up should include a 72-hour voiding diary, a 1-hour urine pad test, pelvic floor muscle myoelectric testing, the International Consultation on Incontinence Questionnaire—Urinary Incontinence Short Form (ICI-Q-SF), and urodynamic testing if necessary.[20] Follow-up for surgical treatment: At 6 months postoperatively, the patient should be examined for short-term complications such as infection, bleeding, and tissue injury. After 6 months, the patient should be examined for long-term complications and efficacy of surgical treatment. Follow-up examination should include a 72-hour voiding diary, a 1-hour urine pad test, the ICI-Q-SF, Pelvic Floor Distress Inventory-20, Pelvic Organ Prolapse Distress Inventory-6, Urinary Distress Inventory-6 Colorectal-Anal Distress Inventory-8, Pelvic Floor Impact Questionnaire-7, the American Urological Association Symptom Score, and other questionnaires, as well as urodynamic testing, B-scan ultrasound of the pelvic floor, cystography, and other examinations as necessary to evaluate bladder function and mechanical recovery of the pelvic floor. Patients with mesh exposure should be referred to a trained and experienced pelvic floor specialist for further diagnosis and treatment.[21] The use of standardized CTS terminology and standardized documentation for complications is recommended to facilitate future management and referral. This article is a second publication and English translation of Chinese expert consensus on the diagnosis and treatment of pelvic organ prolapse and stress urinary incontinence, which was first published in Zhonghua Miniao Waike Zazhi, 2023, 44(6):401–404. doi: 10.3760/cma.j.cn12330-20230516-00172
- Research Article
2 - 10.1111/j.1442-2042.2009.02347.x
- Jul 29, 2009
- International Journal of Urology
When I was a resident, my leader taught me that the gold standard forpatients with stress incontinence is the Marshall–Marchetti–Krantz(MMK) procedure. But a few years later, urologists who could performadvanced techniques showed me needle suspension as the best methodat a urological meeting. Fortunately my boss gave me a chance for ahand-to-hand lesson of the stamay procedure by the specialist. Sincethen, I have been selecting this procedure for a few years. Withoutdoubt, this needle suspension was the gold standard at that time.But now most urologists do not select this technique because of badresults. After I had mastered the technique of tension-free vaginal tape(TVT), I could see the smiling faces of patients after the operation. Atthat time I believed that TVT would be the gold standard for thiscondition. But the present status is what you know.Recently most specialists, including myself, believe that using‘mesh’ is the best operation for patients with pelvic organ prolapse. Isthis tendency good for the patients in the long run? No one can predictthe results of this procedure more than ten years from now.God knows what procedure will be the gold standard in the future.Assistant Professor Yasuyuki Suzuki
- Research Article
- 69
- 10.1007/s00192-015-2924-1
- Jan 6, 2016
- International Urogynecology Journal
We compared pelvic organ prolapse (POP) repair with and without midurethral sling (MUS) in women with occult stress urinary incontinence (SUI). This was a randomized trial conducted by a consortium of 13 teaching hospitals assessing a parallel cohort of continent women with symptomatic stage II or greater POP. Women with occult SUI were randomly assigned to vaginal prolapse repair with or without MUS. Women without occult SUI received POP surgery. Main outcomes were the absence of SUI at the 12-month follow-up based on the Urogenital Distress Inventory and the need for additional treatment for SUI. We evaluated 231 women, of whom 91 randomized as follows: 43 to POP surgery with and 47 without MUS. A greater number of women in the MUS group reported absence of SUI [86% vs. 48%; relative risk (RR) 1.79; 95% confidence interval (CI) 1.29-2.48]. No women in the MUS group received additional treatment for postoperative SUI; six (13%) in the control group had a secondary MUS. Women with occult SUI reported more urinary symptoms after POP surgery and more often underwent treatment for postoperative SUI than women without occult SUI. Women with occult SUI had a higher risk of reporting SUI after POP surgery compared with women without occult SUI. Adding a MUS to POP surgery reduced the risk of postoperative SUI and the need for its treatment in women with occult SUI. Of women with occult SUI undergoing POP-only surgery, 13% needed additional MUS. We found no differences in global impression of improvement and quality of life.
- Research Article
- 149
- 10.1002/14651858.cd013108
- Aug 19, 2018
- The Cochrane database of systematic reviews
In women with POP and SUI (symptomatic or occult), a concurrent MUS probably reduces postoperative SUI and should be discussed in counselling. It might be feasible to postpone the MUS and perform a delayed (two-stage) continence procedure, if required.Although an abdominal continence procedure (Burch colposuspension) during abdominal POP surgery in continent women reduced de novo SUI rates in one underpowered trial, another RCT reported conflicting results. Adding an MUS during vaginal POP repair might reduce postoperative development of SUI.An anterior native tissue repair might be better than use of transobturator mesh for preventing postoperative SUI; however, prolapse recurrence is more common with native tissue repair.
