Original Title: Avis - La rééducation périnéale et pelvienne pour la prévention et le traitement des dysfonctions du plancher pelvien : Volet 2 – Dysfonction anorectale, prolapsus des organes pelviens et douleurs périnéales chez la femme

Authors' objectives: Pelvic floor dysfunctions significantly impact on physical, psychological, sexual and social quality of life. Their prevalence is often underestimated because of the reluctance and embarrassment to discuss these symptoms. The costs associated with pelvic floor dysfunctions in women are substantial, and they constitute an economic burden for society [Sung et al., 2010]. Conservative treatments, such as perineal and pelvic rehabilitation, including pelvic floor muscle training (PFMT) are usually proposed as firstline options to treat these disorders in women, and surgical procedures may be proposed if conservative and pharmacological treatments fail. The Ministère de la Santé et des Services sociaux (MSSS) asked the Institut national d'excellence en santé et en services sociaux (INESSS) to evaluate the advisability of including perineal and pelvic rehabilitation in the range of public services offered in Québec to prevent and treat pelvic floor dysfunctions. The request specifically concerned the efficacy of perineal and pelvic rehabilitation, the risks, the conditions of use, and the economic and organizational impact. In Part 1 of this project, INESSS issued a favourable recommendation regarding access to perineal and pelvic rehabilitation for the prevention and treatment of urinary incontinence, one of the common sequelae of pelvic floor dysfunction. In the continuation of the project, presented in this report, we examine and make recommendations regarding access to perineal and pelvic rehabilitation for the prevention and treatment of anorectal dysfunctions, pelvic organ prolapse, and perineal pain.

Authors' results and conclusions: RESULTS: (#1 ANORECTAL DYSFUNCTIONS ): Perineal and pelvic rehabilitation may be more effective than standard care (without medication) in treating fecal incontinence in adult women. However, the level of evidence is considered low because of the small number of studies, which are of low quality. The clinical practice guidelines recommend perineal and pelvic rehabilitation after initial treatments have failed. • There appears to be no difference in efficacy between perineal and pelvic rehabilitation and loperamide or anal injections of dextranomer for treating fecal incontinence in adult women. However, the level of evidence is considered low because of the small number of studies, which are of low quality. (#2 PELVIC ORGAN PROLAPSE): Perineal and pelvic rehabilitation appears to be effective as a first-line treatment for pelvic organ prolapse (stages I to III) in reducing the severity of anterior vaginal wall prolapse and the overall symptoms of pelvic organ prolapse in the short term (moderate level of evidence). • The clinical practice guidelines unanimously recommend the use of perineal and pelvic rehabilitation for the treatment of stage I and II pelvic organ prolapse. (#3 PERINEAL PAIN): Perineal and pelvic rehabilitation may be more effective than topical lidocaine, botulinum toxin injections, or steroid and analgesic injections in improving sexual function in adult women with perineal pain. However, the level of evidence is considered low because of the small number of studies, which are of low quality. • The clinical practice guidelines recommend perineal and pelvic rehabilitation, alone or in combination with other conservative approaches, for the treatment of perineal pain, including vulvodynia, in adult women. • Despite the low level of evidence, the experts consulted believe that perineal and pelvic rehabilitation is clinically useful for the treatment of anorectal dysfunctions and perineal