A Clinical Consensus Treatment Algorithm for Patients with High-tone Pelvic Floor Dysfunction: a Multidisciplinary Delphi Study

BACKGROUND High-tone pelvic floor dysfunction (HTPFD) is a neuromuscular disorder of the pelvic floor characterized by non-relaxing pelvic floor muscles, resulting in lower urinary tract and defecatory symptoms, sexual dysfunction, and pelvic pain. Despite affecting 80% of women with chronic pelvic pain, there are no uniformly accepted guidelines to direct the management of these patients. We sought to develop evidence-and consensus-based clinical practice guidelines for management of HTPFD. METHODS AND FINDINGS A Delphi method of consensus development was used, comprising three survey rounds administered anonymously via web-based platform (Qualtrics® XM) to national experts in the field of HTPFD recruited through targeted invitation between September and December 2021. Twelve experts participated with backgrounds in urology, urogynecology, minimally invasive gynecology, and pelvic floor physical therapy (PFPT) participated. Panelists were asked to rate their agreement with rated evidence-based statements regarding HTPFD treatment. Statements reaching consensus were used to generate a consensus treatment algorithm. A total of 31 statements were reviewed by group members at the first Delphi round with 10 statements reaching consensus. 28 statements were reposed in the second round with 17 reaching consensus. The putative algorithm met clinical consensus in the third round. There was universal agreement for PFPT as first-line treatment for HTPFD. If satisfactory symptom improvement is reached with PFPT, the patient can be discharged with a home exercise program. If no improvement after PFPT, second line options include trigger or tender point injections, vaginal muscle relaxants, and cognitive behavioral therapy, all of which can also be used in conjunction with PFPT. Onabotulinumtoxin A injections should be used as third line with symptom assessment after 2-4two to four weeks. There was universal agreement that sacral neuromodulation is fourth line intervention. The largest identified barrier to care for these patients is access to PFPT. For patients who cannot access PFPT, experts recommend at-home, guided pelvic floor relaxation, self-massage with vaginal wands, and virtual PFPT visits. CONCLUSIONS A stepwise approach to the treatment of HTPFD is recommended, with patients often necessitating multiple lines of treatment either sequentially or in conjunction. However, PFPT should be offered first line. Why was this study done? High tone pelvic floor dysfunction is a highly prevalent neuromuscular disorders causing a range of lower urinary tract and defecatory symptoms, sexual dysfunction, and pelvic pain. Currently, there is no consensus or accepted clinical guidance to direct the management of these patients. What did the researchers do and find? Experts in urology, urogynecology, minimally invasive gynecology, and pelvic floor physical therapy generated a set of consensus practice statements to help guide the management of HTPFD using a rigorous Delphi process. Four tiers of treatment, with pelvic floor physical therapy as the first line treatment, followed by vaginal muscle relaxants, tender point injections, and/or cognitive behavioral therapy as second line, pelvic floor trigger point injection as third-line, and sacral neuromodulation as fourth line, were recommended for HTPFD management. Exceptions to sequential progression through this algorithm may be needed for patients with limited regional or financial access to the recommended treatments. What do these findings mean? A clinical care pathway for high-tone pelvic floor dysfunction will enable more effective care of patients and empower future studies to measure the effectiveness of each treatment option in a more systematic fashion. ### Competing Interest Statement A.L. Ackerman receives grant funding from Medtronic, Inc. and MicrogenDx. A.L. Ackerman is an advisor for Abbvie and Watershed Medical. ### Funding Statement There was no funding for this study ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors