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EndometriosisENDOGYMNCT07245537

ENDOGYM: A Holistic Approach With Pelvic Floor Physiotherapy and Yoga for Endometriosis Pain Relief

An observational study of Endometriosis, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the combined effects of Yoga practice and pelvic floor physiotherapy (PFP) on chronic pelvic pain (CPP) and dyspareunia in endometriosis patients. This is a retrospective study carried out from April 2024 to November 2024 conducted by University Hospital Modena (Italy). Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Endometriosis
What is being tested?
Yoga and Pelvic Floor Physiotherapy
How many people
82 participants
Where
1 siteItaly
Study dates
1 Apr 2024to 31 Aug 2025
How long will I take part?
3 Months
Phase
Observational
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 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Patients with an ultrasound and/or post-operative histological diagnosis of endometriosis followed at the Endometriosis and Pelvic Pain Center of the Mother-Infant Department, Institute of Obstetrics and Gynecology, University of Modena and Reggio Emilia (Italy).

Who may be able to join

  • women with an ultrasound and/or post-operative histological diagnosis of endometriosis
  • aged between 18-50 years
  • currently undergoing medical treatment (for at least 3 months before the start of the study), and/or who have previously undergone surgical treatment
  • with myofascial pain ≥ 7 (NRS scale) and deep dyspareunia ≥ 7 (NRS scale).

Who cannot join

  • being pregnant
  • undergoing surgery in the past 6 months
  • concurrent diagnosis of fibromyalgia
  • documented pelvic and/or spine trauma within 5 years of recruitment
  • patients with interstitial cystitis and > 2 urinary tract infections per year, unless possibly related to endometriosis (non-bacterial)
  • patients with recurrent vaginal infections, mucocutaneous inflammations of the vulva and vagina.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • AOU Policlinico di Modena

    Modena, Emilia-Romagna, 41125

Other trials in Italy

About this study

Official title: EndoGym Progetto di Riabilitazione Del Pavimento Pelvico e Trattamento Del Dolore Miofasciale e Dispareunia Tramite la Pratica Dello Yoga in Pazienti Con Diagnosi di Endometriosi.

The aim of this study is to evaluate the combined effects of Yoga practice and pelvic floor physiotherapy (PFP) on chronic pelvic pain (CPP) and dyspareunia in endometriosis patients.

This is a retrospective study carried out from April 2024 to November 2024 conducted by University Hospital Modena (Italy). A total of 82 women with confirmed diagnosis of endometriosis were initially enrolled in the ENDOGYM program. Among them, 50 patients (61%) were therefore included in the final analysis. ENDOGYM consists of 12 weekly sessions over a period of 3 months. It includes two PFP sessions, lasting 1 hour each (one at the start and one at the end of the program), and 12 Yoga sessions, once a week, each lasting 60 minutes. EHP-30 questionnaire was used before and after the program to evaluate women's QoL; NRS scale was used before, half-way and after the program to evaluate CPP and dyspareunia.

Conditions
Endometriosis
Being tested
Yoga, Pelvic Floor Physiotherapy
Keywords
endometriosis, yoga, pain, quality of life, complementary therapies
Medical subject headings
Endometriosis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YogaOther

    The Yoga sessions were designed to address specific physiological needs related to endometriosis, such as CPP, myofascial pain, chronic fatigue, and hormonal imbalance. The asanas were selected to stimulate the nervous system, promote blood circulation, and relax the pelvic muscles. The poses were adapted to avoid any direct pressure on the pelvic organs, fostering a sense of lightness and awareness. Deep breathing techniques were taught to reduce stress and improve tissue oxygenation, with a positive impact on pain management and immune function. The breathing exercises were often hypopressive to reduce the load on the pelvic area. The use of mindfulness was encouraged to increase awareness of bodily sensations, reduce anxiety, and improve emotional balance. The practice was not just "a physical activity" but an opportunity for the participant to deeply connect with her body, promoting an overall improvement in the QoL.