- Research Article
- 10.3760/cma.j.issn.0529-567x.2015.06.004
- Jun 1, 2015
- Zhonghua fu chan ke za zhi
To investigate the correlation between pelvic organ prolapse quantitation (POP-Q) indication points and the incidence of occult stress urinary incontinence (OSUI) and its impact on prognosis. Retrospective study medical records of 93 patients with pelvic organ prolapse (POP) staged at III-IV, of which underwent pelvic reconstruction operations with Prolift system from Jan. 2007 to Sept. 2012. None of these patients had clinical manifestations of stress urinary incontinence (SUI) before surgery, and in which 44 patients were included in study group (POP complicated with OSUI) because they were identified with OSUI, another 49 patients as control group (simple POP). Follow-up and collecting datas including POP-Q, stress test, urodynamic recordings, incidence of de novo SUI, statistic analyzing by logistic regression and receiver operating characteristic curve (ROC). (1) The study group had a much higher incidence of 30% (13/44) on de novo SUI than that of control group (4%, 2/49; P < 0.01). (2) Vaginal delivery (OR = 5.327, 95% CI: 1.120-25.347), constipation (OR = 5.789, 95% CI: 1.492-22.459), preoperative OSUI (OR = 13.695, 95% CI: 2.980-62.944), anterior vaginal wall prolapse (OR = 6.115, 95% CI: 1.231-30.379) were identified as dependent risk factors for de novo SUI by logistic regression analysis. (3) For POP patients that complicated with OSUI, we chose a cutoff value of +1.5 cm for Aa point as the threshold to predicting incidence of de novo SUI according to ROC curve, area under the curve (AUC) was 0.889 (P < 0.05), the sensitivity reached 88.9% and specificity was 73.9%. According to ROC curve of Ba point, a cutoff value of +2.5 cm was chosen as the threshold to predicting incidence of de novo SUI post-operation, it had a sensitivity of 66.7% and specificity of 82.6%, AUC was 0.766 (P < 0.05). Pre-operative OSUI is a dependent risk factor of de novo SUI for advanced POP patients. Aa and Ba points are correlated with preoperative OSUI, and it is worthy to be considered as a risk predictor on forecasting the incidence of de novo SUI post pelvic reconstruction surgery.
- Research Article
- 10.1097/ju.0000000000003222.11
- Apr 1, 2023
- Journal of Urology
MP07-11 IMPACT OF PREOPERATIVE URODYNAMICS ON THE SURGICAL TREATMENT OF ADVANCED PELVIC ORGAN PROLAPSE
- Research Article
- 10.3760/cma.j.issn.0529-567x.2014.06.008
- Jun 1, 2014
- Zhonghua fu chan ke za zhi
To evaluate the clinical outcome of anti-incontinence sling in the treatment of occult stress urinary incontinence (OSUI) during reductive surgery for advanced pelvic organ prolapse (POP). From Jun. 2003 to Dec. 2012, 78 patients with OSUI underwent reductive surgery for advanced POP such as high uterosacral ligament suspension, sacrospinous ligament suspension and sacral colpopexy in the First Affiliated Hospital, General Hospital of People's Liberation Army. Among them, 41 patients received reductive surgery alone was enrolled in non-concomitant anti-incontinence group and the other 37 patients who underwent same surgery with tension-free vaginal tape (TVT) or tension-free vaginal tape-obturator technique (TVT-O) was in anti-incontinence group. The patient's demography, objective and subjective outcomes, as well as complications and injures were compared between the two groups. The pelvic organ prolapse quantitation (POP-Q) was used to evaluate the objective outcomes of POP. Urinary distress inventory (UDI-6) and incontinence impact questionnaire short form (IIQ-7) were used to evaluate the subjective outcomes of stress urinary incontinence (SUI). Compared with the non-concomitant anti-incontinence group, the objective outcomes of reductive surgery exhibited no significant differences (100%, 78/78), and only the operation time of anti-incontinence group slightly increased 16 minutes. The occurrence rate of postoperative SUI was 12% (5/41), 15% (6/41), 17% (7/41) respectively after the operation at 2-month, 6-month and 12-month follow up in the non-concomitant anti-incontinence group; and the occurrence rate of the anti-incontinence group was 3% (1/37), 3% (1/37), 3% (1/37); but none of patients in the two groups require further surgery for stress urinary incontinence. Mean score of UDI-6 and IIQ-7 in all the patients decreased significantly after operation at 2-month, 6-month and 12-month follow up (all P < 0.01). However, there was no statistic difference between the two groups (P > 0.05). It is still difficult to make decision for concomitant anti-incontinence procedure in those patients with OSUI, who are undergoing reductive surgery because of advanced POP. Whether the patients will benefit more from anti-incontinence sling depends largely on strict preoperative evaluation for the severity of SUI. The patients with severe SUI are supposed to benefit most from anti-incontinence sling. However, a two-step approach to correct the postoperative stress urinary incontinence is also reasonable.
