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Paper 36: Responsiveness of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) in Women Undergoing Surgical and Nonsurgical Treatment for Pelvic Organ Prolapse

Barber, M D.; Walters, M D.; Cundiff, G W.the PESSRI Trial Group

Journal of Pelvic Medicine and Surgery: 2005 - Volume 11 - Issue - p S17-S18
doi: 10.1097/01.spv.0000176111.07405.0d
Paper Presentations: AUGS Abstracts: 2005 26th Annual Scientific Meeting of The American Urogynecologic Society

The Cleveland Clinic Foundation, Cleveland, OH and Johns Hopkins Bayview Medical Center, Baltimore, MD

Disclosure – Grant/Research Support: American Medical Systems: M.D. Barber, M.D. Walters; Cook Ob/Gyn: G.W. Cundiff; Eli Lilly: M.D. Barber; Pfizer: M.D. Barber; Yamanuchi: M.D. Barber; Consultant: American Medical Systems: M.D. Walters; C.R. Bard: G.W. Cundiff; Other: Advisory Board - Eli Lilly: G.W. Cundiff

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OBJECTIVE:

To evaluate the responsiveness (ie, ability to capture clinically important change) of the PFDI and PFIQ in women with pelvic organ prolapse undergoing surgical and nonsurgical management.

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METHODS:

The responsiveness of the PFDI and PFIQ where assessed in 2 independent populations: 1) 42 women with ≥ stage 2 prolapse enrolled in an ongoing multicenter randomized trial comparing 2 different pessaries (pessary group) and 2) 64 women with stage ≥ stage 3 prolapse who underwent vaginal reconstructive surgery (surgery group). All subjects completed the PFDI and PFIQ at baseline and again either 3 months (pessary group) or 6 months (surgery group) after initiation of treatment. The pessary group also completed a visual analog scale (VAS) evaluating their satisfaction with the pessary. Responsiveness was assessed with standardized response mean (SRM), effect size (ES) and the paired t-test. For both SRM and ES, a value of 0.5–0.7 is considered moderate responsiveness, >0.80 to 1.0 is considered good and >1.0 is considered excellent.

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RESULTS:

In the pessary group, there was a significant improvement in the prolapse and urinary scales of the PFDI, with each demonstrating moderate responsiveness (prolapse: SRM 0.69, ES 0.68; urinary: SRM 0.57, ES: 0.49, P<0.001 for each). The colorectal scale of the PFDI and each of the 3 scales of the PFIQ demonstrated no significant change in scores with pessary use. The change in score of the prolapse and urinary scales of the PFDI and the PFIQ had significant positive correlation with satisfaction with the pessary (PFDI: r=0.61 & 0.66, P<0.001; PFIQ: r=0.40 & 0.54, P≤0.04). In the surgery group, there was a significant improvement in the prolapse, urinary, and colorectal scales of both the PFDI and PFIQ (P<0.01 for each). The prolapse and urinary scales of the PFDI demonstrated excellent responsiveness with SRM and ES ≥1.20 for the prolapse scale and ≥1.03 for the urinary scale. The colorectal scale of the PFDI and each of the 3 scales of the PFIQ demonstrated moderate responsiveness (SRM 0.60–0.70 and ES 0.55–0.61) after surgery. Six percent (4/64) of subjects in the surgery group developed recurrent prolapse beyond the hymen by 6 months after surgery. Those who developed recurrence had significantly less improvement in the prolapse scales of both the PFDI and PFIQ. After controlling for preoperative prolapse stage and baseline QOL scores, subjects in the surgery group had significantly greater improvement in each of the scales of the PFDI and the prolapse and urinary scales of the PFIQ than did the pessary group.

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CONCLUSION:

The PFDI and PFIQ are responsive to change in women undergoing treatment for pelvic organ prolapse. The PFDI is more responsive than the PFIQ. Vaginal reconstructive surgery appears to result in greater improvement in condition-specific quality of life than does pessary use.

© 2005 Lippincott Williams & Wilkins, Inc.