An interventional study of Physical therapy + educational strategy and Educational strategy in Pelvic Organ Prolapse, sponsored by University of Alcala. Completed at 2 sites in Spain. Open to female participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University of Alcala · Not applicable, Interventional, and Treatment
OBJECTIVE: To evaluate the effectiveness of an individualized pelvic floor physiotherapy programme combined with lifestyle education compared with lifestyle education alone in women with stage I or II pelvic organ prolapse (POP).
DESIGN: Randomized controlled clinical trial with blinded outcome assessment. A total of 120 women were randomly allocated to an experimental group receiving an individualized pelvic floor physiotherapy programme plus lifestyle education or to a control group receiving lifestyle education alone. Assessments were performed at baseline, immediately after the intervention, and at 3, 6, and 12 months.
PRIMARY OUTCOMES: Pelvic floor symptoms and their impact on daily life, assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7).
SECONDARY OUTCOMES: Anatomical pelvic organ prolapse stage and pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale and by perineal manometry.
DATA ANALYSIS: Treatment effectiveness will be evaluated by comparing changes over time between groups throughout the 12-month follow-up.
509 studies on the registry are indexed under Pelvic Organ Prolapse; 81 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 330 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →University of Alcala is the lead sponsor of 123 studies on the registry; 36 are open to participants now.
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Women with stage I or II pelvic organ prolapse (POP), as determined using the Pelvic Organ Prolapse Quantification (POP-Q) system.
Exclusion Criteria:
Participants allocated to this group will receive an individualized pelvic floor physiotherapy programme consisting of 16 sessions (45-50 minutes per session), delivered twice weekly for 8 weeks, in addition to the educational intervention described for the control group. The physiotherapy programme will include pelvic floor muscle training (PFMT), individualized according to pelvic floor muscle function assessed by vaginal palpation, biofeedback-assisted exercises, and hypopressive exercises. From the eighth session onwards, participants will also be instructed to perform the prescribed exercises daily at home.
Other: Physical therapy + educational strategy
Participants allocated to this group will receive an educational intervention consisting of six weekly sessions (40-45 minutes per session). The programme will include education on pelvic floor anatomy and pelvic organ function using printed materials and anatomical models, together with advice on modifiable lifestyle factors associated with pelvic floor symptoms, including weight management, heavy lifting, high-impact activities, constipation, smoking, and caffeine intake. Participants will also receive advice on appropriate toileting habits and will be taught the Knack manoeuvre to be performed before and during activities that increase intra-abdominal pressure.
Behavioral: Educational strategy
See arm/group descriptions
See arm/group descriptions
Change in pelvic floor symptom distress assessed with the Spanish version of the Pelvic Floor Distress Inventory-20 (PFDI-20)
The PFDI-20 is a 20-item patient-reported outcome measure assessing symptom distress related to pelvic floor disorders. It comprises three subscales: the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Colorectal-Anal Distress Inventory-8 (CRADI-8), and Urinary Distress Inventory-6 (UDI-6). Each subscale is scored from 0 to 100, with higher scores indicating greater symptom distress. The total PFDI-20 score ranges from 0 to 300, with higher scores indicating greater overall pelvic floor symptom distress.
Time frame: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
Change in the impact of pelvic floor symptoms on daily activities assessed with the Spanish version of the Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
The PFIQ-7 is a 21-item patient-reported outcome measure comprising three 7-item subscales: the Urinary Impact Questionnaire-7 (UIQ-7), Pelvic Organ Prolapse Impact Questionnaire-7 (POPIQ-7), and Colorectal-Anal Impact Questionnaire-7 (CRAIQ-7). Each subscale is scored from 0 to 100, with higher scores indicating greater impact of pelvic floor symptoms on daily activities. The total PFIQ-7 score ranges from 0 to 300, with higher scores indicating greater overall impact.
Time frame: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
Change in pelvic floor muscle strength assessed by perineal manometry
Pelvic floor muscle strength will be assessed using perineal manometry. Three maximal voluntary pelvic floor muscle contractions will be performed, and the mean value will be used for analysis. Higher values indicate greater pelvic floor muscle strength.
Time frame: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
Change in pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale
Pelvic floor muscle strength will be assessed by vaginal palpation using the Modified Oxford Scale, ranging from 0 (no contraction) to 5 (strong contraction). Higher scores indicate greater pelvic floor muscle strength.
Time frame: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
Change in pelvic organ prolapse stage assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system
Pelvic organ prolapse stage will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. POP will be classified as stage 0, I, II, III, or IV according to the most distal portion of the prolapse relative to the hymen. Lower stages indicate less severe prolapse.
Time frame: Baseline, immediately post-intervention, 6 months, and 12 months post-intervention.
Plan to share: No
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University of Alcala