- Front Matter
- 334
- 10.1016/j.juro.2017.06.061
- Jun 15, 2017
- Journal of Urology
Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline
- Research Article
- 18
- 10.1002/nau.25551
- Jul 9, 2024
- Neurourology and urodynamics
Today there is Level 1, recommendation A for pelvic floor muscle training (PFMT) to be effective in treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). However, the mechanisms of action are discussed. The aim of the present overview was to give an update of studies evaluating the effect of PFMT on pelvic floor morphology and associations between changes in PFM strength and symptoms of female SUI and POP. MATERIALS ANDMETHODS: This was a narrative review retrieving studies from systematic reviews of PFMT for SUI and POP. In addition, an open search on PubMed with the search terms PFMT and morphology was conducted. Both randomized controlled trials (RCTs) and pre-posttest design studies were included. PEDro rating scale (0-10) was used to assess risk of bias. Ten studies were found reporting on morphological changes after PFMT. The four RCTs had PEDro score between 5 and 8/10. The studies found significant higher bladder neck position and narrower levator hiatus dimensions, thicker external urethral sphincter, increased cross-sectional area of PFM, improvement in PFM tears and blood flow. Twenty studies analyzed associations between changes in different PFMT variables and SUI and POP. Eleven studies found a positive weak to moderate association and six studies reported no association. Studies comparing responders and nonresponders to PFMT found statistically significant better PFM variables in responders. PFMT can change pelvic floor muscle and external urethral sphincter anatomy. This contributes to the understanding on how PFMT can be effective in prevention and treatment of SUI and POP.
- Research Article
- 61
- 10.1016/j.juro.2011.01.078
- Apr 16, 2011
- Journal of Urology
Pelvic Organ Prolapse Repair With and Without Prophylactic Concomitant Burch Colposuspension in Continent Women: A Randomized, Controlled Trial With 8-Year Followup
- Research Article
- 54
- 10.3310/hta24700
- Dec 1, 2020
- Health Technology Assessment
Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. This trial was set in UK community and outpatient care settings. Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. Current Controlled Trial ISRCTN57746448. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.
- Research Article
- 90
- 10.1016/j.juro.2007.05.147
- Aug 17, 2007
- Journal of Urology
Outcomes Following Repeat Mid Urethral Synthetic Sling After Failure of the Initial Sling Procedure: Rediscovery of the Tension-Free Vaginal Tape Procedure
- Research Article
- 272
- 10.1016/j.juro.2008.07.029
- Sep 17, 2008
- Journal of Urology
Complications of Mid Urethral Slings: Important Outcomes for Future Clinical Trials
- Research Article
- 142
- 10.1016/j.juro.2011.06.054
- Sep 25, 2011
- Journal of Urology
Alterations in Connective Tissue Metabolism in Stress Incontinence and Prolapse
- Research Article
- 8
- 10.1016/j.purol.2016.03.003
- Apr 5, 2016
- Progrès en Urologie
Impact de la promonto-fixation cœlioscopique, avec ou sans bandelette sous-urétrale, sur les symptômes du bas appareil urinaire
- Research Article
- 206
- 10.1007/s00345-011-0779-8
- Oct 9, 2011
- World Journal of Urology
The objectives of the present review was to present and discuss evidence for pelvic floor muscle (PFM) training on female stress urinary incontinence (SUI), pelvic organ prolapse (POP) and sexual dysfunction. This manuscript is based on conclusions and data presented in systematic reviews on PFM training for SUI, POP and sexual dysfunction. Cochrane reviews, the 4th International Consultation on Incontinence, the NICE guidelines and the Health Technology Assessment were used as data sources. In addition, a new search on Pubmed was done from 2008 to 2011. Only data from randomized controlled trials (RCTs) published in English language is presented and discussed. There is Level 1, Grade A evidence that PFM training is effective in treatment of SUI. Short-term cure rates assessed as <2g of leakage on pad testing vary between 35 and 80%. To date there are 5 RCTs showing significant effect of PFM training on either POP stage, symptoms or PFM morphology. Supervised and more intensive training is more effective than unsupervised training. There are no adverse effects. There is a lack of RCTs addressing the effect of PFM training on sexual dysfunction. PFM training should be first line treatment for SUI and POP, but the training needs proper instruction and close follow-up to be effective. More high quality RCTs are warranted on PFM training to treat sexual dysfunction.
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