  • Pelvic Floor PhysiotherapyOther

    During the two one-hour sessions of PFP, various tools were used, such as balls of different textures and a cylindrical cushion provide tactile biofeedback and help identify the boundaries of the perineum. Patients were free to adjust the intensity of the feedback by choosing or removing the appropriate aid. By perceiving the different muscular layers of the perineum and altering the posture of the pelvis and lower limbs, patients learned about perineal movements, muscle activation, and myofascial tensions. The goal was to internalize the therapeutic exercises demonstrated and apply them in various daily life situations to maintain improvements in the perineal-pelvic structures.

Study groups in NCT07245537
Study groupRoleWhat they receive
Patients with endometriosis and chronic pelvic pain and/or dyspareunia under medical treatmentENDOGYM consists of 12 weekly sessions over a period of 3 months. It includes two PFP sessions, lasting 1 hour each (one at the start and one at the end of the program), and 12 Yoga sessions, once a week, each lasting 60 minutes. EHP-30 questionnaire was used before and after the program to evaluate women's QoL; NRS scale was used before, half-way and after the program to evaluate CPP and dyspareunia
Receives: Other: Yoga; Other: Pelvic Floor Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the combined effects of Yoga practice and pelvic floor physiotherapy (PFP) on chronic pelvic pain (CPP) in endometriosis patients

    Before the start of the project, a disease-specific questionnaire to measure the QoL of women with endometriosis, the Endometriosis Health Profile-30 (EHP-30) questionnaire, was used to collect data about pain, control and powerlessness, emotional well-being, social support, self-image, work life, sexual intercourse, relationship with children, the medical profession, treatment, and infertility. Response categories are evaluated using a five-point Likert scale (0-4), and each EHP-30 scale is converted into a scoring system ranging from 0 to 100, where 0 indicates the best possible health status and 100 represents the worst possible health status. The Italian version of EHP-30 was used. Finally, at the end of the project, the women completed the EHP-30 questionnaire again. Comparisons of EHP-30 total and domain scores before and after the ENDOGYM program were performed using paired t-tests (two-tailed).

    Measured: From enrollment to the end of the lessons at 3 months

Secondary outcomes (1)
  1. Evaluate the combined effects of Yoga practice and pelvic floor physiotherapy (PFP) on dyspareunia in endometriosis patients

    Before the start of the project, the NRS scale was used to collect data about deep dyspareunia in patients with endometriosis. An additional assessment of deep dyspareunia using the NRS scale was performed halfway through the process. Finally, at the end of the project, the women assessed their deep dyspareunia one last time using the NRS scale.

    Measured: From the enrollment till the end of the lessons at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start1 Apr 2024
  3. Primary completion30 Nov 2024
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
82 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07245537
Sponsor's protocol ID
511/2024/OSS/AOUMO
Acronym
ENDOGYM
Status last verified
Nov 2025
First submitted
29 Sep 2025
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Starzec-Proserpio M, Frawley H, Bo K, Morin M. Effectiveness of nonpharmacological conservative therapies for chronic pelvic pain in women: a systematic review and meta-analysis. Am J Obstet Gynecol. 2025 Jan;232(1):42-71. doi: 10.1016/j.ajog.2024.08.006. Epub 2024 Aug 13.

    PubMed 39142363
  • Jones G, Jenkinson C, Taylor N, Mills A, Kennedy S. Measuring quality of life in women with endometriosis: tests of data quality, score reliability, response rate and scaling assumptions of the Endometriosis Health Profile Questionnaire. Hum Reprod. 2006 Oct;21(10):2686-93. doi: 10.1093/humrep/del231. Epub 2006 Jul 4.

    PubMed 16820384
  • Lee SY, Koo YJ, Lee DH. Classification of endometriosis. Yeungnam Univ J Med. 2021 Jan;38(1):10-18. doi: 10.12701/yujm.2020.00444. Epub 2020 Aug 7.

    PubMed 32764213
  • Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle T, Warren DK, Lowder JL. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019 Mar;220(3):255.e1-255.e9. doi: 10.1016/j.ajog.2018.11.1106. Epub 2018 Dec 7.