pain. In their opinion, the lack of efficacy data should not prevent Québec health professionals from recommending it to their patients on a first-line basis, especially since it is safe and noninvasive. (#4 ORGANIZATIONAL ISSUES): As in Part 1 of the project, a need to organize care to facilitate equitable access for women who might benefit from perineal and pelvic rehabilitation was identified. • Among the options that could improve access to perineal and pelvic rehabilitation are digital health (e.g., telerehabilitation) and group sessions. However, these modalities should be evaluated to ensure their efficacy, safety and applicability. • It was reiterated by the stakeholders consulted that the contribution of professionals from different disciplines could support optimal patient management. • There appears to be a need for easily accessible resources to inform the public about pelvic floor issues and the available treatments, particularly perineal and pelvic rehabilitation. (#5 PATIENT PERSPECTIVE): Several obstacles can prevent women from seeking medical attention or undertaking treatment in the form of perineal and pelvic rehabilitation: conflicting and patchy information on pelvic floor dysfunctions and perineal and pelvic rehabilitation, embarrassment, difficulty getting an appointment to discuss them, difficulty accessing perineal and pelvic rehabilitation, and costs. • Women in Québec who have undergone treatment in the form of perineal and pelvic rehabilitation report that it: – Helps prevent the occurrence or worsening of symptoms of pelvic floor dysfunction and helps improve their daily well-being; – Provides better control of their pelvic floor muscles and enables them to manage other associated symptoms, such as pelvic pain; – Enables them to resume their daily activities quickly, facilitates delivery and reduces the trauma of childbirth. (#6 ECONOMIC ASPECTS COST-EFFECTIVENESS): According to the only economic study found in the literature that was considered transferable to the Québec clinical context, perineal and pelvic rehabilitation for the treatment of pelvic organ prolapse in adult women is associated with costeffectiveness ratios (incremental cost-utility ratio) that are lower than the generally accepted cost-effectiveness thresholds. In particular, treatment sequences that include management initially consisting of perineal and pelvic rehabilitation are generally less expensive and more effective than one that does not include perineal and pelvic rehabilitation. • The cost-effectiveness of perineal and pelvic rehabilitation for the treatment of anorectal dysfunctions and perineal pain in adult women could not be evaluated from the economic literature found. (#6.1 ECONOMIC ASPECTS BUDGET IMPACT): Based on the various assumptions used, the introduction of public coverage for perineal and pelvic rehabilitation in Québec for the treatment of pelvic organ prolapse in adult women could generate, depending on the number of sessions done (between 4 and 10), a net impact of $17 to $30 million, would concern 118,000 women and would make it possible to treat approximately 56,000 additional cases of pelvic organ prolapse over 5 years. • Given the uncertainty regarding the efficacy of perineal and pelvic rehabilitation for the treatment of anorectal dysfunctions and perineal pain, the impact of PPR on the use of subsequent treatments could not be assessed. In 5 years, the public offer of perineal and pelvic rehabilitation could lead to: – For the treatment of anorectal dysfunctions in adult women, expenditures of $107 to $206 million, depending on the number of sessions (between 6 and 12), and would concern 202,000 women; – For the treatment of perineal pain, expenditures of $118 to $176 million, depending on the number of sessions (between 8 and 12), and would concern 134,000 women.

