Pelvic Organ ProlapsePT-POPNCT03244397
Physical Therapy on Pelvic Organ Prolapse
A study testing Physical therapy + educational strategy and Educational strategy in people with Pelvic Organ Prolapse, run by University of Alcala at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Physical therapy + educational strategy and Educational strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSpain
- Study dates
- 8 Aug 2017to 28 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with stage I or II pelvic organ prolapse (POP), as determined using the Pelvic Organ Prolapse Quantification (POP-Q) system.
Who cannot join
- Stage III or IV POP according to the POP-Q system.
- Previous conservative treatment or surgery for POP. Neurological, gynecological, or urological conditions that could interfere with the intervention or outcome assessment.
- Urinary tract infection or recurrent hematuria.
- Current pregnancy or vaginal delivery within the previous 6 months.
- Cognitive or language limitations that could prevent participants from understanding the study procedures, providing informed consent, completing the study questionnaires, or adequately participating in the intervention.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, 28805
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, 28871
About this study
Official title: Effectiveness of Physical Therapy on Pelvic Organ Prolapse Stages I & II
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.
Read more
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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Physical therapy + educational strategy, Educational strategy
- Keywords
- Pelvic organ prolapse; Pelvic floor muscle training; Physiotherapy; Pelvic floor rehabilitation; Conservative treatment; Women
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy + educational strategyOther
See arm/group descriptions
Educational strategyBehavioural
See arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy group | Experimental | 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. Receives: Other: Physical therapy + educational strategy |
| Control group | Active comparator | 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. Receives: Behavioral: Educational strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately post-intervention, 6 months, and 12 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start8 Aug 2017
- Primary completion10 Dec 2020
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: Experimental group and Control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Torres Lacomba, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244397
- Sponsor's protocol ID
- 21/2012
- Acronym
- PT-POP
- Status last verified
- Apr 2020
- First submitted
- 3 Aug 2017
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Therapy on Pelvic Organ Prolapse Stages I & II
- ClinicalTrials.gov ID
- NCT03244397
- Acronym / sponsor ID
- PT-POP / 21/2012
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse; Pelvic floor muscle training; Physiotherapy; Pelvic floor rehabilitation; Conservative treatment; Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: Experimental group and Control group
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy group | Experimental | Other: Physical therapy + educational strategyParticipants 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. |
| Control group | Active comparator | Behavioral: Educational strategyParticipants 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with stage I or II pelvic organ prolapse (POP), as determined using the Pelvic Organ Prolapse Quantification (POP-Q) system.
Key exclusion criteria (5 listed)
- Stage III or IV POP according to the POP-Q system.
- Previous conservative treatment or surgery for POP. Neurological, gynecological, or urological conditions that could interfere with the intervention or outcome assessment.
- Urinary tract infection or recurrent hematuria.
- Current pregnancy or vaginal delivery within the previous 6 months.
- Cognitive or language limitations that could prevent participants from understanding the study procedures, providing informed consent, completing the study questionnaires, or adequately participating in the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy + educational strategySee arm/group descriptions | Other | Physiotherapy group |
| Educational strategySee arm/group descriptions | Behavioural | Control group |
Primary outcome
Change in pelvic floor symptom distress assessed with the Spanish version of the Pelvic Floor Distress Inventory-20 (PFDI-20)
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.
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.
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)
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.
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.
3 secondary outcomes
Change in pelvic floor muscle strength assessed by perineal manometry
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
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
Time frame: Baseline, immediately post-intervention, 6 months, and 12 months post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy + educational strategy and Educational strategy in people with Pelvic Organ Prolapse, run by University of Alcala at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pelvic floor symptom distress assessed with the Spanish version of the Pelvic Floor Distress Inventory-20 (PFDI-20) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.