    PubMed 30527941
  • Bazot M, Thomassin I, Hourani R, Cortez A, Darai E. Diagnostic accuracy of transvaginal sonography for deep pelvic endometriosis. Ultrasound Obstet Gynecol. 2004 Aug;24(2):180-5. doi: 10.1002/uog.1108.

    PubMed 15287057
  • Ravins I, Joseph G, Tene L. The Effect of Practicing "Endometriosis Yoga" on Stress and Quality of Life for Women with Endometriosis: AB Design Pilot Study. Altern Ther Health Med. 2023 Apr;29(3):8-14.

    PubMed 35839113
  • Samami E, Shahhosseini Z, Khani S, Elyasi F. Pain-focused psychological interventions in women with endometriosis: A systematic review. Neuropsychopharmacol Rep. 2023 Sep;43(3):310-319. doi: 10.1002/npr2.12348. Epub 2023 Jun 27.

    PubMed 37366616
  • Huang AJ, Rowen TS, Abercrombie P, Subak LL, Schembri M, Plaut T, Chao MT. Development and Feasibility of a Group-Based Therapeutic Yoga Program for Women with Chronic Pelvic Pain. Pain Med. 2017 Oct 1;18(10):1864-1872. doi: 10.1093/pm/pnw306.

    PubMed 28419385
  • Villemure C, Ceko M, Cotton VA, Bushnell MC. Insular cortex mediates increased pain tolerance in yoga practitioners. Cereb Cortex. 2014 Oct;24(10):2732-40. doi: 10.1093/cercor/bht124. Epub 2013 May 21.

    PubMed 23696275
  • Wojcik M, Szczepaniak R, Placek K. Physiotherapy Management in Endometriosis. Int J Environ Res Public Health. 2022 Dec 2;19(23):16148. doi: 10.3390/ijerph192316148.

    PubMed 36498220
  • van Reijn-Baggen DA, Han-Geurts IJM, Voorham-van der Zalm PJ, Pelger RCM, Hagenaars-van Miert CHAC, Laan ETM. Pelvic Floor Physical Therapy for Pelvic Floor Hypertonicity: A Systematic Review of Treatment Efficacy. Sex Med Rev. 2022 Apr;10(2):209-230. doi: 10.1016/j.sxmr.2021.03.002. Epub 2021 Jun 12.

    PubMed 34127429
  • Alboni C, Melegari S, Camacho Mattos L, Farulla A. Effects of osteopathic manipulative therapy on recurrent pelvic pain and dyspareunia in women after surgery for endometriosis: a retrospective study. Minerva Obstet Gynecol. 2024 Jun;76(3):264-271. doi: 10.23736/S2724-606X.23.05351-4. Epub 2023 Nov 23.

    PubMed 37997320
  • Del Forno S, Arena A, Pellizzone V, Lenzi J, Raimondo D, Cocchi L, Paradisi R, Youssef A, Casadio P, Seracchioli R. Assessment of levator hiatal area using 3D/4D transperineal ultrasound in women with deep infiltrating endometriosis and superficial dyspareunia treated with pelvic floor muscle physiotherapy: randomized controlled trial. Ultrasound Obstet Gynecol. 2021 May;57(5):726-732. doi: 10.1002/uog.23590.

    PubMed 33428320
  • Stratton P, Khachikyan I, Sinaii N, Ortiz R, Shah J. Association of chronic pelvic pain and endometriosis with signs of sensitization and myofascial pain. Obstet Gynecol. 2015 Mar;125(3):719-728. doi: 10.1097/AOG.0000000000000663.

    PubMed 25730237
  • Vercellini P, Somigliana E, Vigano P, Abbiati A, Daguati R, Crosignani PG. Endometriosis: current and future medical therapies. Best Pract Res Clin Obstet Gynaecol. 2008 Apr;22(2):275-306. doi: 10.1016/j.bpobgyn.2007.10.001. Epub 2007 Nov 26.

    PubMed 18036995

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.

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 4 inclusion and 6 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

Evaluate the combined effects of Yoga practice and pelvic floor physiotherapy (PFP) on chronic pelvic pain (CPP) in endometriosis patients (time frame: From enrollment to the end of the lessons at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07245537, which also lists 25 linked publications.

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 24 Nov 2025.

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