Authors' recommendations: RESULTS: (#1 ANORECTAL DYSFUNCTIONS ): Perineal and pelvic rehabilitation may be more effective than standard care (without medication) in treating fecal incontinence in adult women. However, the level of evidence is considered low because of the small number of studies, which are of low quality. The clinical practice guidelines recommend perineal and pelvic rehabilitation after initial treatments have failed. • There appears to be no difference in efficacy between perineal and pelvic rehabilitation and loperamide or anal injections of dextranomer for treating fecal incontinence in adult women. However, the level of evidence is considered low because of the small number of studies, which are of low quality. (#2 PELVIC ORGAN PROLAPSE): Perineal and pelvic rehabilitation appears to be effective as a first-line treatment for pelvic organ prolapse (stages I to III) in reducing the severity of anterior vaginal wall prolapse and the overall symptoms of pelvic organ prolapse in the short term (moderate level of evidence). • The clinical practice guidelines unanimously recommend the use of perineal and pelvic rehabilitation for the treatment of stage I and II pelvic organ prolapse. (#3 PERINEAL PAIN): Perineal and pelvic rehabilitation may be more effective than topical lidocaine, botulinum toxin injections, or steroid and analgesic injections in improving sexual function in adult women with perineal pain. However, the level of evidence is considered low because of the small number of studies, which are of low quality. • The clinical practice guidelines recommend perineal and pelvic rehabilitation, alone or in combination with other conservative approaches, for the treatment of perineal pain, including vulvodynia, in adult women. • Despite the low level of evidence, the experts consulted believe that perineal and pelvic rehabilitation is clinically useful for the treatment of anorectal dysfunctions and perineal pain. In their opinion, the lack of efficacy data should not prevent Québec health professionals from recommending it to their patients on a first-line basis, especially since it is safe and noninvasive. (#4 ORGANIZATIONAL ISSUES): As in Part 1 of the project, a need to organize care to facilitate equitable access for women who might benefit from perineal and pelvic rehabilitation was identified. • Among the options that could improve access to perineal and pelvic rehabilitation are digital health (e.g., telerehabilitation) and group sessions. However, these modalities should be evaluated to ensure their efficacy, safety and applicability. • It was reiterated by the stakeholders consulted that the contribution of professionals from different disciplines could support optimal patient management. • There appears to be a need for easily accessible resources to inform the public about pelvic floor issues and the available treatments, particularly perineal and pelvic rehabilitation. (#5 PATIENT PERSPECTIVE): Several obstacles can prevent women from seeking medical attention or undertaking treatment in the form of perineal and pelvic rehabilitation: conflicting and patchy information on pelvic floor dysfunctions and perineal and pelvic rehabilitation, embarrassment, difficulty getting an appointment to discuss them, difficulty accessing perineal and pelvic rehabilitation, and costs. • Women in Québec who have undergone treatment in the form of perineal and pelvic rehabilitation report that it: – Helps prevent the occurrence or worsening of symptoms of pelvic floor dysfunction and helps improve their daily well-being; – Provides better control of their pelvic floor muscles and enables them to manage other associated symptoms, such as pelvic pain; – Enables them to resume their daily activities quickly, facilitates delivery and reduces the trauma of childbirth. (#6 ECONOMIC ASPECTS COST-EFFECTIVENESS): According to the only economic study found in the literature that was considered transferable to the Québec clinical context, perineal and pelvic rehabilitation for the treatment of pelvic organ prolapse in adult women is associated with costeffectiveness ratios (incremental cost-utility ratio) that are lower than the generally accepted cost-effectiveness thresholds. In particular, treatment sequences that include management initially consisting of perineal and pelvic rehabilitation are generally less expensive and more effective than one that does not include perineal and pelvic rehabilitation. • The cost-effectiveness of perineal and pelvic rehabilitation for the treatment of anorectal dysfunctions and perineal pain in adult women could not be evaluated from the economic literature found. (#6.1 ECONOMIC ASPECTS BUDGET IMPACT): Based on the various assumptions used, the introduction of public coverage for perineal and pelvic rehabilitation in Québec for the treatment of pelvic organ prolapse in adult women could generate, depending on the number of sessions done (between 4 and 10), a net impact of $17 to $30 million, would concern 118,000 women and would make it possible to treat approximately 56,000 additional cases of pelvic organ prolapse over 5 years. • Given the uncertainty regarding the efficacy of perineal and pelvic rehabilitation for the treatment of anorectal dysfunctions and perineal pain, the impact of PPR on the use of subsequent treatments could not be assessed. In 5 years, the public offer of perineal and pelvic rehabilitation could lead to: – For the treatment of anorectal dysfunctions in adult women, expenditures of $107 to $206 million, depending on the number of sessions (between 6 and 12), and would concern 202,000 women; – For the treatment of perineal pain, expenditures of $118 to $176 million, depending on the number of sessions (between 8 and 12), and would concern 134,000 women.

Authors' methods: A search of the scientific literature and other information sources was conducted: an umbrella review, an exploratory review, or a review of the clinical practice guidelines, depending on the evaluation question. The economic literature was reviewed to assess the cost-effectiveness of perineal and pelvic rehabilitation, using studies deemed transferable to the Québec context. A budget impact analysis was performed to estimate the impact of adding perineal and pelvic rehabilitation to the range of publicly funded services available in Québec for the treatment of each pelvic floor dysfunction. The work was supported by an advisory committee of experts, a committee of patient collaborators, and a follow-up committee. In order to mobilize and integrate the knowledge, a multidimensional approach was used in which scientific, contextual and experiential data were integrated. The statements of scientific evidence that were drawn up were subjected to grading of the quality of evidence. The recommendations were deliberated on by the Comité délibératif permanent − Modes d’intervention en santé.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/la-reeducation-perineale-et-pelvienne-pour-la-prevention-et-le-traitement-des-dysfonctions-du-plancher-pelvien.html

Year Published: 2023

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/la-reeducation-perineale-et-pelvienne-pour-la-prevention-et-le-traitement-des-dysfonctions-du-plancher-pelvien.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)